Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorARCAGY/ GINECO GROUP
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Niraparib
DrugPARP Inhibitor
Niraparib + TSR-042 (Dostarlimab)
Combination productCombination of 2 drugs, a PARP Inhibitor and an Anti-PD-1
Chemotherapy Drugs
DrugChemotherapies given in standard of care
Treatment groups
138 Participants
are divided into 3 treatment groupsGroup A: Arm A - NiraparibExperimental treatment 1 intervention
Group B: Arm B - Niraparib + TSR-042 (Dostarlimab)Experimental treatment 1 intervention
Group C: Arm C - Chemotherapy drugsActive comparator 1 intervention
Trial outcomes
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 included2
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 includedSecondary 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 included2
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 included3
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 included4
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 includedSponsors and contacts
Click on the lead sponsor to view all of their trials.
ARCAGY/ GINECO GROUP
Lead sponsor
Tesaro, Inc.
Collaborator
Source ClinicalTrials.gov