Georgia's Online Cancer Information Center

Find A Clinical Trial

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

Status
Active
Cancer Type
Appendix Cancer
Bone and Soft Tissue (including Sarcoma)
Brain Cancer
Colon/Rectal Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCT ID
NCT02834013
Protocol IDs
S1609 (primary)
NCI-2016-01041
Study Sponsor
National Cancer Institute

Summary

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:

I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in each cohort.

II. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria.

III. To collect specimens for banking for use in future correlative biomarker research studies.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 10 years from registration.

Treatment Sites in Georgia

Atlanta VA Medical Center


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

Emory University Hospital - Midtown


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

Harbin Clinic Cancer Center


255 West Fifth Street
Rome, GA 30165
706-528-9110
www.harbinclinic.com

Pearlman Cancer Center at South Georgia Medical Center


2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org

Piedmont Fayette Hospital


1255 Highway 54 West
Fayetteville, GA 30214
404-851-2340
www.piedmont.org

Piedmont Hospital - Atlanta


1968 Peachtree Road, NW
Atlanta, GA 30309
www.piedmont.org

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.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.