Actively Recruiting
Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
Led by ARCAGY/ GINECO GROUP · Updated on 2025-12-19
138
Participants Needed
36
Research Sites
358 weeks
Total Duration
On this page
Sponsors
A
ARCAGY/ GINECO GROUP
Lead Sponsor
T
Tesaro, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with progressive or recurrent uterine or ovarian carcinosarcoma confirmed by pathology
- Availability of recent tumor samples (within 3 months) with adequate cellularity and tumor surface
- Progressive disease within 12 months after last chemotherapy cycle as per RECIST 1.1
- Previously treated with at least one platinum-containing chemotherapy regimen
- At least one prior chemotherapy regimen for carcinosarcoma management
- No active infection requiring antibiotics
- Discontinued hormonal therapy targeting tumor at least one week before study
- ECOG performance status of 0 to 2
- Life expectancy greater than 2 months
- Adequate bone marrow, liver, and kidney function as per laboratory measures
- Controlled blood pressure or treated hypertension
- Stable corticosteroid use (≤10mg/day prednisone equivalent) allowed
- Agreement not to donate blood during study and for 90 days after last treatment
- Normal or acceptable heart function if planned for anthracycline therapy
- Negative pregnancy test if of childbearing potential and agreement to use contraception or non-childbearing status
- Agreement not to breastfeed during study and for 180 days after last treatment
- Ability to take oral medications
- Female aged 18 years or older
- Signed informed consent
- For France only: affiliated to or beneficiary of social security
You will not qualify if you...
- Participation in other interventional clinical trials except approved biological trials
- Prior treatment with niraparib, other PARP inhibitors, or PD-1/PD-L1 inhibitors
- Recent investigational therapy, immunotherapy, chemotherapy, biological therapy, or radiotherapy within specified timeframes before randomization
- Major surgery within 3 weeks before starting treatment
- Prior treatment with control arm chemotherapy regimen under specified conditions
- More than three prior cytotoxic chemotherapy treatments for carcinosarcoma
- Persistent clinically significant toxicity above Grade 1
- Clinically significant cardiovascular disease or recent serious cardiac events
- Severe concurrent diseases increasing study risks or interfering with participation
- Gastrointestinal issues affecting drug absorption
- History of severe immune-related adverse events with prior immunotherapy
- Recent radiation therapy involving bone marrow or other specified areas
- Immunodeficiency or recent immunosuppressive therapy
- Known HIV infection
- Active hepatitis B or C infection
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of interstitial lung disease
- Recent live vaccine administration
- Recent blood transfusions or colony stimulating factor use
- Severe blood cell deficiencies from prior chemotherapy lasting over 4 weeks
- History of myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic central nervous system metastases
- Other invasive malignancies within last 3 years or contraindicating previous cancer treatments
- Allergies or hypersensitivity to study drugs
- Psychological, social, or geographical factors limiting study compliance
- Under psychiatric care, institutionalized, legally protected, or unable to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
ICO Paul Papin
Angers, France, 49055
Not Yet Recruiting
2
CHRU Jean Minjoz
Besançon, France, 25000
Active, Not Recruiting
3
Centre Régional de Lutte contre le cancer - Institut Bergonié
Bordeaux, France, 33000
Active, Not Recruiting
4
CHU de BREST - Hôpital Cavale Blanche
Brest, France, 29200
Not Yet Recruiting
5
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
6
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Actively Recruiting
7
Centre Georges François Leclerc
Dijon, France, 21079
Not Yet Recruiting
8
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
9
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Not Yet Recruiting
10
Centre Léon Bérard
Lyon, France, 69001
Actively Recruiting
11
Institut Paoli Calmettes
Marseille, France, 13000
Actively Recruiting
12
Hôpital Privé du Confluent S.A.S.
Nantes, France, 44000
Active, Not Recruiting
13
Centre Hospitalier Universitaire de Nîmes, Institut de Cancérologie du GARD
Nîmes, France, 30900
Not Yet Recruiting
14
Groupe Hospitalier des Diaconesses Croix Saint-Simon
Paris, France, 75020
Actively Recruiting
15
Institut Curie
Paris, France, 76016
Actively Recruiting
16
Hopital Milétrie - Centre Hospitalier Universitaire Poitiers
Poitiers, France, 86000
Actively Recruiting
17
Centre Eugène Marquis
Rennes, France, 35000
Actively Recruiting
18
ICO - Centre René Gauducheau
Saint-Herblain, France, 44800
Actively Recruiting
19
CHU Saint-Etienne - Pôle de Cancérologie
Saint-Priest-en-Jarez, France, 42271
Not Yet Recruiting
20
ICANS
Strasbourg, France, 67200
Actively Recruiting
21
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Active, Not Recruiting
22
IUCT Oncopole - Institut Claudius Régaud
Toulouse, France, 31000
Actively Recruiting
23
ICL - Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54519
Not Yet Recruiting
24
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
25
Azienda Ospedaliero-Universitaria di Bologna IRCCS Istituto di Ricerca e di Cura a Carattere Scientifico
Bologna, Italy, 40138
Active, Not Recruiting
26
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Catania, Italy, 95126
Active, Not Recruiting
27
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Meldola, Italy, 47014
Active, Not Recruiting
28
Ospedale San Raffaele S.r.l.
Milan, Italy, 20132
Active, Not Recruiting
29
Humanitas Mirasole S.p.A.
Milan, Italy, 20159
Active, Not Recruiting
30
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, Italy, 80131
Active, Not Recruiting
31
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Active, Not Recruiting
32
Azienda Ospedaliera Ordine Mauriziano Di Torino
Torino, Italy, 10128
Active, Not Recruiting
33
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Active, Not Recruiting
34
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Active, Not Recruiting
35
Hospital Virgen de la Arrixaca
Murcia, Spain, 30120
Active, Not Recruiting
36
Hospital Clinico Universitario De Valencia
Valencia, Spain, 46010
Active, Not Recruiting
Research Team
I
Isabelle RAY-COQUARD, Professor
CONTACT
B
Bénédicte VOTAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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