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

Official Title

A Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

Summary:

This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumour cells to grow and spread.

Trial Description

Primary Outcome:

• Disease free survival

Secondary Outcome:

• Objective response rate
• Severe toxicity interval
• Colostomy-free survival
• Overall survival
• Incidence of toxicities

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.

View this trial on ClinicalTrials.gov