NCT02406781

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study assessing the efficacy of different therapeutic strategy in patients with advanced sarcomas.

Detailed description

This is a phase 2 trial with 7 strata : * Leiomyosarcoma (strata 1) : 33 patients * Undifferentiated sarcoma (strata 2): 33 patients * Sarcomas others (strata 3) : 33 patients * Osteosarcoma (strata 4) : 33 patients * GIST (strata 5): 31 patients * Advanced soft-tissue sarcoma with immune signature (strata 6): 32 patients * Metastatic soft-tissue sarcoma (strata 7): 32 patients

Conditions

• Sarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2020-11-24
• Completion: 2023-01-15
• First posted: 2015-04-02
• Last updated: 2025-12-10
• Results posted: 2025-12-10

Locations

8 sites across 1 country: France