Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
3,638
Countries
21
Sites
227
Advanced tumors
To estimate the overall survival (OS)
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Aug 2018 → ongoing
- Decision date (initial)
- 2023-02-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-501254-10-00
- EudraCT number
- 2017-004417-42
- WHO UTN
- U1111-1274-2274
- ClinicalTrials.gov
- NCT03486873
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To estimate the overall survival (OS)
Secondary objectives 3
- To estimate modified progression free survival (PFS) per evaluation criteria used in the parent trial by investigator assessment for participants who received or are receiving First Course Phase study treatment with pembrolizumab or a pembrolizumab-based combination
- To estimate modified event free survival (EFS) per evaluation criteria used in the parent trial by investigator assessment for participants who received or are receiving First Course Phase study treatment with pembrolizumab or a pembrolizumab-based combination
- To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase study treatment
Conditions and MedDRA coding
Advanced tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall trial This is a multicenter, non-randomized and open-label, Phase III extension trial in participants with advanced solid tumors who previously enrolled in MSD-sponsored pembrolizumab trials. MSD pembrolizumab-based parent trials that will enroll their participants into this extension trial include non-randomized and randomized and single and multi-cohort trials with pembrolizumab monotherapy and a pembrolizumab-based combination. All participants included in an eligible pembrolizumab-based parent trial may roll over into KN-587 (including participants that had been treated/are being treated with pembrolizumab monotherapy, a pembrolizumab-based combination as well as with a control). Participants who had been treated/are being treated in the First Course Phase in their parent trial with a control (eg, chemotherapy) will enter Survival Follow-up (SFU) Phase of this trial and continue to be treated as per standard of care (SOC), which will not be provided by the Sponsor. These participants will be followed for survival status and start of new antineoplastic therapy, until death, withdrawal of consent, or the end of the trial. Those participants who discontinued trial treatment and entered SFU for reasons other than progressive disease (PD) will also be followed radiographically by the site per SOC until PD occurs. For any participant originating from a parent trial where crossover to pembrolizumab from control arm was permitted upon disease progression, KN-587 will continue to offer the opportunity of treatment with pembrolizumab, if pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. This study will evaluate efficacy including long term OS/OS2, progression-free survival (PFS/PFS2), DOR/DOR2, DOCR/DOCR2 and objective response rate (ORR/ORR2), as well as the safety and tolerability of pembrolizumab or a pembrolizumab-based combination.
|
2 | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready
- Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase
- (Applicable to Second Course Phase only) Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
- (Applicable to Second Course Phase only) Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- (Applicable to Second Course Phase only) Demonstrates adequate organ function
- (Applicable to Second Course Phase only) Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
- (Applicable to Second Course Phase only) A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.
- (Criteria for dosing with lenvatinib) Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications
- (Criteria for dosing with lenvatinib) For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib
- (Criteria for dosing with lenvatinib) Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse
Exclusion criteria 28
- (Applicable to Second Course Phase only) Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- (Applicable to Second Course Phase only) Has a known history of human immunodeficiency virus (HIV) infection
- (Applicable to Second Course Phase only) Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
- (Applicable to Second Course Phase only) Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
- (Applicable to Second Course Phase only) Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease
- (Applicable to Second Course Phase only) Has hepatic decompensation (Child-Pugh score >6 [class B and C])
- (Applicable to Second Course Phase only) Has uncontrolled thyroid dysfunction
- (Applicable to Second Course Phase only) Has uncontrolled diabetes mellitus
- (Applicable to Second Course Phase only) Has had an allogeneic tissue/solid organ transplant
- (Applicable to Second Course Phase only) Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
- (Applicable to Second Course Phase only) Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment
- (Applicable to Second Course Phase only) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase
- (Applicable to Second Course Phase only) Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
- (Applicable to Second Course Phase only) Has known active central nervous system metastases and/or carcinomatous meningitis
- (Applicable to Second Course Phase only) Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- (Applicable to Second Course Phase only) Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
- (Applicable to Second Course Phase only) Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
