Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print Created with Sketch. YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Health Study Area: Breast Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Please Log In/Join Now first, and then use this function!

Recruiting

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers - CA046-006

Updated: 1 December, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 5

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
Biological: Ipilimumab Biological: Nivolumab Drug: BMS-986301
Experimental: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
Biological: Nivolumab Biological: Ipilimumab Drug: BMS-986301
Experimental: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
Biological: Nivolumab Drug: BMS-986301 Biological: Ipilimumab
Experimental: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
Drug: BMS-986301 Biological: Ipilimumab Biological: Nivolumab
Experimental: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
Drug: BMS-986301 Biological: Ipilimumab Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant - Must have experienced radiographically documented progressive disease on or after the most recent therapy - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial Exclusion Criteria: - Primary central nervous system (CNS) malignancy - Other active malignancy requiring concurrent intervention - Uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Email Us

Have questions?
Email Us