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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

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ClinicalTrials.gov Identifier: NCT03110107
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Cancer Biological: Ipilimumab Biological: BMS-986218 Biological: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : November 3, 2023
Estimated Study Completion Date : November 3, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ipilimumab Monotherapy
Ipilimumab Monotherapy
Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

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

Experimental: BMS-986218 Monotherapy
BMS-986218 Monotherapy
Biological: BMS-986218
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
    Safety and tolerability as measured by incidence of SAEs

  3. Objective Response Rate (ORR) of BMS-986218 monotherapy relative to Ipilimumab in immuno-oncology (IO) progressed melanoma cohort [ Time Frame: Up to 4 years ]
    Assessment of preliminary efficacy and safety of BMS-986218 monotherapy relative to ipilimumab

  4. Median Duration of Response (mDOR) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort [ Time Frame: Up to 4 years ]
    Assessment of preliminary efficacy and safety of BMS-986218 monotherapy relative to ipilimumab

  5. Progression Free Survival (PFS) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort [ Time Frame: Up to 4 years ]
    Assessment of preliminary efficacy and safety of BMS-986218 monotherapy relative to ipilimumab


Secondary Outcome Measures :
  1. ORR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
    Assessment of preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors

  2. mDOR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
    Assessment of preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors

  3. PFS of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
    Assessment of preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors

  4. Incidence of anti-drug antibody (ADA) to BMS-986218 [ Time Frame: Up to 4 years ]
    Summary measures of pharmacokinetics (PK) parameters and incidence of ADA to BMS-986218

  5. Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 4 years ]
    Summary measures of Tregs and correlation/measure of association of anti-tumor activity and change (or % change) from baseline in Tregs

  6. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  7. Time of maximum observed concentration (Tmax) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  8. Area under the concentration-time curve from time zero to the time of the [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  9. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  10. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  11. Total body clearance (CLT) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  12. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  13. 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 4 years ]
    Summary measures of PK parameters

  14. Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  15. Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 4 years ]
    Summary measures of PK parameters

  16. Time to deterioration (TTD) in Quality of Life and physical functioning [ Time Frame: Up to 4 years ]
    Patient-reported outcomes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 at least 2 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110107


Contacts
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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 27 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03110107     History of Changes
Other Study ID Numbers: CA022-001
2017-000597-11 ( EudraCT Number )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents