Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma. SECONDARY OBJECTIVES: I. To compare nivolumab following combined modality therapy (CMT)...

PRIMARY OBJECTIVE: I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma. SECONDARY OBJECTIVES: I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to: Ia. Objective response rate (complete [CR] and partial [PR]), stable disease and progression. Ib. Severe toxicity interval. Ic. Colostomy-free survival. Id. Overall survival. Ie. Toxicity. OUTLINE: Patients who received standard CMT are randomized to 1 of 2 arms. ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo observation for up to 6 months. After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

Tracking Information