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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
NCD 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.

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