Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

• Status: Completed
• Trial end date: 2021-05-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Dacarbazine; Nivolumab

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Men and women ≥18 years of age

• Eastern Cooperative Oncology Group Performance Status of 0 or 1

• Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer

• Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1

• Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

• Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

• Active brain metastases or leptomeningeal metastases

• Ocular melanoma

• Any active, known, or suspected autoimmune disease