Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
27

Summary

Conditions
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVES: I. To determine the clinical response rate of platinum chemotherapy and pembrolizumab (MK-3475) in platinum chemotherapy pretreated ovarian, fallopian tube, and primary peritoneal. II. To examine whether retreatment with platinum chemotherapy in platinum resistant ovarian, fallop...

PRIMARY OBJECTIVES: I. To determine the clinical response rate of platinum chemotherapy and pembrolizumab (MK-3475) in platinum chemotherapy pretreated ovarian, fallopian tube, and primary peritoneal. II. To examine whether retreatment with platinum chemotherapy in platinum resistant ovarian, fallopian tube, and primary peritoneal cancers improves progression free survival by concurrent administration of MK-3475. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of concurrent administration of MK-3475 with platinum chemotherapy in patients with platinum resistant recurrent ovarian, fallopian tube, and primary peritoneal cancers. II. To determine the relationship between PD-L1 expression and response to the combination of MK-3475 and platinum. III. To assess the overall survival of patients treated with the combination of MK-3475 and platinum. EXPLORATORY OBJECTIVE: I. To explore whether treatment with MK-3475 and platinum alters soluble factors in sera, peripheral immune responses and immune cell profile. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, every 6 months for 1 year, and then every 12 weeks thereafter.

Tracking Information

NCT #
NCT03029598
Collaborators
  • National Cancer Institute (NCI)
  • Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: John Liao Fred Hutch/University of Washington Cancer Consortium