- (Applicable to Second Course Phase only) Has an active infection requiring systemic therapy
- (Criteria for dosing with lenvatinib) Has had major surgery within 3 weeks prior to first dose of study intervention(s)
- (Criteria for dosing with lenvatinib) Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
- (Criteria for dosing with lenvatinib) Has urine protein ≥1 g/24 hours
- (Criteria for dosing with lenvatinib) Has LVEF below the institutional (or local laboratory) normal range, as determined by MUGA or ECHO
- (Criteria for dosing with lenvatinib) Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- (Criteria for dosing with lenvatinib) Prolongation of QTcF interval to >480 ms
- (Criteria for dosing with lenvatinib) Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- (Criteria for dosing with lenvatinib) Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
- (Criteria for dosing with lenvatinib) Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug
- (Criteria for dosing with lenvatinib) Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall Survival (OS)
Secondary endpoints 7
- Modified Progression Free Survival (PFS) Per Evaluation Criteria Used in the Parent Trial
- Modified Event Free Survival (EFS) Per Evaluation Criteria Used in the Parent Trial
- Number of Participants Who Experience Serious Adverse Events (SAEs)
- Number of Participants Who Experience Adverse Events of Special Interest (AEOSI)
- Number of Participants Who Experience Clinically Significant Adverse Events (CSAE)
- Number of Participants Who Experience Events of Clinical Interest (ECI)
- Number of Participants Who Discontinue Study Treatment Due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD9364228 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 35000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD6003525 · Product
- Active substance
- Favezelimab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 28000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 12800 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9414231 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 87600 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414229 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 87600 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414230 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 87600 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414228 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2191500 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414227 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2191500 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Rohit Lal
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Rohit Lal
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Parexel International Corporation ORG-100007310
|
Auburndale, United States | Other |
Locations
21 EU/EEA countries · 227 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 30 | 6 |
| Belgium | Ongoing, recruiting | 40 | 8 |
| Czechia | Ongoing, recruiting | 15 | 6 |
| Denmark | Ongoing, recruiting | 45 | 2 |
| Estonia | Ongoing, recruiting | 10 | 1 |
| Finland | Ongoing, recruiting | 20 | 2 |
| France | Ongoing, recruiting | 250 | 48 |
| Germany | Ongoing, recruiting | 75 | 13 |
| Greece | Ongoing, recruiting | 11 | 5 |
| Hungary | Ongoing, recruiting | 100 | 17 |
| Ireland | Ongoing, recruiting | 40 | 5 |
| Italy | Ongoing, recruiting | 150 | 26 |
| Latvia | Ongoing, recruiting | 10 | 2 |
| Lithuania | Ongoing, recruiting | 15 | 2 |
| Netherlands | Ongoing, recruiting | 20 | 5 |
| Norway | Ongoing, recruiting | 50 | 3 |
| Poland | Ongoing, recruiting | 140 | 22 |
| Portugal | Ongoing, recruiting | 15 | 3 |
| Romania | Ongoing, recruiting | 27 | 7 |
| Spain | Ongoing, recruiting | 245 | 40 |
| Sweden | Ongoing, recruiting | 35 | 4 |
| Rest of world
Turkey, Israel, Russian Federation, United Kingdom, Australia, Korea, Republic of, India, Brazil, Puerto Rico, Japan, Malaysia, Chile, Switzerland, Costa Rica, Peru, Thailand, Colombia, Guatemala, New Zealand, United States, South Africa, Ukraine, Hong Kong, Mexico, Singapore, Taiwan, China, Philippines, Canada, Argentina
|
— | 2,295 | — |
Investigational sites
Krankenhaus Nord-Klinik Floridsdorf
Abteilung für Innere Medizin und Pneumologie, Bruenner Strasse 68, Floridsdorf, Vienna
Medical University Of Graz
Universitätsklinik für Dermatologie und Venerologie, Auenbruggerplatz 2, 8036, Graz
Medizinische Universitaet Innsbruck
Univ. Klinik für Dermatologie und Venerologie, Anichstraße 35, 6020, Innsbruck
SCRI CCCIT Ges.m.b.H.
Universität für Innere Medizin III, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Lungenabteilung /Pneumologie, Fadingerstrasse 1, 4020, Linz
Kepler Universitaetsklinikum GmbH
Klinik für Lungenheilkunde, Krankenhausstrasse 9, 4020, Linz
Az Maria Middelares Gent
Medical Oncology, Buitenring-Sint-Denijs 30, 9000, Gent
UZ Leuven
Gastroenterology, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Brussels
A.Z. Sint-Maarten
Pneumology, Liersesteenweg 435, 2800, Mechelen
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU UCL Namur
Pneumology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
UZ Leuven
Medical Oncology, Herestraat 49, 3000, Leuven
University Hospital Olomouc
Klinika plicních nemocí a tuberkulózy, I. P. Pavlova 185/6, Nova Ulice, Olomouc
Fakultni Nemocnice V Motole
Onkologická klinika 2.LF UK a FN Motol, V Uvalu 84/1, Motol, Prague 5
Fakultni Thomayerova nemocnice
Onkologická klinika 1.LF UK a FTN, Videnska 800, Krc, Prague 4
Masaryk Memorial Cancer Institute
