Nivolumab after Combined Modality Therapy in Treating Patients with High Risk Stage II-IIIB Anal Cancer

Active:	No
Cancer Type:	Anal Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT03233711
Trial Phases:	Phase III	Protocol IDs:	EA2165 (primary) EA2165 NCI-2017-01347
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT03233711

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.

Objectives

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.

Treatment Sites in Georgia

Atlanta VA Medical Center
1670 Clairmont Road
Decatur, GA 30033
404-728-7680
www.atlanta.va.gov

Emory Johns Creek Hospital
6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Grady Memorial Hospital
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
www.gradyhealth.org

Summit Cancer Care at the Nancy N. Lewis and J.C. Lewis Cancer & Research Pavilion
225 Candler Drive
Suite 300
Savannah, GA 31405
www.summitcancercare.com

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.