Immunotherapy drug dostarlimab takes on chemo in advanced endometrial cancer trial

NCT ID NCT05201547

Disease control Sponsor: ARCAGY/ GINECO GROUP Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares the immunotherapy drug dostarlimab with standard chemotherapy in 260 women with advanced or recurrent endometrial cancer that has a specific DNA repair defect (MMR deficient). The goal is to see if dostarlimab can better delay cancer progression and improve survival. Participants receive either chemotherapy for 6 cycles or dostarlimab infusions for up to 2 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Dostarlimab (an immunotherapy drug) and carboplatin-paclitaxel (chemotherapy)
What this could lead to: If successful, this could show that dostarlimab is better than chemotherapy at controlling advanced endometrial cancer with a specific genetic feature.
What could go wrong: This is a late-stage trial, but results are not yet known. The drug may not improve survival or could cause side effects like immune-related inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must fulfil all the following criteria: 1. Female patient is at least 18 years of age, 2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements. 3. Patient with histologically proven endometrial adenocarcinoma with recurrent or advanced disease. 4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Patient must have primary Stage IIIA to C2 or Stage IV disease or first recurrent endometrial cancer (see International Federation of Gynecology and Obstetrics staging FIGO Staging 18.1) without curative treatment by radiation therapy or surgery alone or in combination, and meet at least one of the following situations: 1. Patient has patient has primary Stage IIIA-IIIC1 with no amenable curative intent surgery or radiation. 2. Patient has first recurrent disease and is chemotherapy naïve for this 1st recurrence or metastatic setting. 3. Patient has recurrent disease and is chemotherapy naïve for recurrence or advanced /metastatic setting. 4. Patient may have received prior irradiation for advanced endometrial cancer with or without radio-sensitizing chemotherapy if \> 3 weeks before the start of the study 6. Patient with evaluable disease (measurable and not measurable disease) according to RECIST 1.1 7. Patient may have received prior neo-adjuvant/adjuvant systemic chemotherapy for the primary cancer and had a recurrence ≥ 6 months after completing treatment (first recurrence only). 8. All histologic subtypes of endometrial adenocarcinoma could be included if MMRd/MSI-H 9. MMRd/MSI-H tumor (first diagnosed by routine local IHC performed either on primitive tumour tissue or on relapse/metastatic tumour sample) is mandatory for inclusion. A central confirmation will be done before inclusion; in case of ambiguous result of central IHC (lack of positive internal control, heterogeneous loss of MMR protein expression), MSI-H status will be assessed by PCR/NGS 10. Availability of 1 block for MMR/MSI status centralized confirmation for IHC or PCR/ NGS 11. . Patient could have been previously treated with hormone therapy, for the metastatic/advanced disease 12) Patient may have received pelvic and lombo-aortic external beam +/- vaginal brachytherapy 13\. Patient has adequate organ function, defined as follows: a) Absolute neutrophil count ≥ 1,500 cells/μL b) Platelets ≥ 100,000 cells/μL c) Haemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L d) Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation for patients with creatinine levels \> 1.5× institutional ULN e) Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN g) International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN. Patients receiving anticoagulant therapy must have a PT or partial thromboplastin within the therapeutic range of intended use of anticoagulants. 14\. Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of nonchildbearing potential. Nonchildbearing potential is defined as follows: 1. Patient is ≥ 45 years of age and has not had menses for \> 1 year. 2. A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for \< 2 years without a hysterectomy and oophorectomy. 3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation: * Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan. * Tubal ligation must be confirmed with medical records of the actual procedure; otherwise, the patient must fulfil the criteria in Inclusion Criterion 14. * Information must be captured appropriately within the site's source documents. 15. Patient of childbearing potential must agree to use a highly effective method of contraception (section 18.9) with their partners starting from time of consent through 150 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents). Exclusion Criteria: * Patients are to be excluded from the study if they meet any of the following criteria: 1. Patient has received neoadjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and has had a recurrence or PD within 6 months of completing this chemotherapy treatment prior to entering the study. Note: Low-dose cisplatin given as a radiation sensitizer or hormonal therapies do not exclude patients from study participation. 2. Patient has had \> 1 recurrence of endometrial cancer, treated with chemotherapy. Surgery of the recurrence is allowed. 3. Patient previously treated with systemic chemotherapy for non-curable advanced disease or metastatic disease 4. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 5. Patient has received prior anticancer therapy for (advanced or metastatic disease (targeted therapies, hormonal therapy, radiotherapy) within 21 days or \< 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed. 6. Patient with contraindication to chemotherapy or checkpoint inhibitor treatments 7. Patient has a concomitant malignancy, or patient has a prior non-endometrial invasive malignancy who has been disease-free for \< 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed. 8. Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging \[using the identical imaging modality for each assessment, either MRI or CT scan\] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability. 9. Patient has a known history of human immunodeficiency virus (HIV; HIV 1 or 2 antibodies). 10. Patient has known active viral infection of hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid \[qualitative\] detection). 11. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (eg, thyroid hormone or insulin). 12. Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment. 13. Patient has not recovered (ie, to Grade ≤ 1 or to baseline) from cytotoxic therapy-induced adverse events (AEs). Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study. 14. Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. 15. Patient has a known hypersensitivity to carboplatin, paclitaxel, or dostarlimab components or excipients. 16. Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment. 17. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent). 18. 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 at higher dose than 10 mg/day, 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. 19. Patient is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment, or lactating woman. 20. Patients who had an allogenic tissue/solid organ transplant

