RecruitingPhase 2NCT04602377

Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT

Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Small Cell Ovarian Carcinoma of Hypercalcemic Type


Sponsor

ARCAGY/ GINECO GROUP

Enrollment

27 participants

Start Date

Aug 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the immunotherapy drug pembrolizumab to standard chemotherapy improves outcomes for patients with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT) — an extremely rare and aggressive ovarian cancer that primarily affects young women and has very few effective treatments. **You may be eligible if...** - You are at least 12 years old - You have been recently diagnosed with SCCOHT (small cell carcinoma of the ovary) at any stage (I–IV), confirmed by pathology - You have not yet received treatment, or have received only one cycle of chemotherapy - Your overall health/functional status is good (ECOG 0 or 1) - Your blood counts, liver, and kidney function meet required levels **You may NOT be eligible if...** - You have received more than one prior cycle of chemotherapy for this cancer - Your blood counts or organ function do not meet requirements - You are pregnant or breastfeeding - You have severe immune system problems or take high-dose steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab 25 MG/ML [Keytruda]

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.


Locations(13)

ICO - Paul Papin

Angers, France

Centre Hospitalier Universitaire d'Angers

Angers, France

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Institut Bergonié

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

CHU de Limoges - Hôpital Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

ICM Val d'Aurelle

Montpellier, France

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France

Hôpital de Hautepierre

Strasbourg, France

Oncopole Claudius Regaud - IUCT Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT04602377