Brief Title
A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors
Official Title
A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Brief 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with dose-limiting toxicities (DLTs)
Secondary Outcome
Number of participants with treatment emergent adverse events (TEAEs)
Condition
Solid Tumors
Intervention
DF6002
Study Arms / Comparison Groups
Monotherapy Dose Escalation
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
473
Start Date
July 13, 2020
Completion Date
December 16, 2025
Primary Completion Date
July 19, 2024
Eligibility 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
- Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed
by Investigator as being at high risk for venous thromboembolism (VTE) or history of
VTE ≥ 6 months from enrollment
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
- Known diagnosis of antiphospholipid syndrome or clinically significant hereditary
thrombophilia
Other protocol-defined inclusion/exclusion criteria apply
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bristol-Myers Squibb, 855-907-3286, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT04423029
Organization ID
CA101-001
Secondary IDs
2021-000038-33
Responsible Party
Sponsor
Study Sponsor
Bristol-Myers Squibb
Study Sponsor
Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Verification Date
February 2023