NCT03233711

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 tumor cells to grow and spread.

Detailed 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) 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) while on study. ARM B: Patients undergo observation while on study Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), biopsy and blood sample collection throughout the study.

Conditions

• Anal Basaloid Carcinoma
• Anal Canal Cloacogenic Carcinoma
• Anal Margin Squamous Cell Carcinoma
• Stage IIB Anal Cancer AJCC v8
• Stage III Anal Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Colonoscopy	Undergo colonoscopy
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Digital Rectal Examination	Undergo digital rectal examination
PROCEDURE	High Resolution Anoscopy	Undergo anoscopy
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
BIOLOGICAL	Nivolumab	Given IV
OTHER	Patient Observation	Undergo observation
PROCEDURE	Proctoscopy	Undergo proctoscopy
PROCEDURE	Sigmoidoscopy	Undergo sigmoidoscopy
PROCEDURE	X-Ray Imaging	Undergo chest x-ray

Timeline

• Start date: 2018-07-05
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2017-07-31
• Last updated: 2026-04-13

Locations

899 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study