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Ovarian CarcinosarcomaPhase 2/3ROCSANNCT03651206

Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

A Phase 2/3 study testing Niraparib, Niraparib + TSR-042 (Dostarlimab) and Chemotherapy Drugs in people with Ovarian Carcinosarcoma and Endometrial Carcinosarcoma, run by ARCAGY/ GINECO GROUP at 36 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Niraparib, Niraparib + TSR-042 (Dostarlimab) and Chemotherapy Drugs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
36 sitesin 3 countries
Study dates
15 Jul 2020to Mar 2029
Phase
Phase 2/3
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

  • Progressive or recurrent uterine carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT).
  • The primary diagnosis must be histologically confirmed by pathological expert review of the initial tumor or biopsy at relapse.
  • Mandatory tumor samples: Availability of an archival FFPE tumor sample(s) from diagnosis, or if not available from relapse setting.
  • Progressive disease as defined by RECIST 1.1.
  • Failure after ≥1 prior platinum containing regimen, which may have been given in the adjuvant setting.
  • 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.
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  • Patient must be free of active infection requiring antibiotics.
  • 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.
  • Patient must have ECOG Performance Status ≤1.
  • Life expectancy of > 2 months.
  • Adequate bone marrow function:
  • Platelet count greater than or equal to 100,000/mm3
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3
  • Hemoglobin > 9g/dL
  • Adequate hepatic and renal function:
  • Total bilirubin ≤1.5x Upper Limit of Normal (ULN) unless liver metastases 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 creatinine clearance ≥ 60 mL/min using Cockcroft-Gault equation
  • Aspartate aminotransferase (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
  • International normalized ratio (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.
  • Patient must have normal BP or adequately treated and controlled hypertension (systolic BP≤140 mmHg and/or diastolic BP ≤90 mmHg)
  • Patient receiving corticosteroids may continue as long as their dose is stable and ≤10mg/day (prednisone equivalent) for at least 4 weeks prior to initiating protocol therapy.
  • Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Patient has a negative urine or serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential 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 postmenopausal 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 contraception 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.
  • Patient must agree to not breastfeed during the study and for 4 months after the last dose of study treatment.
  • Patient able to take oral medications.
  • Female aged ≥18 years at time of signing ICF.
  • Patient must have signed an approved informed consent.
  • For France only: patient affiliated to, or a beneficiary of, a social security category.

Who cannot join

  • Not enrolled in any interventional clinical trial (except to biological trials that must be validated by the sponsor)
  • Prior treatment with niraparib or other PARPi therapy or PD1/PDL-1 inhibitors.
  • Patient has had investigational 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.
  • Patients must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
  • Patient who has received more than 3 prior cytotoxic chemotherapies for management of uterine carcinosarcoma.
  • Patient with persistent, clinically significant > Grade 1 toxicity.
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  • 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, NYHA 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)
  • 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 informed consent.
  • 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.
  • Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities
  • 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.
  • Patient has a diagnosis of immunodeficiency or has received systemic steroid therapy >10mg/day (prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy
  • Participants with known HIV 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 CD4 cell count >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
  • Patient has known active hepatitis B (e. g., hepatitis B surface antigen [HBsAg] reactive and HBcAb reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
  • Patient has an active autoimmune 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.
  • Patient must not have a history of interstitial lung disease.
  • Patient has received a live vaccine within 30 days of initiating protocol therapy.
  • Patient must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
  • 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.
  • Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Symptomatic CNS metastasis or leptomeningeal carcinomatosis.
  • Patients with a history of other invasive malignancies (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.
  • Known hypersensitivity reactions or allergy to investigational drugs or their excipients that contraindicates the subject's participation.
  • 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.
  • Patients under psychiatric care and patients admitted to a health or social institution.
  • Patients deprived of their liberty by judicial or administrative decision.
  • Patients under a legal protection measure or unable to express their consent.

Trial locations and contacts

36 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Isabelle RAY-COQUARD, Professor contact

+33184852020

balauze@arcagy.org

Sébastien ARMANET contact

+33184852020

balauze@arcagy.org

36 sites in 3 countries

France24 sites, 21 recruiting

  • ICO Paul Papin

    Angers, 49055

    Paule AUGEREAU, MD

    Recruiting

  • CHRU Jean Minjoz

    Besançon, 25000

    Active, not recruiting

  • Centre Régional de Lutte contre le cancer - Institut Bergonié

    Bordeaux, 33000

    Coriolan LEBRETON, MD

    Recruiting

  • CHU de BREST - Hôpital Cavale Blanche

    Brest, 29200

    Laura DEIANA, MD

    Not yet recruiting

  • Centre François Baclesse

    Caen, 14000

    Florence Joly, MD

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

    Elsa KALBACHER, MD

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Jean-David FUMET, MD

    Not yet recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Mathilde SAINT-GHISLAIN, MD

    Recruiting

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

    Laurence VENAT, MD

    Not yet recruiting

  • Centre Léon Bérard

    Lyon, 69001

    Isabelle Ray Coquard, MD

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13000

    Magali Provansal, MD

    Recruiting

  • Hôpital Privé du Confluent S.A.S.

