An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

• Status: Completed
• Trial end date: 2020-12-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

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 active or chronic hepatitis (e.g. Hep B or C)

• Impaired liver or bone marrow function

• Major surgery less than 1 month before start of the study