NCT02737475 | Study Connect

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Recruiting

An Investigational Immuno-therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Patients With Solid Cancers That Are Advanced or Have Spread - CA012-004

Updated: 02 October, 2018 | ClinicalTrials.gov

About This Trial
Key Eligibility Criteria
Trial Site Locations

Print Friendly Summary

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.

Print this page CA012-004

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SELECT LANGUAGE

Trial Details

Phase 1/Phase 2

Phase
Gender(s)
18+

Age Range
18

Location(s)
Recruiting

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Experimental: Part 1: Dose Escalation

Drug: BMS-986178

Experimental: Part 2: Dose Escalation and Expansion

Drug: Nivolumab Drug: BMS-986178

Experimental: Part 3: Dose Escalation and Expansion

Drug: BMS-986178 Drug: Ipilimumab

Experimental: Part 4: Dose Schedule and Exploration

Drug: BMS-986178 Drug: Nivolumab

Experimental: Part 5: Dose Schedule and Exploration

Drug: Ipilimumab Drug: BMS-986178

Experimental: Part 6: Dose Safety and Expansion

Drug: BMS-986178 Drug: Nivolumab Drug: Ipilimumab

Experimental: Part 7: Dose Safety and Expansion

Drug: BMS-986178 Drug: Nivolumab Drug: Ipilimumab

Experimental: Part 8: Dose Schedule and Exploration

Drug: BMS-986178 Drug: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Patients must have at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting - ECOG (Eastern Cooperative Oncology Group) 0-1 - Men and women 18 years old or older - At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1 - All subjects must have a fresh tumor biopsy Exclusion Criteria: - Known central nervous system metastases or central nervous system as the only source of disease - Concomitant malignancies - Active known or suspected autoimmune disease - Uncontrolled or significant cardiovascular disease - Major surgery less than 4 weeks before the start of the study - Patients with known allergies to egg products, neomycin, or tetanus toxoid - Prior adverse reaction to tetanus toxoid-containing vaccines Other protocol defined inclusion/exclusion criteria could apply

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