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RecruitingNCT03651206ROCSANUpdated Sep 9, 2026

Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

A Phase 2/3 interventional study of Niraparib and Niraparib + TSR-042 (Dostarlimab) in Ovarian Carcinosarcoma and Endometrial Carcinosarcoma, sponsored by ARCAGY/ GINECO GROUP. Recruiting at 36 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by ARCAGY/ GINECO GROUP · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 3 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) \< 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is \<20%, progression-free survival (PFS) \<4 months, and OS \<1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

02

Conditions studied

  • Ovarian Carcinosarcoma
  • Endometrial Carcinosarcoma

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Keywords

  • Malignant mixed Mullerian tumors
  • Metastatic ovarian carcinosarcoma
  • Recurrent ovarian carcinosarcoma
  • Metastatic endometrial carcinosarcoma
  • Recurrent endometrial carcinosarcoma
  • Niraparib
  • TSR-042 (Dostarlimab)
03

In context

Carcinosarcoma

60 studies on the registry are indexed under Carcinosarcoma; 12 are open to participants now.

This study's planned enrollment of 138 is above the median of 48 across 52 interventional studies indexed under Carcinosarcoma.

Browse Carcinosarcoma studies →

Lead sponsor

ARCAGY/ GINECO GROUP is the lead sponsor of 51 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Progressive or recurrent uterine carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT).
  2. The primary diagnosis must be confirmed by pathological expert review of the initial tumor or at relapse.
  3. Mandatory tumor samples: Availability of an archival FFPE tumor sample(s) from diagnosis, or if not available from relapse setting.
  4. Progressive disease as defined by 1.1.
  5. Failure after ≥1 prior platinum containing regimen, which may have been given in the setting.
  6. Patient must have had 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have included chemotherapy, chemotherapy and radio-chemotherapy, and/or consolidation/maintenance therapy.
  7. Patient must be free of active infection requiring antibiotics.
  8. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to beginning protocol treatment; continuation of hormone replacement therapy is permitted.
  9. Patient must have Performance Status ≤1.
  10. of > 2 months.

  11. Adequate bone marrow function:

    • count greater than or equal to 100,000/mm3
    • (ANC) greater than or equal to 1,500/mm3
    • > 9g/dL

  12. Adequate hepatic and renal function:

    • Total ≤1.5x (ULN) unless liver are present, in which case they must be ≤3x ULN (≤2.0 in patients with known Gilberts syndrome OR direct bilirubin ≤ 1 x ULN)
    • Serum creatinine ≤1.5x upper limit of normal (ULN) or calculated ≥ 60 mL/min using Cockcroft-Gault equation
    • (AST) and alanine aminotransferase (ALT) ≤2.5x ULN unless liver metastases are present, in which case they must be ≤5x ULN
    • Alkaline phosphatase \< 2.5 times ULN
    • Serum albumin > 3 g/dL
  13. (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  14. Patient must have normal BP or adequately treated and controlled hypertension (systolic BP≤140 mmHg and/or diastolic BP ≤90 mmHg)
  15. Patient receiving may continue as long as their dose is stable and ≤10mg/day (prednisone equivalent) for at least 4 weeks prior to initiating protocol therapy.
  16. Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment.

  17. Patient has a negative urine or serum pregnancy test within 72 hours prior to taking study treatment if of and agrees to abstain from activities that could result in pregnancy from screening through 4 monhs after the last dose of study treatment, or is of nonchildbearing potential.

    • Non-childbearing potential is defined as follows:

      • ≥45 years of age and has not had menses for >1 year
      • Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the range upon screening evaluation
      • 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. Tubal ligation must be confirmed with medical records of the actual procedure.
    • For women of childbearing potential: the patient must be willing to use a highly effective measure throughout the study, starting with the screening visit through 4 months after the last dose of study treatment. See Section 4.3. for a list of highly effective contraception methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
  18. Patient must agree to not breastfeed during the study and for 4 months after the last dose of study treatment.
  19. Patient able to take oral medications.
  20. Female aged ≥18 years at time of signing ICF.
  21. Patient must have signed an approved .
  22. For France only: patient affiliated to, or a beneficiary of, a social security category.

