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Platinum-sensitive Ovarian CancerPhase 2TEDOVANCT04713514

OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

A Phase 2 study testing OSE2101 and Pembrolizumab 25 MG/ML [Keytruda] in people with Platinum-sensitive Ovarian Cancer and Relapsed Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 41 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
OSE2101 and Pembrolizumab 25 MG/ML [Keytruda]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
41 sitesin 3 countries
Study dates
5 Aug 2021to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent document for the study, willing and able to comply with protocol requirements, including:
  • HLA-A2 phenotype determination by genetic test (blood)
  • participation in translational research in HLA-A2 positive
  • authorization for long term follow up if HLA-A2 negative
  • Histologically proven non-mucinous epithelial ovarian cancer
  • Positive HLA-A2 phenotype
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  • Age ≥ 18 years
  • ECOG Performance Status (PS) 0-1
  • 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
  • Previously treated with a PARP inhibitor or not eligible to PARPi (i.e ineligibility due to not complete or partial response to chemotherapy)
  • 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)
  • 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)
  • Randomization must be within 8 weeks of last dose of chemotherapy
  • 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
  • Archival or fresh (if possible) tumor tissue must be available for evaluating relevant biomarkers.
  • 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
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • 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.

Who cannot join

  • Patient with contra-indications to immune therapies
  • Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study)
  • 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.
  • Prior cancer vaccine therapy
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  • Patient eligible for cytoreductive surgery at the time of inclusion
  • Patient with clinical, radiological or biological progression (according GCIG criteria) at the end of last chemotherapy
  • 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.
  • 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.
  • 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
  • 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.
  • Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation)
  • History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease that requires steroids.
  • 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
  • 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
  • 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.
  • 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.
  • 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).
  • Patients who has an active infection requiring systemic therapy.
  • 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
  • Any mental or psychiatric condition that, in the opinion of the investigator, is likely to compromise the ability to adhere to the protocol schedule
  • Life expectancy of less than 12 weeks
  • Pregnant or breastfeeding women
  • Concurrent participation in any other investigational study

Trial locations and contacts

41 sites in 3 countries.

41 sites in 3 countries

France32 sites

  • ICO Paul Papin

    Angers, 49055

  • Institut du Cancer Avignon-Provence

    Avignon, 84000

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14000

  • Centre d'Oncologie et de Radiothérapie 37

    Chambray-lès-Tours, 37170

  • Centre Hospitalier de Cholet

    Cholet, 49300

  • Centre Jean PERRIN

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21000

  • CHU Grenoble-Alpes - Site Nord (La Tronche)

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • CHU Limoges - Dupuytren

    Limoges, 87042

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • ICM - Val d'Aurelle

    Montpellier, 34298

  • Hôpital Privé du Confluent

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06100

  • Hôpital Pitié-Salpêtrière - AP-HP

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Groupe Hospitalier Diaconesses-Croix Saint-Simon

    Paris, 75020

  • Center Hospitalier de Pau

    Pau, 64000

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre CARIO - HPCA

    Plérin, 22190

  • Centre Eugène Marquis

    Rennes, 35042

  • ICO - Centre René Gauducheau

    Saint-Herblain, 44805

  • CHU de Saint-Etienne - Pôle de Cancérologie

    Saint-Priest-en-Jarez, 42271

  • Centre Hospitalier Broussais

    St-Malo, 35400

  • CHU Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200

  • Institut Claudius Régaud

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany6 sites

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Evang. Kliniken Essen-Mitte GmbH

    Essen, 45136

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Universitätsmedizin Mannheim GmbH

    Mannheim, 68167

  • Universitätsklinikum Ulm

    Ulm, 89075

Other trials in Germany

Belgium3 sites

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier de l'Ardenne Vivalia

    Libramont, 6800

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

About this study

Official title: 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

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).

Read the detailed description

The only therapeutic option for ovarian cancer patients presenting platinum sensitive relapse post- both bevacizumab and a PARPi is a platinum combination x 6 cycles followed by observation. There is no currently approved maintenance therapy in this setting. There is an urgent need for novel strategies for OC in relapse post bevacizumab and PARPi, in particular for novel maintenance strategies to prolong chemotherapy-free intervals.

One attractive strategy to turn OC from 'cold' tumors into a 'hot' tumor is via vaccination with tumor associated, or specific epitopes that have been modified to increase MHC and TCR binding.

OSE2101 is a multi-neoepitope vaccine covering relevant TAAs in OC, including p53 (mutated in 95% of high-grade OC). In addition, the combination of OSE2101with an ICI may most effectively harness anti-tumor immunity.

If novel IO approaches are proposed in OC, they should be investigated early in the disease setting when host immunity is still robust, and with low tumor burden (platinum sensitive relapse and after 6 cycles of platinum chemotherapy).

The hypothesis being tested is that OSE2101 alone or in combination with Pembrolizumab as maintenance treatment in patients with ovarian cancer platinum-sensitive relapse could potentially bring benefit to subjects with high unmet medical need.

