Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB 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 tumor cells to grow and spread.

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

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

Sponsors & Collaborators

• Canadian Cancer Trials Group

  collaborator NETWORK

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Lakshmi Rajdev · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-05

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations