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.

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: BMS-986156; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598960

CA009-002

2015-002505-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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295 participants in 5 patient groups

BMS-986156: Dose Escalation

Experimental group

Treatment:

Drug: BMS-986156

BMS-986156 + nivolumab (nivo): Dose Escalation

Experimental group

Treatment:

Drug: BMS-986156

Drug: Nivolumab

BMS-986156: Dose Expansion

Experimental group

Treatment:

Drug: BMS-986156

BMS-986156 + nivolumab (nivo): Dose Expansion

Experimental group

Treatment:

Drug: BMS-986156

Drug: Nivolumab

BMS986156 + Nivo: Cohort Expansion

Experimental group

Treatment:

Drug: BMS-986156

Drug: Nivolumab