Exclusion criteria

Exclusion Criteria:

  1. Not enrolled in any interventional clinical trial (except to biological trials that must be validated by the sponsor)
  2. Prior treatment with niraparib or other PARPi therapy or PD1/PDL-1 inhibitors.
  3. Patient has had therapy, immunotherapy, chemotherapy or biological therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to treatment initiation. Patient has had radiotherapy within 4 weeks prior to treatment initiation.
  4. Patients must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
  5. Patient who has received more than 3 prior cytotoxic chemotherapies for management of uterine carcinosarcoma.
  6. Patient with persistent, > Grade 1 toxicity.
  7. Patient has clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina \< 6 months to enrollment, grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months)
  8. Patient with any other severe concurrent disease, which may increase the risk associated with study participation or study drug administration and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, including significant neurologic, psychiatric, infectious, hepatic, renal, or gastrointestinal diseases or laboratory abnormalities. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining .
  9. Symptoms or signs of gastrointestinal obstruction requiring parenteral nutrition or hydration or any other gastro-intestinal disorders or abnormalities, including difficulty swallowing, that would interfere with drug absorption.
  10. Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities
  11. Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks prior to Day 1 of protocol therapy or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  12. Patient has a diagnosis of immunodeficiency or has received systemic therapy >10mg/day (prednisone equivalent) or any other form of therapy within 7 days prior to initiating protocol therapy

  13. Participants with known infection are allowed with the following requirements:

    Documented evidence of plasma HIV-1 RNA persistently \<50 copies/mL ≤3 months prior to AND at Screening. In the >3 to 12 months prior to Screening, plasma HIV-1 RNA consistently \<50 c/mL required; if single increases ≥50 c/mL occurred, they cannot have been persistent nor associated with antiretroviral resistance per investigator assessment AND >350 cells/mm3 over past 12 months and at Screening (and no measurement ≤350 cells/mm3 during that time period) AND Must be on an uninterrupted combination antiretroviral therapy regimen for at least 3 months prior to Screening, with combination antiretroviral therapy regimen consistent with locally recommended guidelines Participants with history of CDC Stage 3 AIDS-defining disease (CDC, 2014; also known as acquired immunodeficiency syndrome - defining disease) are allowed if AIDS-defining disease has been treated and cured or is stable for ≥3 months prior to study entry. Cutaneous Kaposi's sarcoma not requiring systemic therapy is allowed.

    No history of HIV-associated non-Hodgkin lymphoma ≤5 years prior to study entry.

    No treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening

  14. Patient has known active (e. g., hepatitis B surface antigen [HBsAg] reactive and HBcAb reactive) or (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
  15. Patient has an active disease that has required systemic treatment in the past 2 years (ie, 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.
  16. Patient must not have a history of interstitial lung disease.
  17. Patient has received a within 30 days of initiating protocol therapy.
  18. Patient must not have received a transfusion ( or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
  19. Patient must not have received colony-stimulating factors (e.g, granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  20. Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  21. Symptomatic or .
  22. Patients with a history of other invasive (any evidence of other malignancy being present within the last 3 years) or with a concomitant invasive malignancy, with the exception of non-melanoma skin cancer; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy.
  23. Known reactions or allergy to investigational drugs or their that contraindicates the subject's participation.
  24. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; those considerations should be discussed with the patient before registration in the trial.
  25. Patients under psychiatric care and patients admitted to a health or social institution.
  26. Patients deprived of their liberty by judicial or administrative decision.
  27. Patients under a legal protection measure or unable to express their consent.
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    Arm A - Niraparib

