Informations générales (source: ClinicalTrials.gov)
Randomized Phase II Study Comparing Neo-epitope Based Vaccine OSE2101 (TEDOPI®) With or Without Anti-PD1 (Pembrolizumab) Versus Best Supportive Care as Maintenance Treatment in Platinum-sensitive Recurrent Ovarian Cancer Patient With Controlled Disease After Platinum-based Chemotherapy
Interventional
Phase 2
ARCAGY/ GINECO GROUP (Voir sur ClinicalTrials)
août 2021
décembre 2025
26 août 2025
The proposed study is an international randomized phase II, multicenter, open-label,
three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 +
pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed
ovarian cancers, previously treated with chemotherapy (regardless of the number of prior
lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if
eligible).
Patients in Complete Response, Partial Response, or Stable Disease at the end of
chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in
one of the three arms (randomization 1:1:2). They will receive one or the two study
treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study
treatment dose).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 23/05/2024 08:43:29 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Center Hospitalier de Pau - 64000 - Pau - France | Contact (sur clinicalTrials) | ||||
| Centre CARIO - HPCA - 22190 - Plérin - France | Contact (sur clinicalTrials) | ||||
| Centre d'Oncologie et de Radiothérapie 37 - 37170 - Chambray-lès-Tours - France | Contact (sur clinicalTrials) | ||||
| Centre Eugène Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Broussais - 35400 - Saint-Malo - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Cholet - 49300 - Cholet - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64109 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - 69495 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Centre Jean PERRIN - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon - Hôpital Jean Minjoz - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint-Etienne - Pôle de Cancérologie - 42271 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble-Alpes - Site Nord (La Tronche) - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - Dupuytren - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Diaconesses-Croix Saint-Simon - 75020 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pitié-Salpêtrière - AP-HP - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé du Confluent - 44202 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé Jean Mermoz - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| ICM - Val d'Aurelle - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| ICO - Centre René Gauducheau - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| ICO Paul Papin - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Régaud - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Strasbourg Europe - ICANS - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut du Cancer Avignon-Provence - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
1. Signed and dated informed consent document for the study, willing and able to comply
with protocol requirements, including:
1. HLA-A2 phenotype determination by genetic test (blood)
2. participation in translational research in HLA-A2 positive
3. authorization for long term follow up if HLA-A2 negative
2. Histologically proven non-mucinous epithelial ovarian cancer
3. Positive HLA-A2 phenotype
4. Age ≥ 18 years
5. ECOG Performance Status (PS) 0-1
6. Clinical or radiological relapse of a platinum sensitive ovarian cancer regardless
of the number of prior lines of platinum-based chemotherapy, as long as each prior
line fulfilled the platinum sensitive criteria defined as complete response, partial
response or stable disease according to RECIST 1.1 at the end of a platinum-based
chemotherapy. Patient must have received at least 4 infusions of platinum during the
last line of platinum-based chemotherapy
7. Previously treated with a PARP inhibitor or not eligible to PARPi (i.e ineligibility
due to not complete or partial response to chemotherapy)
8. Prior therapy with bevacizumab or with contra-indication to bevacizumab (i.e
arterial thromboembolic events, history of intestinal perforation, any other
contra-indications according to the SmPC)
9. Patient may have received prior immune checkpoint inhibitor (ICI), such as
anti-PD-(L)1 or anti-CTLA-4 antibody and had a relapse after receiving the ICI
without concomitant chemotherapy for at least 6 months (as treatment or maintenance)
10. Randomization must be within 8 weeks of last dose of chemotherapy
11. Adequate organ function Adequate marrow function White blood cell (WBC) ≥ 3000/ mm3
Neutrophils ≥ 1500/ mm3 Platelets ≥ 100 × 103/mm3 (in the absence of transfusion
within 2 weeks from before randomization) Haemoglobin ≥ 9 g/dL (in the absence of
transfusion within 2 weeks from before randomization) Adequate other organ functions
ALT and AST ≤ 2.5 × ULN, unless liver metastases are presents in which case they
must be ≤ 5.0 × ULN Total bilirubin ≤ 1.5× ULN (except Gilbert Syndrome: < 3.0
mg/dL)
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min (measured
using the Cockcroft-Gault formula below):
Female CrCl = (140 - age in years) × weight in kg × 0.85 72 × serum creatinine in
mg/dL
12. Archival or fresh (if possible) tumor tissue must be available for evaluating
relevant biomarkers.
13. Women of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to treatment allocation, and have to use of highly effective
contraception during the treatment period and for at least 180 days after the last
dose of study treatment
14. Stated willingness to comply with all study procedures and availability for the
duration of the study
15. For countries where this will apply to : a subject will be eligible for
randomization in this study only if either affiliated to, or a beneficiary of, a
social security category.
