Small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Pembrolizumab (200mg flat dose) will be administred in combinaison with PAVEP chemotherapy for the first 6 cycles (21-day cycle) Then, Pembrolizumab (200mg flat dose) will be administred in monotherapy until one year for patients with complete response and up to two years for patients with Stable disease or Progression response after the end of first-sequence therapy (PAVEP chemotherapy +/- High dose chemotherapy) or until disease progression.
ICO - Paul Papin
Angers, France
RECRUITINGCentre Hospitalier Universitaire d'Angers
Angers, France
ACTIVE_NOT_RECRUITINGComplete response rate
CRR is defined as the proportion of patients who reached complete response (CR), according to RECIST v1.1 after the first sequence therapy including chemotherapy associated with immunotherapy and surgery.
Time frame: Around 4 to 6 months of the last patient included
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in combinaison with chemotherapy]
Adverse Events will be described in terms of frequency according to CTCAE v5 grade
Time frame: 30 days after the end of Cycle 6 (each cycle is 21 days)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in monotherapy]
Adverse Events will be described in terms of frequency according to CTCAE v5 grade
Time frame: 30 days after last treatment intake
Progression Free Survival (PFS)
PFS is defined as the time from inclusion until the date of event defined as the first objective documented progression, according to investigator assessment of RECIST v1.1 or death (by any cause in the absence of progression).
Time frame: from date of inclusion to date of event, assessed up to 5 years
Overall Survival (OS)
OS is defined as the time from the date of inclusion until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Time frame: from date of inclusion to death, assessed up to 5 years
Partial Response Rate (PRR)
PRR is defined as the proportion of patients who reached partial response (PR), at the end of first-sequence therapy, according to RECIST v1.1.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Hospitalier Régional Universitaire de Besançon
Besançon, France
ACTIVE_NOT_RECRUITINGInstitut Bergonié
Bordeaux, France
ACTIVE_NOT_RECRUITINGCentre Georges François Leclerc
Dijon, France
ACTIVE_NOT_RECRUITINGCentre Oscar Lambret
Lille, France
ACTIVE_NOT_RECRUITINGCHU de Limoges - Hôpital Dupuytren
Limoges, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGICM Val d'Aurelle
Montpellier, France
WITHDRAWNICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, France
RECRUITING...and 3 more locations
Time frame: Around 4 to 6 months of the last patient included
Duration of Response (DoR)
DOR is defined as the duration from complete response is first met until the first objective documented progression, according to RECIST v1.1.
Time frame: assessed up to 42 months