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.
- Registration Number
- NCT02598960
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
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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
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Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986156: Dose Escalation BMS-986156 - BMS-986156: Dose Expansion BMS-986156 - BMS-986156 + nivolumab (nivo): Dose Expansion BMS-986156 - BMS986156 + Nivo: Cohort Expansion Nivolumab - BMS-986156 + nivolumab (nivo): Dose Expansion Nivolumab - BMS-986156 + nivolumab (nivo): Dose Escalation BMS-986156 - BMS986156 + Nivo: Cohort Expansion BMS-986156 - BMS-986156 + nivolumab (nivo): Dose Escalation Nivolumab -
- Primary Outcome Measures
Name Time Method Number of Participants With Laboratory Abnormalities in Specific Liver Tests From first treatment to 100 days post last dose. Approximately 29 months Number of Participants with laboratory abnormalities in specific liver tests.
ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphataseNumber of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths From first treatment to 100 days post last dose. Approximately 29 months 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.Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests From first treatment to 100 days post last dose. Approximately 29 months Number of Participants with laboratory abnormalities in specific thyroid tests.
TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
- Secondary Outcome Measures
Name Time Method Duration of Response From first dose to disease progression after a response (Approximately 50 Months) All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
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.Number of Participants With Anti-Drug Antibody Response At Cycle 3 Day 1; where each treatment cycle was 8 weeks Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab
Overall Response Rate From first dose to CR and PR (Approximately 50 Months) Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).
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.Best Overall Response From first dose to a response or progressive disease (Approximately 50 Months) 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.Progression Free Survival (PFS) From first dose to disease progression (Approximately 50 Months) The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Progression is defined as 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).
Trial Locations
- Locations (17)
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Local Institution
🇨ðŸ‡Zurich, Switzerland
Linear Clinical Research Ltd
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0012
🇧🇪Gent, Belgium
Institut Claudius Regaud
🇫🇷Toulouse Cedex 9, France
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0015
🇮🇹Milan, Lombardia, Italy
Institut Gustave Roussy
🇫🇷Vlllejuif, France
Local Institution - 0014
🇮🇹Milano, Italy
Cantonal Hospital St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
The West Clinic, P.C.
🇺🇸Germantown, Tennessee, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Liverpool Cancer Therapy Center
🇦🇺Liverpool, New South Wales, Australia