Study of OSE2101 vaccine alone or with pembrolizumab as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer after chemotherapy

2 1 1 1

What is this study about?

This study focuses on patients with platinum-sensitive recurrent ovarian cancer. The research evaluates two treatment approaches as maintenance therapy after chemotherapy. The first treatment uses a cancer vaccine called TEDOPI (also known as OSE2101) alone, while the second approach combines TEDOPI with pembrolizumab (also known as KEYTRUDA). These treatments will be compared to standard supportive care.

The main purpose is to determine how effective these maintenance treatments are in preventing cancer progression in patients who have responded to platinum-based chemotherapy. The study will last up to 24 months, during which patients may receive either TEDOPI as an injection under the skin, pembrolizumab as an infusion into a vein, a combination of both treatments, or supportive care.

TEDOPI is a type of treatment called a cancer vaccine that helps the body’s immune system fight cancer cells. Pembrolizumab is a medication that works by helping the immune system detect and attack cancer cells. Both treatments are designed to strengthen the body’s natural defenses against cancer.

1 Initial treatment preparation

Your eligibility for the trial has been confirmed through genetic testing for HLA-A2 phenotype

The treatment must begin within 8 weeks after your last chemotherapy dose

Initial health assessments include blood tests to verify adequate organ function

2 Treatment assignment

You will be randomly assigned to one of three treatment groups:

Group 1: TEDOPI vaccine alone, given by subcutaneous injection

Group 2: TEDOPI vaccine plus KEYTRUDA (pembrolizumab) given by intravenous infusion

Group 3: Best supportive care (standard medical care without the study medications)

3 Treatment period

Regular medical assessments will monitor your health status

Imaging scans will be performed to evaluate your response to treatment

Blood tests will be conducted to monitor organ function

Side effects will be tracked using a standardized rating system

4 Follow-up period

Your health status will continue to be monitored after treatment completion

Regular imaging scans will check for signs of disease progression

The study will track how long it takes before any additional cancer treatments are needed

Long-term survival monitoring will continue until the study ends in December 2025

5 Study completion

Your participation ends if the disease progresses

You may need to provide tumor tissue samples for biomarker testing

The study team will document your overall health status and survival information

Who Can Join the Study?

  • Must be 18 years or older
  • Must be diagnosed with non-mucinous epithelial ovarian cancer confirmed by tissue examination
  • Must have HLA-A2 positive genetic marker (determined by a blood test)
  • Must have good physical performance (able to carry out light daily activities)
  • Must be within 8 weeks from last chemotherapy treatment
  • Must have adequate organ function including:
    • White blood cells ≥3000/mm3
    • Neutrophils ≥1500/mm3
    • Platelets ≥100,000/mm3
    • Hemoglobin ≥9 g/dL
    • Liver and kidney function within acceptable ranges
  • Must have tumor tissue available for testing
  • For women who can become pregnant:
    • Must have a negative pregnancy test within 72 hours before starting treatment
    • Must use effective birth control during treatment and for 180 days after the last dose
  • Must be willing and able to follow all study procedures
  • Must have previously received platinum-based chemotherapy with a positive response
  • Must have either previously received PARP inhibitor treatment or be ineligible for it
  • Must have either previously received bevacizumab treatment or have a medical reason preventing its use

Who Cannot Join the Study?

  • Previous allergic reactions to any cancer treatments or medications
  • Active autoimmune diseases (conditions where the body’s immune system attacks its own tissues) requiring systemic treatment
  • Participation in another clinical trial within the last 30 days
  • Male patients (study is designed for female participants only)
  • Patients under 18 years of age
  • Presence of active infections requiring treatment
  • Significant heart problems or uncontrolled high blood pressure
  • History of other cancers within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Serious medical conditions that could interfere with study participation
  • Pregnancy or breastfeeding
  • Unable to understand or sign informed consent
  • Known brain metastases (cancer spread to the brain)
  • Active hepatitis B or C infection
  • Current treatment with other experimental drugs
  • History of organ transplantation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
CHU de Liege Liege Belgium
Centre Jean Perrin Clermont Ferrand France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital De Libramont Libramont-Chevigny Belgium
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hopital Prive Jean Mermoz Lyon France
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier De Cholet Cholet France
Hopital Prive Des Cotes D’armor Plerin France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Institut Sainte Catherine Avignon France
Societe De Recherche Oncologique Clinique 37 Chambray Les Tours France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Centre Hospitalier De Pau Pau France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Groupe Hospitalier Rance Emeraude Saint-Malo France
Universitaetsklinikum Leipzig AöR Leipzig Germany
Ifratoth Rdjsczwj Dm Cwoqgs Df Melvzygmkrx Montpellier France
Cpjaaj Lgnm Btakzf Lyon France
Ctxxmr Huoshspbase Ey Ubambgvmwdmuz Dw Lbygcws Limoges France
Arjkvcdeiy Pzdkklvq Hlqlkhzv Dx Pnyqg Paris France
Bsmelnmj Ufisjfyakp Hjzxlbfl Cvlird Besançon France
Kheuyyge Efokvjqsohnqjglzhgqlchms Hnkkryhujpfsbjucs Essen Germany
Ixejivgl dc Cztvhprszwva Handvginnkw Ubjksikpissap dn Sofug Egnzbkg (ifzppnr Saint Priest En Jarez France
Itnujrfy Pgbfcstuqfvnyti Cqddeb Coevie Marseille France
Cnharx Ozedv Lklrmwd Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
05.08.2021
France France
Not recruiting
05.08.2021
Germany Germany
Not recruiting
05.08.2021

Trial locations

OSE2101 (TEDOPI) is a neo-epitope based vaccine designed to stimulate the immune system to fight against ovarian cancer cells. It works by teaching the body’s immune system to recognize and attack specific markers found on cancer cells.

Pembrolizumab is an immunotherapy medication that belongs to a group called PD-1 inhibitors. It works by helping the immune system fight cancer cells. This medication blocks certain proteins that can prevent the immune system from attacking cancer cells effectively.

Best supportive care is not a medication but rather a combination of treatments and care measures aimed at improving the quality of life of cancer patients. It includes managing symptoms, providing pain relief, and addressing other health concerns that may arise during cancer treatment.

Platinum-sensitive recurrent ovarian cancer – A form of ovarian cancer that returns after a period of remission following initial platinum-based chemotherapy treatment. The cancer is considered platinum-sensitive when it recurs more than six months after completing the initial platinum-based therapy. This condition develops when cancer cells begin to grow again in or around the ovaries, fallopian tubes, or nearby areas in the abdomen. The disease typically follows a pattern of remission and recurrence, where periods of cancer growth alternate with periods of response to treatment. It affects the female reproductive system and can spread to other parts of the body over time.

Trial ID:
2024-516096-32-00
Protocol code:
GINECO-OV244b
NCT ID:
NCT04713514
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Phase 3 Study of LY4170156 (Sofetabart Mipitecan) with drug combination in platinum‑resistant and platinum‑sensitive ovarian cancer patients

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark France Germany +9
  • A study of sacituzumab tirumotecan and bevacizumab in patients with newly diagnosed advanced ovarian cancer following first-line platinum-based chemotherapy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Austria Belgium Czechia Denmark Finland France +9