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New treatment option for Ovarian Carcinosarcoma
Official title Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
ClinicalTrials.gov ID: NCT03651206
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, being studied as a potential treatment for ovarian carcinosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- Not enrolled in any treatment 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...
- 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.
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- Not enrolled in any treatment 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...
- 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.
- Patient has clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina \< 6...
- 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...
- 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...
- 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 \ 3 to 12 months prior to Screening, plasma HIV-1 RNA consistently \ 350 cells/mm3...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nantes, France
- Nîmes, France
- Paris, France
- Poitiers, France
- Rennes, France
- Saint-Herblain, France
- Saint-Priest-en-Jarez, France
- Strasbourg, France
- Toulouse, France
+ 12 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Besançon, France; Bordeaux, France; Brest, France; Caen, France; Clermont-Ferrand, France and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.