Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.

ABSTRACT:

Objective

To evaluate the combination of pembrolizumab, cisplatin and gemcitabine in recurrent platinum-resistant ovarian cancer.

Methods

Patients received six cycles of chemotherapy with gemcitabine and cisplatin on day 1 and day 8 of a 21-day treatment cycle. Pembrolizumab was administered on day 1 of cycles 3-6 and as maintenance monotherapy in cycles 7-34. Palliative radiation to a non-target symptomatic lesion was allowed. The primary objective was overall response rate by RECIST 1.1 criteria. Secondary objectives included safety, progression-free survival, time to progression, duration of response and overall survival.

Results

An interim analysis for futility was performed at 18 evaluable patients. Overall response rate was 60%, duration of response was 4.9 mont

SUBMITTER: Walsh CS 

PROVIDER: S-EPMC8174738 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature