Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
638
Countries
6
Sites
23
Advanced solid tumors
1. To compare MK-7684A to pembrolizumab (MK-3475) alone with respect to ORR per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1. 2. To compare MK-7684A to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed BICR in participant…
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
- 13 Sep 2021 → 5 Aug 2025
- Decision date (initial)
- 2024-02-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-505284-36-00
- EudraCT number
- 2021-001009-56
- WHO UTN
- U1111-1291-4290
- ClinicalTrials.gov
- NCT05007106
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy, Pharmacokinetic, Dose response, Pharmacodynamic
1. To compare MK-7684A to pembrolizumab (MK-3475) alone with respect to ORR per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
2. To compare MK-7684A to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
3. To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to ORR per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding 1) those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1, 2) those enrolled in Cohort I.
4. To evaluate MK-7684A in combination with other anticancer therapies with respect to PFS per RECIST 1.1 at 9 months (PFS-9) and 12 months (PFS-12) as assessed by the investigator in participants with previously untreated BRCA1/2 nonmutated and HRD-negative advanced epithelial ovarian cancer enrolled in Cohort I.
Secondary objectives 8
- To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to OS in participants with selected solid tumors.
- To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to PFS per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
- To evaluate MK-7684A alone with respect to DOR per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PDL1 (CPS ≥1) enrolled in Cohort A1.
- To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to DOR per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
- To compare MK-7684A to pembrolizumab alone with respect to ORR per RECIST 1.1 as assessed by investigator in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
- To compare MK-7684A to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by investigator in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1
- To evaluate change from baseline in HRQoL using the EORTC QLQ-C30 in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
- To evaluate the safety and tolerability of MK-7684A alone or in combination with other anticancer therapies.
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors: • Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix • Endometrial cancer • Head and neck squamous cell carcinoma (HNSCC) • Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma) • Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ). • Triple-negative breast cancer (TNBC) • Hepatocellular carcinoma (HCC) • Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra • Ovarian cancer • Gastric cancer
- Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator
- Adequately controlled blood pressure (BP) with or without antihypertensive medications
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
- Male participants must agree to follow contraceptive guidance
- Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance
- Adequate organ function
Exclusion criteria 11
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent
- Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
- Active autoimmune disease that has required systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Concurrent active hepatitis B and hepatitis C virus infection
- History of allogenic tissue/solid organ transplant
- Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm)
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
- Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
- ORR per RECIST 1.1 as Assessed by Investigator
- PFS per RECIST 1.1 as Assessed by Investigator at 9 months
- PFS per RECIST 1.1 as Assessed by Investigator at 12 months
Secondary endpoints 8
- Overall Survival (OS)
- PFS per RECIST 1.1 as Assessed by Investigator
- Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
- DOR per RECIST 1.1 as Assessed by Investigator
- ORR per RECIST 1.1 as Assessed by Investigator
- Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30)
- Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)
- Number of Participants Who Experienced One or More Adverse Events (AEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD9386962 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 14000 mg milligram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414231 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 4900 mg milligram(s)
- Max treatment duration
- 245 Day(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
- 20 mg milligram(s)
- Max total dose
- 4900 mg milligram(s)
- Max treatment duration
- 245 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
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
- 200 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 9
SCP126226 · ATC
- Active substance
- Docetaxel
- Substance synonyms
- DOCETAXEL ANHYDROUS
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 375 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP29096188 · ATC
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 225 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 45 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — BEVACIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1128788 · ATC
