Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
809
Countries
8
Sites
23
Endometrial Cancer
To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) by assessment of progression free survival (PFS), in patients w…
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Aug 2020 → ongoing
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB, Sweden
External identifiers
- EU CT number
- 2022-502746-27-00
- EudraCT number
- 2019-004112-60
- ClinicalTrials.gov
- NCT04269200
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Pharmacogenomic, Pharmacodynamic, Efficacy, Therapy
To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) by assessment of progression free survival (PFS), in patients with newly diagnosed advanced or recurrent endometrial cancer
Secondary objectives 4
- To determine the efficacy of durvalumab in combination with platinumbased chemotherapy followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of: PFS2, OS, ORR, DoR, TFST, TSST and TDT.
- To characterise the PK and immunogenicity of durvalumab and durvalumab in combination with olaparib.
- To evaluate the safety and tolerability of durvalumab in combination with platinum-based chemotherapy followed by maintenance durvalumab or durvalumab with olaparib compared to platinum-based chemotherapy alone.
- To determine effects on symptoms, functioning and overall healthrelated quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone.
Conditions and MedDRA coding
Endometrial Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10007342 | Carcinoma endometrial | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study Approximately 699 patients will be randomised in a 1:1:1 ratio to the study treatments specified below (N=233 patients per arm).
|
Randomised Controlled | Double | [{"id":161820,"code":3,"name":"Monitor"},{"id":161823,"code":1,"name":"Subject"},{"id":161824,"code":5,"name":"Carer"},{"id":161822,"code":4,"name":"Analyst"},{"id":161821,"code":2,"name":"Investigator"}] | Arm A (control): Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets). Arm B (durvalumab+placebo): Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo Arm C (durvalumab+olaparib): Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib. |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥18 years at the time of screening and female.
- Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
- Patient must have endometrial cancer in one of the following categories: a) Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), b) Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) c) Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
- Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting (as part of the upfront/adjuvant anti-cancer treatment, which may be concurrent or followed with chemoradiation) and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse.
- FPPE tumor sample must be available for MMR evaluation.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.
Exclusion criteria 4
- History of leptomeningeal carcinomatosis
- Brain metastases or spinal cord compression.
- Prior treatment with PARP inhibitors.
- Prior immune-mediated therapy including other anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines"
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS (per RECIST 1.1 as assessed by investigator) is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression).
Secondary endpoints 10
- PFS2: Second progression-free survival is defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause.
- OS: Overall survival is defined as the time from the date of randomisation until death due to any cause.
- ORR: Objective response rate is the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR), as determined by the investigator at local site.
- DoR: Duration of response is time from the date of first documented response (subsequently confirmed) until date of documented progression or death in the absence of disease progression, as determined by the investigator at local site.
- TFST: Time to first subsequent therapy or death is time from randomisation to the earlier of start date of the first subsequent anticancer therapy after discontinuation of randomised treatment or death due to any cause.
- TSST: Time to second subsequent therapy or death is time from randomisation to the earlier of start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment or death due to any cause.
- TDT: Time to study treatment discontinuation or death is time from randomisation to the earlier of the date of study treatment discontinuation or death.
- Serum concentrations of durvalumab
- Anti-drug antibodies (ADA) to durvalumab
- Safety and tolerability will be evaluated in terms of AEs/serious AEs (SAEs), physical examination, vital signs including blood pressure, pulse, clinical laboratory including clinical chemistry/haematology parameters, and ECG
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651402 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 142 g gram(s)
- Max treatment duration
- 360 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lynparza 150 mg film-coated tablets
PRD6152224 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1514 g gram(s)
- Max treatment duration
- 360 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lynparza 150 mg film coated Tablet is identical to the IMP except that it has a commercial deboss/marking. The IMP is unmarked and packed in HDPE bottles rather than the commercial blister pack to facilitate blinding in placebo controlled studies.
