Testing the Addition of Nivolumab to Chemotherapy for Patients With Metastatic Anal Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression free survival (PFS) versus systemic chemotherapy alone. SECONDARY OBJECTIVES: I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly ...

PRIMARY OBJECTIVE: I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression free survival (PFS) versus systemic chemotherapy alone. SECONDARY OBJECTIVES: I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved overall survival (OS) versus systemic chemotherapy alone. II. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved objective response using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 versus systemic chemotherapy alone. III. To evaluate toxicity profiles of the two regimens. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive carboplatin intravenously (IV) on day 1, and paclitaxel IV on days 1, 8 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive carboplatin on day 1, paclitaxel IV on days 1, 8 and 15, and nivolumab IV over 30 minutes on days 1 and 15 of cycle 1, and then on day 1 only of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, then every 3 months for 2 years.

Tracking Information