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Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib (ROCSAN)

Primary Purpose

Ovarian Carcinosarcoma, Endometrial Carcinosarcoma

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Niraparib
Niraparib + TSR-042 (Dostarlimab)
Chemotherapy Drugs
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Carcinosarcoma focused on measuring Malignant mixed Mullerian tumors, Metastatic ovarian carcinosarcoma, Recurrent ovarian carcinosarcoma, Metastatic endometrial carcinosarcoma, Recurrent endometrial carcinosarcoma, Niraparib, TSR-042 (Dostarlimab)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Progressive or recurrent uterine or ovarian carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT).
  2. The primary diagnosis must be histologically confirmed and central pathological review of the initial tumor or biopsy at relapse will be done.
  3. Mandatory tumor samples: Availability of tumor sample(s) from a recently (not older than 3 months) obtained archival FFPE tumor tissue block or agreement for having a new tumor biopsy if lesion amenable, with ≥ 20% cellularity and tumoral surface ≥ 8 mm².
  4. Progressive disease as defined by RECIST 1.1., within 12 months from last chemotherapy cycle.
  5. Failure after ≥1 prior platinum containing regimen, which may have been given in the adjuvant setting.
  6. Patient must have had 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have included chemotherapy, chemotherapy and radiotherapy, 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 chemotherapy; continuation of hormone replacement therapy is permitted.
  9. Patient must have ECOG Performance Status ≤2.
  10. Life expectancy of > 2 months.
  11. 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
  12. 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
  13. 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.
  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 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.
  16. Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  17. Left ventricular ejection fraction (LVEF) > Lower Limit of Normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO), for patients planned to receive Anthracycline based therapy.
  18. 18. Patient has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days 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 180 days 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.
  19. Patient must agree to not breastfeed during the study and for 180 days after the last dose of study treatment.
  20. Patient able to take oral medications.
  21. 21. Female aged ≥18 years at time of signing ICF.
  22. Patient must have signed an approved informed consent.
  23. For France only: patient affiliated to, or a beneficiary of, a social security category.

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 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 randomization. Patient has had radiotherapy within 4 weeks prior to randomization.
  4. Patient must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effect.
  5. Previous treatment with the chemotherapy regimen selected as the control arm by the investigator.

    • Prior therapy with paclitaxel given on a three-weekly regimen is permitted for patients receiving weekly Paclitaxel.
    • Prior treatment with weekly paclitaxel is permitted where this has been used as part of first line therapy and it is greater than 6 months since the last dose of weekly paclitaxel.
    • Prior weekly paclitaxel for relapsed disease is not permitted.
  6. Patients who have received more than 3 prior cytotoxic chemotherapies for management of uterine or ovarian carcinosarcoma.
  7. Patients with persistent, clinically significant > Grade 1 toxicity.
  8. 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, NHYA 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)
  9. Patients 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 abnormality. 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.
  10. 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.
  11. Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities
  12. 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.
  13. Patient has a diagnosis of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy
  14. Patient has a known history of human immunodeficiency virus (type 1 or 2 antibodies).
  15. Patient has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
  16. 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.
  17. Patient must not have a history of interstitial lung disease.
  18. Patient has received a live vaccine within 14 days of initiating protocol therapy.
  19. Patient must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
  20. Patient must not have received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  21. Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
  22. Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  23. Symptomatic CNS metastasis or leptomeningeal carcinomatosis.
  24. 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.
  25. Known, hypersensitivity reactions or allergy to investigational drugs or their excipients that contraindicates the subject's participation.
  26. 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.
  27. Patients under psychiatric care and patients admitted to a health or social institution.
  28. Patients deprived of their liberty by judicial or administrative decision.
  29. Patients under a legal protection measure or unable to express their consent.

Sites / Locations

  • ICO Paul Papin
  • CHRU Jean Minjoz
  • Centre Régional de Lutte contre le cancer - Institut Bergonié
  • Centre François Baclesse
  • Centre Jean Perrin
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • Institut Régional du Cancer de Montpellier (ICM Val d'Aurelle)
  • Hôpital Privé du Confluent S.A.S.
  • HEGP
  • Groupe Hospitalier des Diaconesses Croix Saint-Simon
  • Institut Curie
  • Centre CARIO-HPCA
  • Hopital Milétrie - Centre Hospitalier Universitaire Poitiers
  • Centre Eugène Marquis
  • ICO - Centre René Gauducheau
  • ICANS
  • IUCT Oncopole - Institut Claudius Régaud
  • ICL - Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm A - Niraparib

Arm B - Niraparib + TSR-042 (Dostarlimab)

Arm C - Chemotherapy drugs

Arm Description

Niraparib, 200 mg or 300 mg, daily dose

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

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

Outcomes

Primary Outcome Measures

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
Overall survival (OS)
OS is the time from the date of the randomization until death due to any cause

Secondary Outcome Measures

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 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
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.
Objective Response Rate (ORR)
ORR is the proportion of patients with a best response of Complete Response or Partial Response.
Adverse events
Assessed by CTCAE 5.0
Patient-reported outcomes (PROs)
Assessed with questionnaires to be completed by patient and collected frequently during the study