1. Signed and dated informed consent document for the study, willing and able to comply
with protocol requirements, including:
1. HLA-A2 phenotype determination by genetic test (blood)
2. participation in translational research in HLA-A2 positive
3. authorization for long term follow up if HLA-A2 negative
2. Histologically proven non-mucinous epithelial ovarian cancer
3. Positive HLA-A2 phenotype
4. Age ≥ 18 years
5. ECOG Performance Status (PS) 0-1
6. Clinical or radiological relapse of a platinum sensitive ovarian cancer regardless
of the number of prior lines of platinum-based chemotherapy, as long as each prior
line fulfilled the platinum sensitive criteria defined as complete response, partial
response or stable disease according to RECIST 1.1 at the end of a platinum-based
chemotherapy. Patient must have received at least 4 infusions of platinum during the
last line of platinum-based chemotherapy
7. Previously treated with a PARP inhibitor or not eligible to PARPi (i.e ineligibility
due to not complete or partial response to chemotherapy)
8. Prior therapy with bevacizumab or with contra-indication to bevacizumab (i.e
arterial thromboembolic events, history of intestinal perforation, any other
contra-indications according to the SmPC)
9. Patient may have received prior immune checkpoint inhibitor (ICI), such as
anti-PD-(L)1 or anti-CTLA-4 antibody and had a relapse after receiving the ICI
without concomitant chemotherapy for at least 6 months (as treatment or maintenance)
10. Randomization must be within 8 weeks of last dose of chemotherapy
11. Adequate organ function Adequate marrow function White blood cell (WBC) ≥ 3000/ mm3
Neutrophils ≥ 1500/ mm3 Platelets ≥ 100 × 103/mm3 (in the absence of transfusion
within 2 weeks from before randomization) Haemoglobin ≥ 9 g/dL (in the absence of
transfusion within 2 weeks from before randomization) Adequate other organ functions
ALT and AST ≤ 2.5 × ULN, unless liver metastases are presents in which case they
must be ≤ 5.0 × ULN Total bilirubin ≤ 1.5× ULN (except Gilbert Syndrome: < 3.0
mg/dL)
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min (measured
using the Cockcroft-Gault formula below):
Female CrCl = (140 - age in years) × weight in kg × 0.85 72 × serum creatinine in
mg/dL
12. Archival or fresh (if possible) tumor tissue must be available for evaluating
relevant biomarkers.
13. Women of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to treatment allocation, and have to use of highly effective
contraception during the treatment period and for at least 180 days after the last
dose of study treatment
14. Stated willingness to comply with all study procedures and availability for the
duration of the study
15. For countries where this will apply to : a subject will be eligible for
randomization in this study only if either affiliated to, or a beneficiary of, a
social security category.
1. Patient with contra-indications to immune therapies
2. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be
scheduled to continue concomitantly to the study)
3. Use of any of the following immunomodulatory agents within 30 days prior to the
first dose of study drug: Systemic corticosteroids (at dose higher than 10 mg/day
equivalent prednisone); if systemic corticoid use, corticoid must be stopped at
least 7 days before study treatment start Interferons Interleukins Live vaccine
Note: Examples of live vaccines include, but are not limited to, the following:
measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid
vaccine. Seasonal influenza vaccines for injection are generally killed virus
vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior
the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®)
are live attenuated vaccines and are not allowed.
4. Prior cancer vaccine therapy
5. Patient eligible for cytoreductive surgery at the time of inclusion
6. Patient with clinical, radiological or biological progression (according GCIG
criteria) at the end of last chemotherapy
7. Prior radiotherapy within 2 weeks of start of study intervention. Participants must
have recovered from all radiation-related toxicities, not require corticosteroids,
and not have had radiation pneumonitis.
A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to
non-CNS disease.
8. Patient with active autoimmune disease that has required systemic treatment in the
past 2 years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
9. History of serious adverse reactions, including anaphylaxis and related symptoms
such as hives and respiratory difficulty following administration of any vaccines,
or a history of hypersensitivity, specifically to any components of study vaccine
10. Prior history of other malignancies other than study disease (except for basal cell
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other
in situ cancer considered as cured) unless the patient has been free of the disease
for at least 5 years.
11. Immune-deficient status (patients with HIV, immunosuppressive treatment,
haematological malignancies, and previous organ transplantation)
12. History of (non-infectious) pneumonitis / interstitial lung disease that required
steroids or has current pneumonitis / interstitial lung disease that requires
steroids.
13. History of any chronic hepatitis as evidenced by:
Positive test for hepatitis B surface antigen Positive test for qualitative
hepatitis C viral load (by polymerase chain reaction [PCR]) Note: Subjects with
positive hepatitis C antibody and negative quantitative hepatitis C by PCR are
eligible. History of resolved hepatitis A virus infection is not an exclusion
criterion
14. Uncontrolled or significant cardiovascular disease including, but not limited to,
any of the following: Myocardial infarction or stroke/transient ischemic attack
within the past 6 months Uncontrolled angina within the past 3 months History of
other clinically significant heart disease (eg, cardiomyopathy, congestive heart
failure with New York Heart Association functional classification III-IV,
pericarditis, significant pericardial effusion, or myocarditis) Any history of
clinically significant arrhythmias (such as ventricular tachycardia, ventricular
fibrillation, or torsades de pointes) QT interval corrected for heart rate using
Fridericia's formula (QTcF) prolongation > 480 msec Cardiovascular disease-related
requirement for daily supplemental oxygen therapy
15. Subjects with known or suspected CNS metastases, untreated CNS metastases, are
excluded. However, subjects with controlled brain metastases will be allowed to
enroll. Controlled brain metastases are defined as no radiographic progression for
at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of
observation if no intervention is clinically indicated), and off of steroids for at
least 2 weeks, and no new or progressive neurological signs and symptoms.
16. Any major surgery within 4 weeks of study drug administration. Subjects must have
recovered from the effects of major surgery or significant traumatic injury at least
14 days before date of randomization.
17. Patients who has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or
any of its excipients (refer to the IB for a list of excipients).
18. Patients who has an active infection requiring systemic therapy.
19. Any acute medical condition that in the opinion of the investigator may obscure the
ability to observe the safety or activity of the study vaccine treatment
20. Any mental or psychiatric condition that, in the opinion of the investigator, is
likely to compromise the ability to adhere to the protocol schedule
21. Life expectancy of less than 12 weeks
22. Pregnant or breastfeeding women
23. Concurrent participation in any other investigational study