197
Participants
Start Date
September 18, 2015
Primary Completion Date
May 31, 2023
Study Completion Date
November 30, 2024
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.
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.
Cyclophosphamide
Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off.
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 ."
RECRUITING
Institut Bergonie, Bordeaux
Lead Sponsor
Collaborators (1)
National Cancer Institute, France
OTHER_GOV
Fondation ARC
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Transgene
INDUSTRY
Institut Bergonié
OTHER