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A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma

Melanoma Stage IV Clinical Trial

Official title:
A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma

Clinical Trial Summary

This research study is studying different immunotherapy regimens as a possible treatment for stage III or IV resectable melanoma.

Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has approved OPDIVO® (nivolumab), YERVOY® (ipilimumab), and a combination of the two as treatment options for metastatic melanoma.

The FDA (the U.S. Food and Drug Administration) has not approved the combination of nivolumab and BMS-986205 as a treatment for any disease. This research study is looking for more information on the efficacy the combination of nivolumab and BMS-986205 in the treatment of melanoma.

Nivolumab, Ipilimumab, and BMS-986205 are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab, Ipilimumab, and BMS-986205 work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer.

In this research study, the investigators are going to look at the following while the participants are receiving the study drug(s):

• The effectiveness (how well the drug works), safety, and tolerability of Nivolumab, BMS-986205 and Nivolumab, and Ipilimumab and Nivolumab in people with resectable stage III or IV melanoma ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04007588
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Withdrawn
Phase Phase 2
Start date September 6, 2019
Completion date December 19, 2019
View Details
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