    Niraparib, 200 mg or 300 mg, daily dose

    Drug: Niraparib

  • Experimental
    Arm B - Niraparib + TSR-042 (Dostarlimab)

    Niraparib, 200 mg or 300 mg, daily dose TSR042, intravenous infusion on Day 1 of every 21-day cycle at 500 mg for the 4 first cycles, followed by 1,000 mg on Day 1 of every 42-day cycle thereafter

    Combination Product: Niraparib + TSR-042 (Dostarlimab)

  • Active comparator
    Arm C - Chemotherapy drugs

    Chemotherapies (Standard of care) For Ovarian Cancer Patients Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Pegylated Liposomal Doxorubicin, 40 mg/m², Intravenous, every 28 days Topotecan, 4mg/m², Intravenous, Day 1, 8, 15 every 28 days For Endometrial Cancer Patients Doxorubicin, 60 mg/m², Intravenous, every 21 days Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Gemcitabine, 800 mg/m², Intravenous, Day 1, 8 every 21 days

    Drug: Chemotherapy Drugs

Interventions

  • DrugNiraparib

    PARP Inhibitor

  • Combination productNiraparib + TSR-042 (Dostarlimab)

    Drug page: Dostarlimab

    Combination of 2 drugs, a PARP Inhibitor and an Anti-PD-1

  • DrugChemotherapy Drugs

    Chemotherapies given in standard of care

06

What researchers measure

Primary outcomes

  1. Response Rate (RR) at 4 months

    RR is defined as the proportion of patients with a partial response or complete response 4 months after randomization

    Time frame: 4 months after the last patient included

  2. Overall survival (OS)

    OS is the time from the date of the randomization until death due to any cause

    Time frame: 1 year after the last patient included

Secondary outcomes

  1. Progression Free Survival (PFS)

    PFS is the time from randomization to the date of event defined as the first documented progression (RECIST 1.1) or death due to any cause.

    Time frame: 1 year after the last patient included

  2. Time To Subsequent Treatment (TTST)

    TTST is the time from the date of randomization to the earliest date of anti-cancer therapy start following study treatment discontinuation, or death by any cause in the absence of start of new anti-cancer therapy

    Time frame: 1 year after the last patient included

  3. Progression-Free Survival 2 (PFS2)

    PFS2 is the time from the date of randomization to the second objective disease progression, or death from any cause, whichever occurs first.

    Time frame: 1 year after the last patient included

  4. Objective Response Rate (ORR)

    ORR is the proportion of patients with a best response of Complete Response or Partial Response.

    Time frame: 1 year after the last patient included

  5. Adverse events

    Assessed by CTCAE 5.0

    Time frame: 1 year after the last patient included

  6. Patient-reported outcomes (PROs)

    Assessed with questionnaires to be completed by patient and collected frequently during the study

