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

Status
Active
Cancer Type
Colon/Rectal Cancer
Skin Cancer (Non-Melanoma)
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03233711
Protocol IDs
EA2165 (primary)
EA2165
NCI-2017-01347
Study Sponsor
ECOG-ACRIN Cancer Research Group

Summary

This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:
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 objective response rate (complete [CR] and partial [PR]), stable disease and progression.
II. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to severe toxicity interval.
III. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to colostomy-free survival.
IV. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to overall survival.
V. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to 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 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.
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