Full Information

First Posted
August 20, 2018
Last Updated
July 4, 2023
Sponsor
ARCAGY/ GINECO GROUP
Collaborators
Tesaro, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03651206
Brief Title
Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
Acronym
ROCSAN
Official Title
A Multicentric Randomized Phase II/III Evaluating TSR-042 (Anti-PD-1 mAb) in Combination With Niraparib (Parpi) Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCAGY/ GINECO GROUP
Collaborators
Tesaro, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinosarcoma, Endometrial Carcinosarcoma
Keywords
Malignant mixed Mullerian tumors, Metastatic ovarian carcinosarcoma, Recurrent ovarian carcinosarcoma, Metastatic endometrial carcinosarcoma, Recurrent endometrial carcinosarcoma, Niraparib, TSR-042 (Dostarlimab)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 2 : Arm A - Niraparib Arm B - Niraparib plus TSR-042 Arm C - Chemotherapy drugs Peak the winner between the Arm A or the arm B Phase 3: Arm A: The best arm of the phase 2 Arm B: Chemotherapy drugs
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Niraparib
Arm Type
Experimental
Arm Description
Niraparib, 200 mg or 300 mg, daily dose
Arm Title
Arm B - Niraparib + TSR-042 (Dostarlimab)
Arm Type
Experimental
Arm Description
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
Arm Title
Arm C - Chemotherapy drugs
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Niraparib
Intervention Description
PARP Inhibitor
Intervention Type
Combination Product
Intervention Name(s)
Niraparib + TSR-042 (Dostarlimab)
Intervention Description
Combination of 2 drugs, a PARP Inhibitor and an Anti-PD-1
Intervention Type
Drug
Intervention Name(s)
Chemotherapy Drugs
Intervention Description
Chemotherapies given in standard of care
Primary Outcome Measure Information:
Title
Response Rate (RR) at 4 months
Description
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
Title
Overall survival (OS)
Description
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 Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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
Title
Time To Subsequent Treatment (TTST)
Description
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
Title
Progression-Free Survival 2 (PFS2)
Description
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
Title
Objective Response Rate (ORR)
Description
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
Title
Adverse events
Description
Assessed by CTCAE 5.0
Time Frame
1 year after the last patient included
Title
Patient-reported outcomes (PROs)
Description
Assessed with questionnaires to be completed by patient and collected frequently during the study
Time Frame
1 year after the last patient included

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Progressive or recurrent uterine or ovarian carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT). The primary diagnosis must be histologically confirmed and central pathological review of the initial tumor or biopsy at relapse will be done. Mandatory tumor samples: Availability of tumor sample(s) from a recently (not older than 3 months) obtained archival FFPE tumor tissue block or agreement for having a new tumor biopsy if lesion amenable, with ≥ 20% cellularity and tumoral surface ≥ 8 mm². Progressive disease as defined by RECIST 1.1., within 12 months from last chemotherapy cycle. 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 radiotherapy, and/or consolidation/maintenance therapy. 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 chemotherapy; continuation of hormone replacement therapy is permitted. Patient must have ECOG Performance Status ≤2. 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. Left ventricular ejection fraction (LVEF) > Lower Limit of Normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO), for patients planned to receive Anthracycline based therapy. 18. Patient has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days 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 180 days 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 180 days after the last dose of study treatment. Patient able to take oral medications. 21. 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. Exclusion Criteria: 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 randomization. Patient has had radiotherapy within 4 weeks prior to randomization. Patient must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effect. Previous treatment with the chemotherapy regimen selected as the control arm by the investigator. Prior therapy with paclitaxel given on a three-weekly regimen is permitted for patients receiving weekly Paclitaxel. Prior treatment with weekly paclitaxel is permitted where this has been used as part of first line therapy and it is greater than 6 months since the last dose of weekly paclitaxel. Prior weekly paclitaxel for relapsed disease is not permitted. Patients who have received more than 3 prior cytotoxic chemotherapies for management of uterine or ovarian carcinosarcoma. Patients with persistent, clinically significant > Grade 1 toxicity. 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, NHYA 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) Patients 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 abnormality. 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 or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy Patient has a known history of human immunodeficiency virus (type 1 or 2 antibodies). Patient has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] 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 14 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 (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. 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.
Facility Information:
Facility Name
ICO Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CHRU Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Centre Régional de Lutte contre le cancer - Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69001
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Institut Régional du Cancer de Montpellier (ICM Val d'Aurelle)
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hôpital Privé du Confluent S.A.S.
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
HEGP
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Groupe Hospitalier des Diaconesses Croix Saint-Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
76016
Country
France
Facility Name
Centre CARIO-HPCA
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
Hopital Milétrie - Centre Hospitalier Universitaire Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
ICO - Centre René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
ICANS
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
IUCT Oncopole - Institut Claudius Régaud
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
ICL - Centre Alexis Vautrin
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing plan

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Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

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