    Nantes, 44000

    Active, not recruiting

  • Centre Hospitalier Universitaire de Nîmes, Institut de Cancérologie du GARD

    Nîmes, 30900

    Delphine DULIEGE, MD

    Not yet recruiting

  • Groupe Hospitalier des Diaconesses Croix Saint-Simon

    Paris, 75020

    Antoine ANGELERGUES, MD

    Recruiting

  • Institut Curie

    Paris, 76016

    Audrey Bellesoeur, MD

    Recruiting

  • Hopital Milétrie - Centre Hospitalier Universitaire Poitiers

    Poitiers, 86000

    Sheik EMAMBUX

    Sheik EMAMBUX, MD

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35000

    Claudia LEFEUVRE-PLESSE, MD

    Recruiting

  • ICO - Centre René Gauducheau

    Saint-Herblain, 44800

    Dominique Berton, MD

    Recruiting

  • CHU Saint-Etienne - Pôle de Cancérologie

    Saint-Priest-en-Jarez, 42271

    Pauline CORBAUX, MD

    Not yet recruiting

  • ICANS

    Strasbourg, 67200

    Completed

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

    Lauriane EBERST

    Recruiting

  • IUCT Oncopole - Institut Claudius Régaud

    Toulouse, 31000

    Laurence Gladieff, MD

    Recruiting

  • ICL - Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54519

    Yolanda FERNANDEZ, MD

    Not yet recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Alexandra Leary, MD

    Recruiting

Other trials in France

Italy8 sites

  • Azienda Ospedaliero-Universitaria di Bologna IRCCS Istituto di Ricerca e di Cura a Carattere Scientifico

    Bologna, 40138

    Active, not recruiting

  • Azienda Ospedaliera Per L'Emergenza Cannizzaro

    Catania, 95126

    Active, not recruiting

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

    Meldola, 47014

    Active, not recruiting

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

    Active, not recruiting

  • Humanitas Mirasole S.p.A.

    Milan, 20159

    Active, not recruiting

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale

    Naples, 80131

    Active, not recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

    Active, not recruiting

  • Azienda Ospedaliera Ordine Mauriziano Di Torino

    Torino, 10128

    Active, not recruiting

Other trials in Italy

Spain4 sites, 1 recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

    Eva Maria GUERRA, Dr

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

    Active, not recruiting

  • Hospital Virgen de la Arrixaca

    Murcia, 30120

    Active, not recruiting

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010

    Active, not recruiting

Other trials in Spain

About this study

Official title: An International Multicentric Randomized Phase II Evaluating Dostarlimab in Combination With Niraparib Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

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.

Being tested
Niraparib, Niraparib + TSR-042 (Dostarlimab), Chemotherapy Drugs
Keywords
Malignant mixed Mullerian tumors, Metastatic ovarian carcinosarcoma, Recurrent ovarian carcinosarcoma, Metastatic endometrial carcinosarcoma, Recurrent endometrial carcinosarcoma, Niraparib, TSR-042 (Dostarlimab)

What participants receive

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

  • NiraparibDrug

    PARP Inhibitor

  • Niraparib + TSR-042 (Dostarlimab)Combination product

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

  • Chemotherapy DrugsDrug

    Chemotherapies given in standard of care

Study groups in NCT03651206
Study groupRoleWhat they receive
Arm A - NiraparibExperimentalNiraparib, 200 mg or 300 mg, daily dose
Receives: Drug: Niraparib
Arm B - Niraparib + TSR-042 (Dostarlimab)ExperimentalNiraparib, 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
Receives: Combination Product: Niraparib + TSR-042 (Dostarlimab)
Arm C - Chemotherapy drugsActive comparatorChemotherapies (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
Receives: Drug: Chemotherapy Drugs

What is being measured

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

  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

    Measured: 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

    Measured: 1 year after the last patient included

Secondary outcomes (6)

  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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 1 year after the last patient included

  5. Adverse events

    Assessed by CTCAE 5.0

    Measured: 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

    Measured: 1 year after the last patient included

Timeline

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

  1. First posted29 Aug 2018
  2. Study start15 Jul 2020
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2029 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Step 1 : Arm A - Niraparib Arm B - Niraparib plus TSR-042 Arm C - Chemotherapy drugs Peak the winner between the Arm A or the arm B Step 2 : Single arm - Niraparib plus TSR-042
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651206
Sponsor's protocol ID
ENGOT-en8
Acronym
ROCSAN
Status last verified
Sep 2026
First submitted
20 Aug 2018
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No sharing plan

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Niraparib, Niraparib + TSR-042 (Dostarlimab) and Chemotherapy Drugs in people with Ovarian Carcinosarcoma and Endometrial Carcinosarcoma, run by ARCAGY/ GINECO GROUP at 36 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 35 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France, Italy, Spain. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Isabelle RAY-COQUARD, Professor (+33184852020, balauze@arcagy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (RR) at 4 months (time frame: 4 months after the last patient included). The study lists 2 primary outcomes in all. 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 NCT03651206.

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 9 Sep 2026.

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