A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2027-05-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 (BMS-986415) alone and in combination with Nivolumab in participants with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate

• ECOG performance status of 0 or 1

• Clinical or radiological evidence of disease

• Adequate hematological, hepatic and renal function

Exclusion Criteria:

• Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment

• Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ

• Rapidly progressive disease

• Serious cardiac illness or medical conditions

Other protocol-defined inclusion/exclusion criteria apply