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice V Motole
Pneumologická klinika 2.LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
University Hospital Olomouc
Onkologická klinika, I. P. Pavlova 185/6, Nova Ulice, Olomouc
Odense University Hospital
Onkologisk Afdeling R, J B Winsloews Vej 4, 5000, Odense C
Lillebaelt Hospital
Oncology Department, Beriderbakken 4, 7100, Vejle
Tartu University Hospital
Department of Radio and Oncotherapy, L. Puusepa Tn 1a, 50406, Tartu Linn
Tampere University Hospital
Outpatient clinic for gynecology, Teiskontie 35, 33520, Tampere
Turku University Central Hospital
Department of obstetrics and gynecology, Kiinamyllynkatu 4-8, 20520, Turku
Institut De Cancerologie De Lorraine
Oncology, 6 Avenue De Bourgogne, 54500, Vandouvre-Les-Nancy
CHU Besancon
Medical oncology, 3 Boulevard Alexandre Fleming, 25000, Besancon
Centre Hospitalier Universitaire De Toulouse
Pulmonology, Cedex 9, 2 Rue Viguerie, Toulouse
Clinique De L'Europe
Pneumology, 5 Allee Des Pays Bas, 80090, Amiens
Centre Hospitalier De Pau
Pneumology Department, 4 Boulevard Hauterive, Cs 17595, Pau Cedex
Centre Hospitalier Universitaire De Rennes
Pulmonology, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Universitaire De Nice
Dermatology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire Rouen
Pneumology Department, 1 Rue De Germont, Bp 96031, Rouen Cedex
Groupe Hospitalier Diaconesses Croix Saint Simon
Medical oncology, 125 Rue D Avron, 75020, Paris
Centre Hospitalier Universitaire De Toulouse
Department of Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Annecy Genevois
Departement of Dermatology, 1 Avenue De L Hopital, Bp 90074, Epagny Metz Tessy
Centre Hospitalier Regional Universitaire De Tours
Pulmonology, 2 Boulevard Tonnelle, 37000, Tours
Centre Francois Baclesse
Departement of Breast pathology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Montpellier
Departement d'Onco-Dermatology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopital Paul Brousse
Centre Hépato-Biliaire, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Centre Hospitalier Universitaire De Nantes
Medical Oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Le Mans
Centre de Cancérology de la Sarthe, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Jean Perrin
Oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centre Henri Becquerel
Hematology, Rue D Amiens, 76038, Rouen Cedex
Hopital Prive Clairval
Oncology, 317 Boulevard Du Redon, 13009, Marseille
Institut Gustave Roussy
Dermato- Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, Boulevard Tanguy Prigent, 29200, Brest
Assistance Publique Hopitaux De Paris
Lymphoid malignacies department, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Centre Hospitalier Regional Universitaire De Lille
Dermatology, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Toulouse
digestive oncology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Assistance Publique Hopitaux De Marseille
Oncodermatology, 264 Rue Saint Pierre, 13005, Marseille
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Medical oncology, 229 Cours De L Argonne, 33000, Bordeaux
Assistance Publique Hopitaux De Marseille
Oncology, 265 Chemin Des Bourrely, 13015, Marseille
Assistance Publique Hopitaux De Paris
Dermatology, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt
Assistance Publique Hopitaux De Paris
Oncology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Assistance Publique Hopitaux De Paris
Digestiv and Medical oncology, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Poitiers
Dermatology, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Dermatology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Intercommunal Creteil
Pneumology, 40 Avenue De Verdun, 94000, Creteil
Centre De Lutte Contre Le Cancer Eugene Marquis
Medical Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
GIE Groupe hospitalier Paris Saint-Joseph
Pulmonology, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Assistance Publique Hopitaux De Paris
Dermatology and Venereology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Assistance Publique Hopitaux De Paris
Dermatology, 125 Rue De Stalingrad, 93000, Bobigny
Institut De Cancerologie De L Ouest
Oncology medical, Bd Du Professeur Jacques Monod, 44800, St Herblain
Centre Hospitalier Universitaire De Bordeaux
Departement of Dermatology, unit of onco-dermatology, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Oncodermatology, 1 Avenue Claude Vellefaux, 75010, Paris
Les Hopitaux Universitaires De Strasbourg
Pulmonology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Assistance Publique Hopitaux De Paris
Pulmonology, 4 Rue De La Chine, 75020, Paris
Hospital Foch
Medical oncology, 40 Rue Worth, 92150, Suresnes
Sainte Catherine Institut Du Cancer Avignon-Provence
Department of Oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Institut fuer Klinische Krebsforschung IKF GmbH
Institut für Klinisch-Onkologische Forschung, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsklinikum Tuebingen AöR
Innere Medizin VIII, Otfried-Mueller-Strasse 14, Nordstadt, Tuebingen
Medizinische Hochschule Hannover
Klinik für Dermatologie, Allergologie und Venerologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Helios Klinikum Emil Von Behring GmbH
Klinik für Pneumologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Haematologisch Onkologische Praxis Eppendorf
Hämatologisch-Onkologische Praxis Eppendorf, Eppendorfer Landstraße 42, Eppendorf, Hamburg
Pneumologisches Forschungsinstitut An Der Lungenclinic Grosshansdorf GmbH
LungenClinic Grosshansdorf GmbH, Wöhrendamm 80, 22927, Großhansdorf