A total of 180 patients with HLA-A2 positive phenotype will be randomized using an Interactive Web Response System (IWRS) according to the following stratification factor:

  • Best response to platinum therapy: SD vs PR/CR

In a 1:1:2 ration on the 3 study arms:

  • Arm A (n=45): Observation/best supportive care
  • Arm B (n=45): OSE2101: every 3 weeks until week 18, then every 6 weeks up to week 48, then every 12 weeks until disease progression, intolerance, patient withdrawal of consent or up to 2 years
  • Arm C (n=90): OSE2101 + Pembrolizumab: OSE2101 same schedule as arm B plus pembrolizumab IV every 6 weeks until disease progression, intolerance, patient withdrawal of consent or up to 2 years

Patient with phenotype HLA-A2 negative will be followed in a separate cohort to record treatment and outcomes.

Being tested
OSE2101, Pembrolizumab 25 MG/ML [Keytruda]
Keywords
Maintenance therapy, Immunotherapy, Cancer vaccine, Cold tumor, Relapse, Pembrolizumab, TEDOPI
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSE2101Drug

    Also called TEDOPI®

    subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years.

  • Pembrolizumab 25 MG/ML [Keytruda]Drug

    Also called KEYTRUDA®, MK-3475

    400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.

Study groups in NCT04713514
Study groupRoleWhat they receive
Arm A : Best Supportive CareNo interventionObservational arm (Standard of care)
Arm B : OSE2101ExperimentalOSE2101 monotherapy - subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years. OSE2101 vaccine is an emulsion of peptides suspension in in Montanide® ISA 51 adjuvant and containing 0.5 mg/mL of each 10 synthetically manufactured peptides (5.0 mg/mL total peptide) in 1.5 mL of emulsion.
Receives: Drug: OSE2101
Arm C : OSE2101 + PembrolizumabExperimentalOSE2101 (subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years) + pembrolizumab (400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.
Receives: Drug: OSE2101; Drug: Pembrolizumab 25 MG/ML [Keytruda]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Progression-free survival (PFS) is the time from randomization to progression measured radiologically using RECIST v1.1 guidelines as reported by the investigator or death, whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date

    Measured: from date to randomization to date of event, assessed up to 4 years

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Objective response rate is defined using RECIST v1.1. Best overall response is defined as the best radiological response observed over the whole evaluation period before progression or subsequent anti-cancer treatment. Proportion of partial and complete responses over the treated population will be computed.

    Measured: from date to randomization to date of event, assessed up to 4 years

  2. Incidence of treatment emergent adverse events

    Incidence of treatment emergent adverse events will be assessed based on NCI CTC-AE version 5.0 grade and according MedDRA terms (version 23.0)

    Measured: from date to randomization to date of study end, assessed up to 4 years

  3. Time to subsequent first treatments (TTST-1)

    Time to subsequent treatment (TTST) is the time from randomization to initiation of a first subsequent treatment (including treatment change due to toxicity or investigator's decision). Deaths will be counted as events. Patients alive and not receiving a subsequent treatment will be censored at the last assessment date.

    Measured: from date to randomization to date of event, assessed up to 4 years

  4. Time to subsequent second treatments (TTST-2)

    Time to subsequent treatment (TTST) is the time from randomization to initiation of second subsequent treatment (including treatment change due to toxicity or investigator's decision). Deaths will be counted as events. Patients alive and not receiving a subsequent treatment will be censored at the last assessment date.

    Measured: from date to randomization to date of event, assessed up to 4 years

  5. Overall Survival (OS)

    Overall Survival (OS) is defined as time from randomization to the date of death, whatever the cause. Patients alive at the cut-of date will be censored at the last date they are known to be alive

    Measured: from date to randomization to death from any cause, assessed up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2021
  2. Study start5 Aug 2021
  3. Primary completion15 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04713514
Sponsor's protocol ID
GINECO-OV244b
Other IDs
2020-004364-25, ENGOT-ov58
Acronym
TEDOVA
Status last verified
Oct 2026
First submitted
14 Jan 2021
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kabirian R, Tredan O, Marme F, Paoletti X, Eberst L, Lebreton C, De La Motte Rouge T, Sabatier R, Angelergues A, Fabbro M, Van Gorp T, Mansi L, Gladieff L, Kaczmarek E, Alexandre J, Grellety T, Favier L, Welz J, Frenel JS, Leary A. TEDOVA: vaccine OSE2101 +/- pembrolizumab as maintenance in platinum-sensitive recurrent ovarian cancer. Future Oncol. 2024;20(35):2699-2708. doi: 10.1080/14796694.2024.2386922. Epub 2024 Aug 19.

    PubMed 39155847

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OSE2101 and Pembrolizumab 25 MG/ML [Keytruda] in people with Platinum-sensitive Ovarian Cancer and Relapsed Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 41 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in France, Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: from date to randomization to date of event, assessed up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04713514, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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