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A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors
This study is currently recruiting participants.
Verified May 2017 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02598960
First received: October 21, 2015
Last updated: May 30, 2017
Last verified: May 2017
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Purpose
The purpose of this study is to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of BMS-986156 when administered alone and in combination with nivolumab in subjects with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
| Solid Tumors | Drug: BMS-986156 Drug: Nivolumab | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety of BMS-986156 based on number of incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths in addition to clinical laboratory test abnormalities [ Time Frame: Up to 30 days after the last dose of study drug ]
Secondary Outcome Measures:
- Objective response rate (ORR) [ Time Frame: Approximately 3 years ]ORR is defined as the proportion of all treated subjects whose best overall response is either a complete response (CR) or partial response (PR)
- Progression free survival rate (PFSR) [ Time Frame: Approximately 3 years ]
- Duration of response [ Time Frame: Approximately 3 years ]Duration of response is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first
- Maximum observed concentration (Cmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Time of maximum observed concentration (Tmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Anti-drug antibody (ADA) response to BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Anti-drug antibody response to BMS-986156 and Nivolumab [ Time Frame: Day 1 to 56 days ]
| Estimated Enrollment: | 380 |
| Actual Study Start Date: | October 9, 2015 |
| Estimated Study Completion Date: | May 24, 2018 |
| Estimated Primary Completion Date: | May 23, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mono therapy - BMS-986156 (Dose Escalation)
BMS-986156 dose as specified
|
Drug: BMS-986156 |
|
Experimental: Combination therapy - BMS-986156 + Nivolumab (Dose Escalation)
BMS-986156 + Nivolumab dose as specified
|
Drug: BMS-986156 Drug: Nivolumab |
|
Experimental: Mono therapy - BMS-986156 (Dose Expansion)
BMS-986156 dose as specified
|
Drug: BMS-986156 |
|
Experimental: Combination therapy - BMS-986156 + Nivolumab (Dose Expansion)
BMS-986156 + Nivolumab dose as specified
|
Drug: BMS-986156 Drug: Nivolumab |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02598960
Show 28 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02598960
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: | Clinical.Trials@bms.com | ||
| Contact: First line of the email MUST contain NCT# and Site #. |
Show 28 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02598960 History of Changes |
| Other Study ID Numbers: |
CA009-002 2015-002505-11 ( EudraCT Number ) |
| Study First Received: | October 21, 2015 |
| Last Updated: | May 30, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Nivolumab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017