Universitaet Des Saarlandes
Innere Medizin V, Kirrberger Strasse 100, 66421, Homburg
Klinikum der Universitat Munchen AöR
Klinik und Poliklinik für Dermatologie und Allergologie, Frauenlobstraße 9-11, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Charite Comprehensive Cancer Center, Hindenburgdamm 30, Lichterfelde, Berlin
Elbe Kliniken Stade Buxtehude Elbe Klinikum Buxtehude gGmbH
Hautkrebszentrum Buxtehude, Am Krankenhaus 1, 21614, Buxtehude
Srh Wald-Klinikum Gera GmbH
Zentrum für Klinische Studien, Strasse Des Friedens 122, Debschwitz, Gera
Universitatsklinikum Erlangen AöR
Frauenklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Laiko General Hospital Of Athens
1st Department of Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Melanoma and Skin Cancer Center, Dragoumi Ionos 5 I, 161 21, Athens
Laiko General Hospital Of Athens
Department of Clinical Trials, Hematology Clinic and Βone Μarrow Τransplantation Unit, NKUA,, Sevastoupoleos 16, 115 26, Athens
Laiko General Hospital Of Athens
Hematology Department, Agiou Thoma (goudi) 17, 115 27, Athens
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Matrai Gyogyintezet
Pulmonologia Osztaly, Matrahaza Hrsz 7151, 3200, Gyongyos
Bekes Varmegyei Koezponti Korhaz
Aktív Tüdőgyógyászati Osztály, Sitka Tanya 1, 5700, Gyula
National Koranyi Institute
VI. Tüdőbelosztály, Piheno Ut 1, 1121, Budapest XII
University Of Debrecen
Belgyógyászati Klinika, B épület, Hematológia, Nagyerdei Korut 98, 4032, Debrecen
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Onkoradiológiai Osztály, Markusovszky Str. 5, 9700, Szombathely
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Pulmonológiai Osztály C épület 3-4 emelet, Seregelyesi Ut 3, 8000, Szekesfehervar
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkológiai es Sugárterápiás Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
Orszagos Onkologiai Intezet
Gyógyszerterápiás Központ Urogenitális Tumorok és Klinikai Farmakológiai Osztály "KEMOTERÁPIA C", Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonológia Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Reformatus Pulmonologiai Centrum
Onkopulmonológiai Járóbeteg Centrum, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Klinikai Onkológiai Osztály, Tallian Gyula Utca 20-32, 7400, Kaposvar
Zala Megyei Szent Rafael Korhaz
Pulmonológiai Osztály, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Uzsoki Street Hospital
Onkoradiológiai Központ, Uzsoki Utca 29-41, 1145, Budapest XIV
Semmelweis University
Belgyogyászati és Hematológiai Klinika, Szentkiralyi Utca 46, Kerulet, Budapest VIII
University Of Debrecen
Onkológia Klinika, Nagyerdei Korut 98, 4032, Debrecen
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Onkológiai Központ, Toszegi Ut 21, 5000, Szolnok
Adelaide And Meath Hospital
Tallaght University Hospital, Tallaght By-Pass, Tallaght, Dublin 24
St Vincent's University Hospital
Clinical Research Centre, Nutley Lane, Elm Park, Dublin 4
Beaumont Hospital
Clinical Trials & Research Unit, Beaumont Road, Beaumont, Dublin 9
Mater Misericordiae University Hospital
Institute For Cancer Research, Eccles Street, D07 R2WY, Dublin 7
St James's Hospital
Cancer Clinical Trials Office, James's Street, Ireland, Dublin 8
Cliniche Gavazzeni S.p.A.
U.O. Oncologia Medica, Via Mauro Gavazzeni 21, 24125, Bergamo
Azienda Ospedaliera S Maria Di Terni
S. C. Oncologia, Viale Tristano Di Joannuccio 1, 05100, Terni
Fondazione IRCCS Policlinico San Matteo
Dip.Scienze mediche e malattie infettive - Oncologia Medica, Viale Camillo Golgi 19, 27100, Pavia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
S.S.D. Oncologia Polmonare, Largo Francesco Vito 1, 00168, Rome
San Camillo Forlanini Hospital
Oncologia Medica, Circonvallazione Gianicolense 87, 00152, Rome
Istituto Oncologico Veneto
U.O.C. Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Humanitas Research Hospital
Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. di Oncologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Oncologia Medica 2, Corso Bramante 88, 10126, Turin
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
UOC Oncologia, Piazza Oms 1, 24127, Bergamo
IRCCS Ospedale Policlinico San Martino
Oncologia Medica 1, Largo Rosanna Benzi 10, 16132, Genoa
Istituti Fisioterapici Ospitalieri
Oncologia Medica, Via Elio Chianesi N 53, 00144, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Hospital Santa Maria Della Misericordia
S.C. Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC di Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Senese
UOC Immunoterapia, Strada Delle Scotte 14, 53100, Siena
Fondazione IRCCS San Gerardo Dei Tintori
U.O.C. Centro di Ricerca di Fase I, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncologia Medica, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
SSD Oncologia Medica Addarii, Via Pietro Albertoni 15, 40138, Bologna
Ospedale San Raffaele S.r.l.
UO Ginecologia Settore C, Via Olgettina 60, 20132, Milan
IRCCS Istituto Nazionale Tumori - Fondazione Pascale
Melanoma, Immunoterapia Oncologica e Terapie Innovative, Via Mariano Semmola 53, 80131, Naples
Azienda Ospedaliero Universitaria Parma
Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma
Centro Di Riferimento Oncologico Di Aviano
SOC. Oncologia Medica e dei Tumori Immunocorrelati, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Per L'Emergenza Cannizzaro
" U.O.C Oncologia Medica", Via Messina 829, 95126, Catania
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ginecologia oncologica, Largo Francesco Vito 1, 00168, Rome
European Institute Of Oncology S.r.l.
