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 Squibb295 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

295

Conditions

Solid Tumors

Interventions

BMS-986156DRUG

NivolumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

University Of Alabama At Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths

Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.

Time frame: From first treatment to 100 days post last dose. Approximately 29 months

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number

Time frame: From first treatment to 100 days post last dose. Approximately 29 months

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase

Time frame: From first treatment to 100 days post last dose. Approximately 29 months

Secondary Outcomes

Best Overall Response

BOR will be defined by CR, PR, PD and SD Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Data from ClinicalTrials.gov

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