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Clinical Trials/EUCTR2015-002505-11-NL
EUCTR2015-002505-11-NLActive, not recruitingPhase 1

A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination with Nivolumab (BMS-936558, anti-PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Bristol-Myers Squibb International Corporation0 sites380 target enrollmentStarted: April 4, 2016Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
380
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •For Dose Escalation:
  • •- Subjects with any previously treated advanced (metastatic or refractory) solid tumor
  • •For Cohort Expansion:
  • •- Subjects must have a previously treated advanced solid tumor to be eligible
  • •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
  • •- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 304
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

  • •- Known central nervous system metastases or central nervous system as the only source of disease
  • •- Other concomitant malignancies (with some exceptions per protocol)
  • •- Active, known or suspected autoimmune disease
  • •- Uncontrolled or significant cardiovascular disease
  • •- History of chronic hepatitis
  • •- History of active hepatitis (B or C)
  • •- Impaired liver or bone marrow function
  • •- Major surgery less than 1 month before start of the study

Investigators

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