Divisione di Oncologia Medica Urogenitale e Cervico Facciale, Via Giuseppe Ripamonti 435, 20141, Milan
Rigas Austrumu kliniska universitates slimnica SIA
Latvia Oncology center, Hipokrata Iela 2, 1038, Riga
Liepajas Regionala Slimnica SIA
Oncology department, Slimnicas Iela 25, 3414, Liepaja
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Chemotherapy department, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Vilnius University Hospital
Center of Hematology, Oncology and Transfusion, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Stichting Sint Antonius Ziekenhuis
Interne Geneeskunde, Koekoekslaan 1, 3435 CM, Nieuwegein
University Medical Center Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Amsterdam UMC
Medical Oncology, Meibergdreef 9, 1105 AZ, Amsterdam
Stichting Radboud University Medical Center
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
Thorax Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Oslo University Hospital HF
Avdeling for kreftbehandling, Kreftklinikken, Montebello, Ullernchausséen 70, Oslo
Helse Bergen HF
Lungevadelingen, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Avdeling for kreftbehandling, Kreftklinikken, Montebello, Ullernchausséen 70, Oslo
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej/ Chemioterapi, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Mruk-Med I Sp. z o.o.
n/a, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Centrum Wsparcia Badań Klinicznych, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Med – Polonia Sp. z o.o.
Med – Polonia Sp. z o.o., Ul. Obornicka 262, 60-693, Poznan
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Onkologii Klinicznej z Pododdzialem Dziennym, Os. Zlotej Jesieni 1, 31-826, Cracow
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski
Przychodnia Lekarska Komed, Ul. Wojska Polskiego 6, 62-500, Konin
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Ginekologii Onkologicznej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Onkologii Klinicznej, Ul. Garncarska 11, 31-115, Cracow
Szpital Rejonowy Im. Dr Jozefa Rostka W Raciborzu
Dzienny Oddział Chemioterapii, Ul. Gamowska 3, 47-400, Raciborz
Bialostockie Centrum Onkologii Im M Sklodowskiej-Curie W Bialymstoku
Oddział onkologii klinicznej z pododdziałem chemioterapii dziennej, Ul. Ogrodowa 12, 15-027, Bialystok
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Onkologii, Ulica Szaserow 128, 04-141, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im Prof Tadeusza Koszarowskiego W Opolu
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-001, Opole
Szpitale Pomorskie Sp. z o.o.
Szpital Morski im. PCK Oddział Onkologii i Radioterapii, Onkologia Kliniczna Leczenie 'Jednego Dnia', Ul. Powstania Styczniowego 1, 81-519, Gdynia
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Onkologii, Oddział Chemioterapii, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Lux Med Onkologia Sp. z o.o.
Szpital Szamocka; Oddział Onkologii Klinicznej/Chemioterapii, Ul. Szamocka 6, 01-748, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć, Ul. Garbary 15, 61-866, Poznan
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Serviço de Pneumologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Champalimaud Clinical Centre
Unidade do Pulmão, Avenida Brasilia S/n, 1400-038, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Sigmedical Services S.R.L.
Oncologie Medicala, Bis The Building Corp A, Strada Zamca Nr 21 Et 3, Suceava
Institutul Clinic Fundeni
Oncologie Medicala, Soseaua Fundeni 258, 022328, Bucharest
Oncomed S.R.L.
Oncologie Medicala, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Cardiomed S.R.L.
Oncologie Medicala, Strada Republicii Nr 30, 400015, Cluj-Napoca
Memorial Healthcare International S.R.L.
Oncologie Medicala, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Hospital Universitari Vall D Hebron
Oncology (Gastric & Esophageal & Colorectal cancer therapeutic area), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Catalan Institute Of Oncology
Medical Oncology, Carretera Canyet S/n, 08916, Badalona
Clara Campal Comprehesive Cancer Center
START-Madrid CIOCC, Calle Ona 10, 28050, Madrid
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario La Paz
Servicio de Oncología Médica, Paseo Castellana 261, 28046, Madrid
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
Hospital Universitario Marques De Valdecilla
Medical Oncology, 5 Planta, Avenida Valdecilla S/n, Santander
Hospital General Universitario Gregorio Maranon
Oncología Médica, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology (Prostatic & Renal & Bladder cancer therapeutic area), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitari Vall D Hebron
Oncology (Skin Cancer & Woman cancer therapeutic area), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga
Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Hospital De La Santa Creu I Sant Pau
Medical Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
Oncology (Lung & Head & Neck cancer therapeutic area), Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Macarena
Oncología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Catalan Institute Of Oncology
Medical Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Institut D Investigacio Sanitaria Pere Virgili
Oncology, Calle De L'escorxador S/n, 43003, Tarragona
Hospital Universitario Quironsalud Madrid
Servicio de Oncología Médica, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Jaen
Oncología Médica, Avenida Del Ejercito Espanol 10, 23007, Jaen
Fundacion Onkologikoa Fundazioa
Oncología, Pasealeku Doct. Begiristain 121, 20014, Donostia
University Clinic Of Navarra
Medical Oncology, Avenida De Pio XII 36, 31008, Pamplona
Hospital Universitario Central De Asturias
Medical Oncology Department, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Complejo Hospitalario Universitario Insular Materno Infantil
Oncología Médica, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Del Mar
Medical Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinico Universitario Lozano Blesa
Medical Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Fundacion Jimenez Diaz
Oncology & Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
Hospital Universitario Puerta De Hierro De Majadahonda
Oncología, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario 12 De Octubre
Servicio de Oncología Médica, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital General Universitario De Alicante
Oncología Médica, ª Centro De Diagnosticos, Avinguda Del Pintor Baeza 12, Alicante
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Onkologmottagningen, Diagnosvagen 11, Harlanda, Gothenburg
Karolinska University Hospital
Fas-1 enheten, Team Cancer, Eugeniavagen 3, 171 64, Solna
Uppsala University Hospital
Blod och Tumörsjukdomar, Akademiska Sjukhuset, 751 85, Uppsala
Region Vasterbotten
Cancercentrum KFE, Koksvagen 11, Alidhem, Umea
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2018-12-19 | 2019-01-07 | |||
| Belgium | 2019-02-05 | 2019-02-20 | |||
| Czechia | 2020-02-12 | 2020-02-28 | |||
| Denmark | 2020-02-25 | 2020-03-10 | |||
| Estonia | 2021-12-21 | 2022-03-07 | |||
| Finland | 2021-02-25 | 2021-03-18 | |||
| France | 2018-09-24 | 2018-09-24 | |||
| Germany | 2018-09-25 | 2018-10-15 | |||
| Greece | 2024-01-04 | 2024-01-05 | |||
| Hungary | 2020-02-18 | 2020-03-06 | |||
| Ireland | 2021-04-09 | 2021-05-05 | |||
| Italy | 2018-09-21 | 2018-10-31 | |||
| Latvia | 2022-03-04 | 2022-03-16 | |||
| Lithuania | 2020-12-10 | 2020-12-11 | |||
| Netherlands | 2018-12-14 | 2019-01-14 | |||
| Norway | 2018-09-26 | 2018-11-28 | |||