    Time frame: 1 year after the last patient included

07

Study locations

16 of 36 sites recruiting
  • ICO Paul Papin
    Angers, 49055, France
    Recruiting
    • Paule AUGEREAU, MD · Principal investigator
  • CHRU Jean Minjoz
    Besançon, 25000, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Centre Régional de Lutte contre le cancer - Institut Bergonié
    Bordeaux, 33000, France
    Recruiting
    • Coriolan LEBRETON, MD · Principal investigator
  • CHU de BREST - Hôpital Cavale Blanche
    Brest, 29200, France
    Not yet recruiting
    • Laura DEIANA, MD · Contact
  • Centre François Baclesse
    Caen, 14000, France
    Recruiting
    • Florence Joly, MD · Principal investigator
  • Centre Jean Perrin
    Clermont-Ferrand, 63000, France
    Recruiting
    • Elsa KALBACHER, MD · Principal investigator
  • Centre Georges François Leclerc
    Dijon, 21079, France
    Not yet recruiting
    • Jean-David FUMET, MD · Principal investigator
  • Centre Oscar Lambret
    Lille, 59000, France
    Recruiting
    • Mathilde SAINT-GHISLAIN, MD · Principal investigator
  • CHU de Limoges - Hôpital Dupuytren
    Limoges, 87042, France
    Not yet recruiting
    • Laurence VENAT, MD · Principal investigator
  • Centre Léon Bérard
    Lyon, 69001, France
    Recruiting
    • Isabelle Ray Coquard, MD · Principal investigator
  • Institut Paoli Calmettes
    Marseille, 13000, France
    Recruiting
    • Magali Provansal, MD · Principal investigator
  • Hôpital Privé du Confluent S.A.S.
    Nantes, 44000, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Centre Hospitalier Universitaire de Nîmes, Institut de Cancérologie du GARD
    Nîmes, 30900, France
    Not yet recruiting
    • Delphine DULIEGE, MD · Principal investigator
  • Groupe Hospitalier des Diaconesses Croix Saint-Simon
    Paris, 75020, France
    Recruiting
    • Antoine ANGELERGUES, MD · Principal investigator
  • Institut Curie
    Paris, 76016, France
    Recruiting
    • Audrey Bellesoeur, MD · Principal investigator
  • Hopital Milétrie - Centre Hospitalier Universitaire Poitiers
    Poitiers, 86000, France
    Recruiting
    • Sheik EMAMBUX · Contact
    • Sheik EMAMBUX, MD · Principal investigator
  • Centre Eugène Marquis
    Rennes, 35000, France
    Recruiting
    • Claudia LEFEUVRE-PLESSE, MD · Principal investigator
  • ICO - Centre René Gauducheau
    Saint-Herblain, 44800, France
    Recruiting
    • Dominique Berton, MD · Principal investigator
  • CHU Saint-Etienne - Pôle de Cancérologie
    Saint-Priest-en-Jarez, 42271, France
    Not yet recruiting
    • Pauline CORBAUX, MD · Principal investigator
  • ICANS
    Strasbourg, 67200, France
    Completed

    Not enrolling at this site — choose another above.

  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, France
    Recruiting
    • Lauriane EBERST · Contact
  • IUCT Oncopole - Institut Claudius Régaud
    Toulouse, 31000, France
    Recruiting
    • Laurence Gladieff, MD · Principal investigator
  • ICL - Centre Alexis Vautrin
    Vandœuvre-lès-Nancy, 54519, France
    Not yet recruiting
    • Yolanda FERNANDEZ, MD · Contact
  • Institut Gustave Roussy
    Villejuif, 94800, France
    Recruiting
    • Alexandra Leary, MD · Principal investigator
  • Azienda Ospedaliero-Universitaria di Bologna IRCCS Istituto di Ricerca e di Cura a Carattere Scientifico
    Bologna, 40138, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliera Per L'Emergenza Cannizzaro
    Catania, 95126, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
    Meldola, 47014, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Ospedale San Raffaele S.r.l.
    Milan, 20132, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Humanitas Mirasole S.p.A.
    Milan, 20159, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale
    Naples, 80131, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, 00168, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliera Ordine Mauriziano Di Torino
    Torino, 10128, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Universitario Ramon Y Cajal
    Madrid, 28034, Spain
    Recruiting
    • Eva Maria GUERRA, Dr · Contact
  • Hospital Universitario 12 De Octubre
    Madrid, 28041, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Virgen de la Arrixaca
    Murcia, 30120, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Clinico Universitario De Valencia
    Valencia, 46010, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

08

References and documents

Individual participant data

Plan to share: No — No sharing plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03651206
Lead sponsor
ARCAGY/ GINECO GROUP
Collaborators
Tesaro, Inc.
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Jul 15, 2020
Primary completion
Jun 2027 (estimated)
Completion
Mar 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Isabelle RAY-COQUARD, Professor
Contact
balauze@arcagy.org
+33184852020
Sébastien ARMANET
Contact
balauze@arcagy.org
+33184852020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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