Lynparza 100 mg film-coated tablets
PRD6163466 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1514 g gram(s)
- Max treatment duration
- 360 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lynparza 100 mg film coated Tablet is identical to the olaparib 100mg tablet (IMP) except that that it has a yellow film coat due to the deletion of a small amount of black iron oxide, and has a commercial deboss/marking. The IMP has a green film coat, is unmarked and packed in HDPE bottles rather than the commercial blister pack to facilitate blinding in placebo controlled studies.
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Lynparza 100 mg, Lynparza 150 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 9
PRD3925410 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/07/438/002
- MA holder
- TEVA B.V
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
PRD8167805 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/07/438/009
- MA holder
- TEVA B.V
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
PRD3932635 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/07/438/006
- MA holder
- TEVA B.V
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
PRD3925409 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/07/438/001
- MA holder
- TEVA B.V
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
Flixabi 100 mg powder for concentrate for solution for infusion
PRD4101383 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 210 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/16/1106/001
- MA holder
- SAMSUNG BIOEPIS NL B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
Flixabi 100 mg powder for concentrate for solution for infusion
PRD4252072 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 210 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/16/1106/003
- MA holder
- SAMSUNG BIOEPIS NL B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
Flixabi 100 mg powder for concentrate for solution for infusion
PRD4252071 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 210 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/16/1106/002
- MA holder
- SAMSUNG BIOEPIS NL B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
Flixabi 100 mg powder for concentrate for solution for infusion
PRD4252073 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 210 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/16/1106/004
- MA holder
- SAMSUNG BIOEPIS NL B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
Flixabi 100 mg powder for concentrate for solution for infusion
PRD4252074 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 210 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/16/1106/005
- MA holder
- SAMSUNG BIOEPIS NL B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original commercial packaging will be over-labelled and placed in a carton which will also be over-labelled with local language translated text in accordance with regulatory guidelines.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Code 2, Laboratory analysis, Code 5, E-data capture, Code 8, Code 9 |
Locations
8 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 28 | 6 |
| Estonia | Ongoing, recruitment ended | 4 | 1 |
| Germany | Ongoing, recruitment ended | 4 | 1 |
| Greece | Ongoing, recruitment ended | 22 | 2 |
| Hungary | Ongoing, recruitment ended | 13 | 3 |
| Lithuania | Ongoing, recruitment ended | 9 | 1 |
| Poland | Ongoing, recruitment ended | 20 | 5 |
| Spain | Ongoing, recruitment ended | 16 | 4 |
| Rest of world
Korea, Republic of, Japan, China, Israel, Canada, Russian Federation, Mexico, Singapore, United States, Colombia, Hong Kong, Australia, Brazil
|
— | 693 | — |
Investigational sites
Hopital De Libramont
Medical Oncology, Avenue De Houffalize 35, 6800, Libramont-Chevigny
Algemeen Ziekenhuis Groeninge
Medical Oncology, President Kennedylaan 4, 8500, Kortrijk
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Jessa Ziekenhuis
Medical Oncology, Stadsomvaart 11, 3500, Hasselt
UZ Leuven
Medical Oncology, Herestraat 49, 3000, Leuven
CHC MontLegia
Medical Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Tartu University Hospital
Oncology, L. Puusepa Tn 1a, 50406, Tartu Linn
Alexandra Hospital
Department of Clinical Therapeutics, Oncology-Hematology Unit, Vassilissas Sofias Avenue 80, 115 28, Athens
Areteio Hospital
Oncology Unit, Β’ Surgical Clinic, Vassilissas Sofias Avenue 76, 115 28, Athens
Orszagos Onkologiai Intezet
Nőgyógyászati Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Onkoradiológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Budapesti Uzsoki Utcai Korhaz
Onkoradiológiai Osztály, Uzsoki Utca 29-41, 1145, Budapest XIV
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Center of Hematology, Oncology and Transfusion Medicine, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej, Al. Wojska Polskiego 37, 10-228, Olsztyn
Uniwersyteckie Centrum Kliniczne
Klinika Ginekologii, Oddział Onkologii G, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
I Klinika Ginekologii Onkologicznej i Ginekologii, Ul. Aleja Solidarnosci 8, 20-841, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Chemioterapii Nowotworów z Pododdziałem Chemioterapii Jednego Dnia, Ul. Pabianicka 62, 93-513, Lodz
Umed Clinical Trials Sp. z o.o.