| Poland | 2020-08-20 | 2020-09-03 | |||
| Portugal | 2021-01-13 | 2021-01-22 | |||
| Romania | 2022-08-18 | 2022-09-02 | |||
| Spain | 2018-08-29 | 2018-09-21 | |||
| Sweden | 2018-08-24 | 2018-11-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 268 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-501254-10_GRC_EL_SM35_for pub | 8 |
| Protocol (for publication) | D1_Protocol_2022-501254-10_SM35_for pub | 08 |
| Protocol (for publication) | D1_PSP_for pub | 05R |
| Recruitment arrangements (for publication) | CTIS Placeholder document 3475-587 | 31Jan2022 |
| Recruitment arrangements (for publication) | Danish Attachment To Protocol_DNK_For publication | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_AUT_for pub | 31JAN2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_English_for pub | 17JAN2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_for pub | 15JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_DA_for pub | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_Spanish_for publication | 03APR2018 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_EST_EN_ for pub | 18Jan2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | 17JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EL_for pub | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_IRL_EN_SM35_for pub | 27MAR2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LTU_EN_ for pub | 18Jan2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LVA_EN_ for pub | 18Jan2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_NL_for pub | 26JAN2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NOR_EN_for pub | 24JAN2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM36_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_PRT_EN_for pub | 22FEB2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ROU_for pub | 16JAN2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_HUN_EN_for pub | 18Jan2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_SWE_SV_for pub | 1-2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_POL_PL_SM36_for pub | 03JUL2025 |
| Recruitment arrangements (for publication) | Recruitment Arrangements and Informed Consent Procedure_FIN_Finnish_for publication | 09SEP2020 |
| Subject information and informed consent form (for publication) | ICF_Optional blood sample_SWE_Swedish_for publication | 20AUG2018 |
| Subject information and informed consent form (for publication) | ICF_Optional stool sample_SWE_Swedish_for publication | 20AUG2018 |
| Subject information and informed consent form (for publication) | L1_ICF Optional dosing change_NOR_NN_for pub | 30JAN2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_AUT_DE_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_EN_for pub | V0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_FR_for pub | V0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_NL_for pub | V0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_CZE_CS_for pub | czech v1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_DEU_DE_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_DNK_DA_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_ES_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_EST_ET_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_EST_RU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_FIN_FI_for pub | V0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_FRA_FR_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_GRC_EL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_HUN_HU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_IRL_EN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ITA_IT_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_LTU_LT_for pub | V0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_LVA_LV_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_LVA_RU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_NLD_NL_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_NOR_NN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_POL_PL_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ROU_EN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ROU_RO_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_SWE_SV_for pub | V0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum MK-4280-MK-4280A_GRC_EL_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum Olaparib_FIN_FI_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum olaparib_GRC_EL_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenva_CZE_CS_SM35_for pub | cz v1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenvatinib_DEU_DE_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Lenvatinib_ESP_ES_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Lenvatinib_FIN_FI_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenvatinib_FRA_FR_SM35-RFI005_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenvatinib_GRC_EL_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenvatinib_NOR_NN_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Lenvatinib_POL_PL_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenvatinib_ROU_EN_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_lenvatinib_ROU_RO_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_LTU_EN_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-3475_EST_EE_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-3475_EST_RU_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-3475_LTU_LT_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-3475_LVA_LV_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-3475_LVA_RU_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-4280 and MK-4280A_ESP_ES_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-4280 and MK-4280A_POL_PL_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK-4280A_LTU_EN_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK4280 - MK4281A_DEU_DE_SM36_RFI003_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK4280_MK4280A_FRA_FR_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK4280_MK4280A_ROU_EN_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK4280_MK4280A_ROU_RO_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_MK7339_CZE_CS_SM36_for pub | cz v2 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Olaparib_AUT_DE_SM35-RFI14_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_olaparib_DEU_DE_SM36_RFI003_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Olaparib_ESP_ES_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Olaparib_FIN_FI_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_olaparib_FRA_FR_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_olaparib_NOR_NN_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Olaparib_POL_PL_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_olaparib_ROU_EN_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_olaparib_ROU_RO_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Pembrolizumab_AUT_DE_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_pembrolizumab_DEU_DE_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Pembrolizumab_ESP_ES_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Pembrolizumab_FIN_FI_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_pembrolizumab_FRA_FR_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_pembrolizumab_GRC_EL_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_pembrolizumab_NOR_NN_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_Pembrolizumab_POL_PL_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_pembrolizumab_ROU_EN_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum side