Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial

PHASE2UnknownINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

November 24, 2020

Study Completion Date

August 31, 2021

Conditions
Sarcoma
Interventions
DRUG

Combination of MK3475 with Metronomic CP

"Combination of MK3475 with Metronomic CP. Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule.~MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation."

DRUG

Combination of MK3475 with Metronomic CP and G100

"Combination of MK3475 with Metronomic CP and G100. Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule.~MK3475 will be administered intravenously (200 mg), and given every 3 weeks on day 8.~G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase).~A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation."

Trial Locations (8)

13273

Institut Paoli Calmettes, Marseille

31052

Institut Claudius Regaud, Toulouse

33076

Institut Bergonié, Bordeaux

44805

Institut de Cancérologie de l'Ouest, Saint-Herblain

59020

Centre Oscar Lambret, Lille

69373

Centre Léon Bérard, Lyon

75005

Institut Curie, Paris

94800

Institut Gustave Roussy, Villejuif

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Ministry of Health, France

OTHER_GOV

collaborator

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

lead

Institut Bergonié

OTHER