- Active substance
- Gemcitabine Hydrochloride
- Substance synonyms
- 4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 70000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 4500 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 480 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1160311 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 800 mg/m2 milligram(s)/sq. meter
- Max total dose
- 140000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 130 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4550 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129816 · ATC
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 175 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 140 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP131876 · ATC
- Active substance
- Capecitabine
- Route of administration
- ORAL USE
- Max daily dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 980000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 105 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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
- Robert GraigCastellino
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Robert GraigCastellino
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Fortrea Inc. ORG-100012602
|
Princeton, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| PRA International ORG-100032850
|
Blue Bell, United States | Other |
Locations
6 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 58 | 6 |
| Germany | Ended | 29 | 4 |
| Italy | Ended | 19 | 4 |
| Netherlands | Ended | 15 | 2 |
| Poland | Ended | 61 | 3 |
| Spain | Ended | 46 | 4 |
| Rest of world
United States, Canada, Colombia, Chile, Japan, Israel, Korea, Republic of, Taiwan, Turkey
|
— | 410 | — |
Investigational sites
Centre Leon Berard
Service d’Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Sainte Catherine Institut Du Cancer Avignon-Provence
Service d’Oncologie Médicale, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Institut Gustave Roussy
Département de Médecine, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Regional Du Cancer De Montpellier
Service d’Oncologie Médicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Curie
Centre d’Investigation Clinique- D3I, 26 Rue D Ulm, 75005, Paris
Centr Georges Francois Leclerc
Service d’Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Universitaetsklinikum Duesseldorf AöR
Klinik für Gastroenterologie, Hepatologie und Infektiologie, Moorenstrasse 5, Bilk, Duesseldorf
Charite Universitaetsmedizin Berlin KöR
Charité Benjamin Franklin Onkologische Studienzentrale Bettenhaus 5, Etage 2, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Heidelberg AöR
Frauenheilkunde und Geburtshilfe, Sektion Gynäkologische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Humanitas Mirasole S.p.A.
U.O di Oncologia medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni Cliniche S.C di Oncologia Medica Senologica, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Ginecologia Oncologica, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badan Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddzial Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| France | 2021-11-24 | 2025-06-26 | 2021-11-25 | 2024-07-19 | |
| Germany | 2021-12-10 | 2022-03-02 | 2024-07-19 | ||
| Italy | 2021-12-10 | 2022-01-04 | 2024-07-19 | ||
| Netherlands | 2021-11-25 | 2025-02-17 | 2021-12-10 | 2024-07-19 | |
| Poland | 2021-09-13 | 2025-06-27 | 2021-09-16 | 2024-07-19 | |
| Spain | 2021-09-22 | 2025-02-03 | 2021-09-27 | 2024-07-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-64584
- Event date
- 2024-12-16
- Submission date
- 2024-12-20
- In response to
- OTHER
- Member states affected
- France, Germany, Italy, Spain, Netherlands, Poland
- Event description
- KEYVIBE-005: A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (NCT05007106, EU CT 2021-001009-56).
In a pre-planned analysis for KeyVibe-003 and KeyVibe-007 studies, both trials met the pre-specified futility criteria for the primary endpoint of overall survival. In these studies, the safety profile of the fixed-dose combination was consistent with that observed for vibostolimab (MK-7684) and pembrolizumab in previously reported studies, with no new safety signals identified. Based on the lack of efficacy in KeyVibe-003, KeyVibe-007, the previously announced Phase 3 studies, KeyVibe-010 in adjuvant melanoma and KeyVibe-008 in extensive-stage small cell lung cancer, and following the recommendations from the external Data Monitoring Committee (eDMC) to unblind the KeyVibe-003 and KeyVibe-007, crossover all patients receiving MK-7684A to pembrolizumab, and perform no additional analyses for the OS endpoint and secondary endpoints, MSD has decided to discontinue MK-7684/MK-7684A in all studies, including KEYVIBE-005. This decision is not based on any concerns about the safety of MK-7684/MK-7684A. - Measures taken
- There are currently 38 patients who are being treated with MK-7684A on the KEYVIBE-005 study.
The Sponsor issued a Communication to Investigator Letter on December 16, 2024, which is attached, requiring the following actions by investigator and site personnel:
1. All study participants receiving treatment with vibostolimab/pembrolizumab (MK-7684A) should stop treatment with this coformulation and be offered pembrolizumab monotherapy .
2. The participants should be informed within 4 weeks of receiving Communication to Investigator Letter and communication with the participants should be documented in their medical records.