effects_pembrolizumab_ROU_RO_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_BEL_EN_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_BEL_FR_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_BEL_NL_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_DNK_DA_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_HUN_HU_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_IRL_EN_SM35-RFI007_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_ITA_IT_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_PRT_PT_SM35_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Lenvatinib_SWE_SV_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK-4280 and MK4280A_ITA_IT_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK-4280A_SWE_SV_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK3475_CZE_CS_SM37_for pub | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK4280 and MK4280A_BEL_EN_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK4280 and MK4280A_BEL_FR_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK4280 and MK4280A_BEL_NL_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_MK4280_CZE_CS_SM36_for pub | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_BEL_EN_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_BEL_FR_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_BEL_NL_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_DNK_DA_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_HUN_HU_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_IRL_EN_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_ITA_IT_SM36_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_PRT_PT_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Olaparib_SWE_SV_SM36_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_BEL_EN_SM35_RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_BEL_EN_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_BEL_FR_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_BEL_NL_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_DNK_DA_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_pembrolizumab_HUN_HU_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_IRL_EN_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_ITA_IT_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_PRT_PT_SM37_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Pembrolizumab_SWE_SV_SM37_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent GDPR_CZE_Czech_for pub | Czech v3 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_1750_PRT_PT_SM36-RFI004_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_1753_PRT_PT_SM36-RFI004_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_AUT_DE_SM35_for pub | 4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_EN_SM35-RFI017_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_FR_SM35-RFI017_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_NL_SM35-RFI017_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_SM35_for pub | czech v10R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM37-RFI002_for pub | AM04 4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_SM36_for pub | AM04_4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM36_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_EST_ET_SM35-RFI008_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_EST_RU_SM35-RFI008_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_FI_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_SV_for pub | AM02V2-02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM35-RFI005_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_GRC_EL_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM35_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_IRL_EN_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LTU_LT_SM36_for pub | AM04v4.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LVA_LV_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LVA_RU_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_SM37_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NOR_NN_SM35_for pub | AM04v4-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_Patientenkontakte_AUT_DE_2951_for pub | 12JUN2018 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_Patientenkontakte_AUT_DE_2954_for pub | 23DEC2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_Patientenkontakte_AUT_DE_2955_for pub | 26JAN2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM35_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_PT_SM36-RFI004_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_EN_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_RO_SM35_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_SM35_for pub | AM4v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_SM35_for pub | 01APR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_CZE_CS_for pub | 4R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_ESP_ES_SM36_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_EST_ET_SM35-RFI008_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_EST_RU_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_FIN_FI_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_FIN_SV_for pub | AM01v1-01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_FRA_FR_SM35-RFI005_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_HUN_HU_SM35_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_IRL_EN_SM35-RFI007_for pub | AM03v3-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_ITA_IT_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_LTU_LT_SM36-RFI007_for pub | AM03v3.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_LVA_LV_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_LVA_RU_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_NOR_NN_SM35-RFI003_for pub | AM03v3-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_POL_PL_SM35_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_ROU_EN_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_ROU_RO_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_SWE_SV_SM35_for pub | AM3 v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional dosing change_CZE_Czech_for publication | AM01v1-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional pregnancy follow-up_FIN_Finnish_for publication | 04May2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional pregnancy follow-up_FIN_Swedish_for publication | 09Jun2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional withdrawal_AUT_German_for publication | 08Aug2018 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_German_for pub | 09JAN2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_addendum_NLD_NL_for pub | AM01_v1-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_addendum_progression consent_PRT_PT_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_SM35_for pub | 01APR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_AUT_DE_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_BEL_Dutch_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_BEL_English_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_BEL_French_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_DEU_German_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_DNK_DA_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_ESP_ES_for pub | AM01_1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_EST_ET _for pub | AM01v1-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_EST_RU _for pub | AM01v1-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_FIN_FI_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_FIN_SV_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_FRA_FR_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_GRC_EL_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_HUN_HU_for