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Recruiting

An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors - CA044-001

Updated: 01 October, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants 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 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 6

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort Expansion
Drug: BMS-986310 Biological: Nivolumab
Experimental: Dose Escalation
Drug: BMS-986310 Biological: Nivolumab

Key Eligibility Criteria

Inclusion Criteria: - Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy. - ECOG performance status less than or equal to 1 Part 1 and Sub-study B: i) Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible. ii) Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy Sub-study A: i) Males and females with histologically confirmed TNBC as defined by ASCO/CAP guidelines. ii) Participants must be newly diagnosed, no prior history of treatment for TNBC. iii) Tumor size greater than or equal to 1cm3 iv) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor. Part 2 i) Patients with NSCLC ii) Patients with Pancreatic Cancer iii) Patients with TNBC iiii) Patients with CRC Exclusion Criteria: - History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed - Participants with an active, known or suspected autoimmune disease.

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us