3. Because participants in KEYVIBE-005 will be offered to switch to pembrolizumab monotherapy or in combination with chemotherapy, where applicable (which may be sourced locally from commercial stock in respective countries if needed until available through central sourcing) and as of the event date (i.e. immediate implementation required), this event is considered as an Urgent Safety Measure (USM).
4. The MK-7684A arms will remain open so that remaining participants on treatment will have continued access to pembrolizumab.
5. Data collection will be limited: response data will no longer be collected though documentation of AEs should remain uninterrupted. The study will close once all participants are no longer on study treatment.
6. The final visit in the KEYVIBE-005 study will be the Safety Follow-up Visit. There will be no follow-up for survival status. Participants currently in imaging follow-up or in survival follow-up are considered to have completed the study and therefore should obtain imaging and further oncological care as per local standard of care. However, standard safety reporting should continue, as applicable.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 57 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-505284-36_SM08_for pub | 12R |
| Protocol (for publication) | D4_Subject questionnaire_EN_2023-505284-36-00_for pub | 1R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure LT FU_FRA_FR_for pub | 02NOV2021 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | 22MAR2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 20FEB2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_for pub | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_for pub | 11JUN2021R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ESP_ES_for pub | v2R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FRA_FR_for pub | 28JUN2021R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Subject Recruitment_NLD_NL_for pub | v3 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_ES_for pub | v.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ITA_IT_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_NLD_NL_for pub | v00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum trial closing_FRA_FR_SM08-RFI002_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Cohorts ABCD2EGIJ_FRA_FR_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_for pub | AM02v2.04 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Trial Closing_POL_PL_SM08_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_cohort B_FRA_FR_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_cohort D2_FRA_FR_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_cohort E_FRA_FR_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_cohort G_FRA_FR_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_Cohort I_FRA_FR_SM08-RFI002_for pub_ | AM04v4-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_cohort J_FRA_FR_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_cohorts ACD1H_FRA_FR_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_for pub | AM02v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_for pub | v2.04R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_for pub | AM02v2.04 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_for pub | AM02v2.04R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM08_for pub | AM05v5.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_for pub | 04MAR2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_DE_for pub | v0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_addendum_progression consent_DEU_DE_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_addendum_progression consent_FRA_FR_for pub | AM02v2.04 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_for pub | 04MAR2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner data privacy_ITA_IT_for pub | 04MAR2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_for pub | v.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ITA_IT_for pub | 04MAR2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_prescreening_DEU_DE_for pub | v0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tissue sample_NLD_NL_for pub | v00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tumor screening_ESP_ES_for pub | v.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tumor screening_FRA_FR_for pub | AM02v2.04 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tumor screening_ITA_IT_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tumor screening_POL_PL_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_Patient visit scheme_A1A2B1CD1EFHJ_NLD_NL_for pub | v1.0 |
| Subject information and informed consent form (for publication) | L1_Patient visit scheme_B2G_NLD_NL_for pub | v1.0 |
| Subject information and informed consent form (for publication) | L1_Patient visit scheme_D2_NLD_NL_for pub | v1.0 |
| Subject information and informed consent form (for publication) | L1_Patient visit scheme_I_NLD_NL_for pub | v1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-505284-36_ESP_ES_SM08_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-505284-36_FRA_FR_SM08_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-505284-36_ITA_IT_TC_not pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-505284-36_NLD_NL_SM08_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-505284-36_POL_PL_SM08_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-505284-36_SM08_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-505284-36_DEU_DE_TC_not pub | AM10 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-505284-36_for pub | 09 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | Netherlands | Acceptable 2024-02-06
|
2024-02-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-25 | Netherlands | Acceptable 2024-05-27
|
2024-05-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-25 | Acceptable 2024-05-27
|
2024-06-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-24 | Netherlands | Acceptable 2024-10-25
|
2024-10-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-21 | Netherlands | Acceptable 2025-04-17
|
2025-04-18 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-01 | Netherlands | Acceptable 2025-04-17
|
2025-07-01 |