pub | AM01v1-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_IRL_EN_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_ITA_IT_SM35_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_LTU_LT _for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_LVA_LV_for pub | AM01_1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_LVA_RU_for pub | AM01_1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_POL_PL_SM35_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_PRT_PT_for pub | AM01_v1-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_ROU_EN_for pub | AM01_1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_dosing change_ROU_RO_for pub | AM01_1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_EN_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_FR_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_NL_SM35-RFI017_for pub | 000 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_SM36_for pub | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_SM35_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_PRT_PT_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner data privacy_ITA_IT_SM35_for pub | 01APR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_EN_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_FR_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_NL_SM35-RFI017_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_SM35_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HUN_HU_SM35_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ITA_IT_SM35_for pub | 01APR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_survival follow-up_AUT_DE_SM35_for pub | 3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_survival follow-up_DEU_DE_SM35_for pub | 6R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_survival follow-up_DNK_DA_SM35_for pub | 3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_survival follow-up_GRC_EL_SM35_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_withdrawal_IRL_EN_for pub | V1-00A |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_withdrawal_PRT_PT_for pub | 00 |
| Subject information and informed consent form (for publication) | L2_Patient advocacy_AUT_DE_SM36-RFI005_for pub | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient contacts per site_2952_AUT_DE_SM37_for pub | 24NOV2025R |
| Subject information and informed consent form (for publication) | L2_Patient contacts per site_2956_AUT_DE_SM35_for pub | 21JAN2025R |
| Subject information and informed consent form (for publication) | L2_Patient contacts per site_2957_AUT_DE_SM36_for pub | 07JUL2025R |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_HUN_HU_SM35_for pub | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Keytruda_SM35_for pub | 06FEB2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_AUT_DE_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_BEL_DE_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_BEL_FR_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_BEL_NL_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_CZE_CS_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_DEU_DE_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_ESP_ES_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_EST_EN_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_FRA_FR_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_GRC_EL_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_HUN_HU_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_ITA_IT_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_LTU_LT_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_LVA_EN_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_NLD_NL_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_POL_PL_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_PRT_PT_SM36_for pub | 3 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_ROU_RO_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501254-10_SWE_SV_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-50125410_NOR_NN_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-501254-10_AUT_DE_SM35_for pub | AM08 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-501254-10_CZE_CS_SM35_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-501254-10_PRT_PT_SM35_for pub | 24MAR2025 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-501254-10_ROU_RO_SM35_for pub | AM08 |
Application history
34 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-30 | Spain | No conclusion 2022-12-12
|
2022-12-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-02-24 | Spain | Acceptable 2023-05-29
|
2023-05-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-06-06 | Spain | Acceptable | 2023-06-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-06-06 | Acceptable | 2023-07-20 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-06-07 | Acceptable | 2023-07-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-11 | 2023-06-07 | Acceptable | 2023-07-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-12 | 2023-06-07 | Acceptable | 2023-08-14 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2023-06-23 | 2023-09-13 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-13 | 2023-06-26 | Acceptable | 2023-08-14 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-15 | 2023-07-19 | Acceptable | 2023-09-20 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-16 | 2023-07-28 | Acceptable | 2023-08-10 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-14 | 2023-08-04 | Acceptable | 2023-09-29 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-17 | 2023-08-08 | Acceptable | 2023-08-28 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-18 | 2023-09-01 | Acceptable | 2023-10-19 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-19 | 2023-09-08 | Acceptable | 2023-10-13 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-20 | 2023-09-14 | Acceptable | 2023-10-10 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-21 | 2023-09-19 | Acceptable | 2023-11-16 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-22 | 2023-10-20 | Acceptable | 2023-11-13 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-28 | 2023-11-28 | ||
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-11-28 | 2023-11-28 | ||
| 21 | SUBSTANTIAL MODIFICATION | SM-23 | 2024-01-25 | Spain | Acceptable 2024-05-07
|
2024-05-07 |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-15 | Acceptable 2024-05-07
|
2024-05-15 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-26 | 2024-05-16 | Spain | Acceptable | 2024-06-03 |
| 24 | SUBSTANTIAL MODIFICATION | SM-28 | 2024-05-16 | Acceptable | 2024-06-21 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-30 | 2024-05-24 | Acceptable | 2024-07-05 | |
| 26 | SUBSTANTIAL MODIFICATION | SM-27 | 2024-05-30 | Acceptable | 2024-09-09 | |
| 27 | SUBSTANTIAL MODIFICATION | SM-31 | 2024-06-14 | Acceptable | 2024-07-22 | |
| 28 | SUBSTANTIAL MODIFICATION | SM-29 | 2024-06-28 | Acceptable | 2024-08-07 | |
| 29 | SUBSTANTIAL MODIFICATION | SM-32 | 2024-09-24 | Spain | Acceptable 2024-11-19
|
2024-11-19 |
| 30 | SUBSTANTIAL MODIFICATION | SM-33 | 2025-01-09 | Acceptable | 2025-01-30 | |
| 31 | SUBSTANTIAL MODIFICATION | SM-34 | 2025-01-10 | Acceptable | 2025-02-12 | |
| 32 | SUBSTANTIAL MODIFICATION | SM-35 | 2025-04-07 | Spain | Acceptable 2025-07-14
|
2025-07-15 |
| 33 | SUBSTANTIAL MODIFICATION | SM-36 | 2025-08-07 | Spain | Acceptable 2025-10-14
|
2025-10-14 |
| 34 | SUBSTANTIAL MODIFICATION | SM-37 | 2025-12-16 | Spain | Acceptable 2026-03-03
|
2026-03-03 |