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium adenocarcinoma endometrium neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer

Contacts and locations

Locations

AP-HP Hôpital Pitié-Salpêtrière

Paris, 75013, France
APHM - Hôpital de la Timone

Marseille, 13005, France
Addenbrooke's Hospital

Cambridge, CB2 0QQ GB, United Kingdom
Asan Medical Center

Seoul, 05505, South Korea
Auckland City Hospital

Auckland, 1023, New Zealand
Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy
CH Simone Veil de Beauvais

Beauvais, 60000, France
CHI de Cornouaille

Quimper, France
CHRU Jean Minjoz

Besançon, 25000, France
CHU Brest

Brest, France
CHU Bretonneau

Tours, France
CHU Saint-Etienne - Pôle de Cancérologie

Saint-Etienne, 42055, France
CHU Strasbourg - Hôpital de Hautepierre

Strasbourg, France
CHU d'Amiens - Hôpital Sud

Amiens, 80054, France
CHU d'ORLEANS

Orléans, France
CHU de Dijon

Dijon, 21079, France
CHU de Poitiers - Hôpital de la Milétrie

Poitiers, 86021, France
Calvary Mater Newcastle

Waratah, 2298, Australia
Canberra Hospital

Garran, 2605, Australia
Centre Antoine Lacassagne

Nice, 06100, France
Centre Azuréen de Cancérologie

Mougins, 06250, France
Centre CARIO - HPCA

Plérin, 22190, France
Centre Eugène Marquis

Rennes, 35042, France
Centre François Baclesse

Caen, 14000, France
Centre Georges François Leclerc

Dijon, 21000, France
Centre Henri Becquerel

Rouen, 76038, France
Centre Hospitalier Général de Pau

Pau, 64046, France
Centre Hospitalier Intercommunal de Créteil

Créteil, 21079, France
Centre Hospitalier Lyon Sud

Lyon, 69310, France
Centre Hospitalier Privé de Saint-Grégoire

Saint-Grégoire, 35760, France
Centre Hospitalier William Morey

Chalon-sur-Saône, 71100, France
Centre Hospitalier d'Auxerre

Auxerre, 89011, France
Centre Jean Perrin

Clermont-Ferrand, 63000, France
Centre Léon Bérard

Lyon, 69373, France
Centre Oscar Lambret

Lille, 59020, France
Centro di Riferimento Oncologico

Aviano, 3308, Italy
Clinique Victor Hugo

Le Mans, 72000, France
Clinique de l'Europe

Amiens, 80090, France
Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy
Fukushima Medical University Hospital

