A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

September 18, 2015

Primary Completion Date

May 31, 2023

Study Completion Date

November 30, 2024

Conditions
Solid TumorsSoft-tissue SarcomaBreast Cancer
Interventions
DRUG

Cyclophosphamide and JX-594 dose escalation

Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as designated by assigned dose-level, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.

DRUG

Cyclophosphamide and JX-594

Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.

DRUG

Cyclophosphamide

Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off.

DRUG

Avelumab and JX-594 and Cyclophosphamide

"Avelumab will be administered by intravenous infusion (10 mg/kg) every 2 weeks, starting at Day 15 of cycle 1.~Cyclophosphamide wil be administered bi-daily (50 mg x 2), starting 7 days prior to cycle 1 day 1 (impregnation phase) and given on a week on/week off schedule.~JX-594 will be administered by intratumoral injection (1 x109 p.f.u) on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections ."

Trial Locations (1)

33076

RECRUITING

Institut Bergonie, Bordeaux

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Fondation ARC

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Transgene

INDUSTRY

lead

Institut Bergonié

OTHER