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

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ClinicalTrials.gov Identifier: NCT03110107
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : July 12, 2021
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 : 390 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 : May 4, 2017
Estimated Primary Completion Date : March 19, 2023
Estimated Study Completion Date : November 3, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1A: Monotherapy (BMS-986218) Biological: BMS-986218
Specified dose on specified days

Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab) Biological: BMS-986218
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab) Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Biological: BMS-986218
Specified dose on specified days

Experimental: Part 2B: Monotherapy (BMS-986218) Biological: BMS-986218
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
  3. Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 4 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
  5. Incidence of death [ Time Frame: Up to 4 years ]
  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 4 years ]
  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 4 years ]
  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis [ Time Frame: Up to 4 years ]
  9. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  10. Median Duration of Response (mDOR) [ Time Frame: Up to 4 years ]
  11. Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. ORR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
  2. mDOR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
  3. PFS of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
  4. Incidence of anti-drug antibody (ADA) to BMS-986218 [ Time Frame: Up to 4 years ]
  5. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 4 years ]
  6. Time of maximum observed concentration (Tmax) [ Time Frame: Up to 4 years ]
  7. Area under the concentration-time curve from time zero to the time of the [ Time Frame: Up to 4 years ]
  8. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 4 years ]
  9. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 4 years ]
  10. Total body clearance (CLT) [ Time Frame: Up to 4 years ]
  11. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 4 years ]
  12. 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 ]
  13. Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 4 years ]
  14. Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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
  • Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
  • Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Part 2B)
  • Women must agree to follow methods of contraception, if applicable

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 #

Locations
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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    
Other Study ID Numbers: CA022-001
2017-000597-11 ( EudraCT Number )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021

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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
Antineoplastic Agents, Immunological
Antineoplastic Agents