NA, Bud A-2, Ul. Pomorska 251, Lodz
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
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 |
|---|---|---|---|---|---|
| Belgium | 2020-08-21 | 2020-08-21 | 2023-06-08 | ||
| Estonia | 2021-11-17 | 2021-11-17 | 2023-06-08 | ||
| Germany | 2021-05-19 | 2021-05-19 | 2023-06-08 | ||
| Greece | 2020-09-28 | 2020-09-28 | 2023-06-08 | ||
| Hungary | 2020-12-30 | 2020-12-30 | 2023-06-08 | ||
| Lithuania | 2021-03-29 | 2021-03-29 | 2023-06-08 | ||
| Poland | 2020-09-07 | 2020-09-07 | 2023-06-08 | ||
| Spain | 2021-11-24 | 2021-11-24 | 2023-06-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 64 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502746-27-00 redacted | 6.0 |
| Protocol (for publication) | D1_Protocol_2022-502746-27-00_GR_redacted | 6.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | NA |
| Subject information and informed consent form (for publication) | L1_COVID addendum ICF_HU | 1.0 |
| Subject information and informed consent form (for publication) | L1_COVID addendum PIS_HU | 1.0 |
| Subject information and informed consent form (for publication) | L1_COVID ICF addendum EST | 1.0 |
| Subject information and informed consent form (for publication) | L1_COVID ICF addendum_EST_RU | 1.0 |
| Subject information and informed consent form (for publication) | L1_COVID ICF addendum_LT | 1.0 |
| Subject information and informed consent form (for publication) | L1_COVID ICF addendum_LT-RU | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF EST_Redacted | 17.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF EST_RU_Redacted | 17.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_HU_Redacted | 16.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_LT_Redacted | 12.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_LT-RU_Redacted | 12.0 |
| Subject information and informed consent form (for publication) | L1_Main PIS_Redacted_HU | 15.0 |
| Subject information and informed consent form (for publication) | L1_Optional Genetic ICF_HU | 2.0 |
| Subject information and informed consent form (for publication) | L1_Optional Genetic PIS_HU | 2.0 |
| Subject information and informed consent form (for publication) | L1_Prescreen ICF_HU | 2.0 |
| Subject information and informed consent form (for publication) | L1_Prescreen PIS_Redacted_HU | 2.0 |
| Subject information and informed consent form (for publication) | L1_Prescreening ICF EST_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Prescreening ICF LT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Prescreening ICF_EST_RU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Prescreening ICF_LT-RU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Addendum COVID_BE_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Addendum COVID_BE_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Addendum COVID_BE_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and COVID ICF addendum_GRE | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and COVID_addendum_DE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID addendum_ES | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_ES | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_DE_Redacted | 16.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_ES_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_ENG_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_FR_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_NL_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_DE_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_ES_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID Addendum_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screen_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF_GRE_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and Optional Genetic ICF_GRE | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and pre-screening ICF_BE_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and pre-screening ICF_BE_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and pre-screening ICF_BE_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Pre-Screening ICF_GRE_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_BE-DE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_BE-Dutch | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_BE-FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_ES | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_GR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_HU | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_LT | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-502746-27-00_PL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_Redacted | 6.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-25 | Belgium | Acceptable with conditions 2024-08-21
|
2024-08-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-23 | Belgium | Acceptable with conditions 2025-04-07
|
2025-04-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-02 | Belgium | Acceptable 2025-09-01
|
2025-09-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-22 | Belgium | Acceptable 2025-09-01
|
2025-09-22 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-24 | Acceptable | 2025-11-05 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-11 | Belgium | Acceptable | 2025-12-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-11 | Acceptable | 2026-01-05 |