Fukushima, 960-1295, Japan
GHPSO

Creil, 60109, France
Groupe Hospitalier Diaconesses-Croix Saint-Simon

Paris, 75020, France
Hospital Clínico Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain
Hospital General Universitario de Elche

Elche, Alicante, 30203, Spain
Hospital Germans Trias i Pujol / ICO Badalona

Badalona, 08916, Spain
Hospital Son Llátzer

Palma de Mallorca, 07198, Spain
Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain
Hospital Universitario Reina Sofia

Córdoba, 14004, Spain
Hospital Universitario Son Espases

Palma, 07120, Spain
Hospital Universitario de León

León, 24008, Spain
Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain
Hôpital Cochin

Paris, 75014, France
Hôpital Européen Georges Pompidou

Paris, France
Hôpital Privé du Confluent S.A.S.

Nantes, 44000, France
Hôpital Saint-Joseph

Marseille, 13285, France
Hôpital de Mont-de-Marsan

Mont-de-Marsan, France
ICL - Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France
ICM Val d'Aurelle

Montpellier, 34298, France
ICO - Centre René Gauducheau

Saint-Herblain, 44805, France
ICO Paul Papin

Angers, 49055, France
IRCCS Istituto Oncologico Giovanni Paolo II

Bari, 70124, Italy
IRCCS Ospedale San Raffaele

Milan, 20132, Italy
Institut Bergonié

Bordeaux, 33076, France
Institut Curie

Paris, 75005, France
Institut Gustave Roussy

Villejuif, 94805, France
Institut Jean Godinot

Reims, France
Institut Mutualiste Montsouris

Paris, France
Institut Paoli Calmettes

Marseille, 13273, France
Institut Sainte Catherine

Avignon, France
Institut de Cancérologie de Strasbourg Europe - ICANS

Strasbourg, 67200, France
Institut de cancérologie du gard

Nîmes, 30029, France
Istituto Europeo di Oncologia

Milan, 20141, Italy
Korea University Guro Hospital

Seoul, 08308, South Korea
Kurume University Hospital

Fukuoka, 830-0011, Japan
Médipôle de NANCY SAS

Nancy, France
National Cancer Center

Gyeonggi-do, 10408, South Korea
National Cancer Centre Singapore (NCCS)

Singapore, 169610, Singapore
National University Hospital (NUH)

Singapore, 119074, Singapore
Northampton General Hospital NHS Trust

Northampton, NN1 5BD GB, United Kingdom
Oncopole Claudius Regaud - IUCT Oncopole

Toulouse, 31059, France
Ospedale "Santa Maria delle Croci"

Ravenna, 48121, Italy
Ospedale "Umberto I"

Lugo, 48022, Italy
Ospedale Civile degli Infermi

Faenza, 48018, Italy
Ospedale San Luca

Lucca, 55100, Italy
Ospedale degli Infermi

Biella, 13875, Italy
Policlinco Umberto I

Roma, 00161, Italy
Princess Margaret Cancer Centre

Toronto, M5G2M9, Canada
Queen Elizabeth Hospital

Birmingham, B15 2GW GB, United Kingdom
ROC 37

Chambray-lès-Tours, France
Royal Cornwall Hospital

Truro, 3LJ GB, United Kingdom
Saitama Medical University International Medical Center

Saitama, 350-1298, Japan
Samsung Medical Center

Seoul, 06351, South Korea
Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea
Seoul National University Hospital

Seoul, 03080, South Korea
Spedali Civili-Università di Brescia

Brescia, 25123, Italy
The Cancer Institute Hospital Of JFCR

Kōtoku, 135-8550, Japan
University College London Hospital

London, NW1 2PG GB, United Kingdom
Western General Hospital

Edinburgh, EH42XU, United Kingdom
Yonsei Medical Center Severance Hospital

Seoul, 03722, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.