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First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03110107
First received: April 7, 2017
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Condition Intervention Phase
Advanced Cancer
Biological: Ipilimumab
Biological: BMS-986218
Biological: 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: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 3 years ]
    Safety and tolerability as measured by incidence of AEs

  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]
    Safety and tolerability as measured by incidence of SAEs

  • Objective Response Rate (ORR) of BMS-986218 monotherapy relative to Ipilimumab in immuno-oncology (IO) progressed melanoma cohort [ Time Frame: Up to 3 years ]
    Assessment of preliminary efficacy and safety of BMS-986218 monotherapy relative to ipilimumab

  • Median Duration of Response (mDOR) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort [ Time Frame: Up to 3 years ]
    Assessment of preliminary efficacy and safety of BMS-986218 monotherapy relative to ipilimumab

  • Progression Free Survival (PFS) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort [ Time Frame: Up to 3 years ]
    Assessment of preliminary efficacy and safety of BMS-986218 monotherapy relative to ipilimumab


Secondary Outcome Measures:
  • ORR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 3 years ]
    Assessment of preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors

  • mDOR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 3 years ]
    Assessment of preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors

  • PFS of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 3 years ]
    Assessment of preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors

  • Incidence of anti-drug antibody (ADA) to BMS-986218 [ Time Frame: Up to 3 years ]
    Summary measures of pharmacokinetics (PK) parameters and incidence of ADA to BMS-986218

  • Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 3 years ]
    Summary measures of Tregs and correlation/measure of association of anti-tumor activity and change (or % change) from baseline in Tregs

  • Maximum observed serum concentration (Cmax) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Time of maximum observed concentration (Tmax) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Area under the concentration-time curve from time zero to the time of the [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Trough observed serum concentration (Ctrough) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Total body clearance (CLT) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters

  • Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 3 years ]
    Summary measures of PK parameters


Estimated Enrollment: 531
Anticipated Study Start Date: April 28, 2017
Estimated Study Completion Date: March 17, 2021
Estimated Primary Completion Date: April 5, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy
Ipilimumab Monotherapy and BMS-986218 Monotherapy
Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy
Biological: BMS-986218
Specified dose on specified days
Experimental: Combination Therapy
BMS-986218 in combination with Nivolumab
Biological: BMS-986218
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Participants must have received, and then progressed, relapsed, or been intolerant to, all standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists

Exclusion Criteria:

  • Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

Other protocol defined inclusion/exclusion criteria could apply

  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: NCT03110107

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 #

Locations
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0003         
United States, Nevada
Local Institution Not yet recruiting
Las Vegas, Nevada, United States, 89128
Contact: Site 0005         
United States, New Jersey
Local Institution Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site 0002         
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10032
Contact: Site 0001         
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0004         
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: NCT03110107     History of Changes
Other Study ID Numbers: CA022-001
2017-000597-11 ( EudraCT Number )
Study First Received: April 7, 2017
Last Updated: April 24, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Antibodies
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 27, 2017