Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
ConditionSmall Cell Ovarian Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age12+
SponsorARCAGY/ GINECO GROUP
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient who are at least 12 years of age on the day of signing informed consent with previously untreated, pathologically confirmed Small cell carcinoma of the ovary.Patients could be included after one cycle of chemotherapy but have to start treatment within 4 weeks after the first cycle of chemotherapy. They will start the scheme at cycle 2.
Stage FIGO I to IV classification
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate marrow function
Disqualifiers
Prior therapy for the disease with chemotherapy and/or an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Patients who have received a live vaccine within 30 days prior to the first dose of study drug.
Patients who have had an allogenic tissue/solid organ transplant.
Patient who has received more than one cycle of platinum-based chemotherapy, or any prior systemic anti-cancer therapy including investigational agents for the SCCOHT. (Patients could be included after one cycle of platinum-based therapy).
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab 25 MG/ML [Keytruda]
DrugPembrolizumab (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.
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: PembrolizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete 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 includedSecondary outcomes
1
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)2
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 intake3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
ARCAGY/ GINECO GROUP
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov