Clinical Trials Directory

Trials / Completed

CompletedNCT03029598

Pembrolizumab and Carboplatin in Treating Patients With Relapsed or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Anti-PD-1 Therapy in Combination With Platinum Chemotherapy for Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
29 (actual)
Sponsor
University of Washington · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies how well pembrolizumab and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and carboplatin with platinum resistant chemotherapy may work better than platinum chemotherapy alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Detailed 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, 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.

Conditions

Interventions

TypeNameDescription
DRUGCarboplatinGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
BIOLOGICALPembrolizumabGiven IV

Timeline

Start date
2017-03-14
Primary completion
2021-04-20
Completion
2021-12-31
First posted
2017-01-24
Last updated
2022-07-26
Results posted
2022-07-26

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03029598. Inclusion in this directory is not an endorsement.