Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT02966548
• Recruitment Status: Active, not recruiting
• First Posted: November 17, 2016
• Last Update Posted: November 1, 2021
• Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: November 1, 2016
• First Posted Date: November 17, 2016
• Last Update Posted Date: November 1, 2021
• Actual Study Start Date: January 4, 2017
• Estimated Primary Completion Date: September 8, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 15, 2016)

• Number of adverse events (AE) [ Time Frame: Approximately 2.2 years ]
• Number of serious adverse events (SAE) [ Time Frame: Approximately 2.2 years ]
• Number of deaths [ Time Frame: Approximately 2.2 years ]
• Number of laboratory abnormalities [ Time Frame: Approximately 2.2 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 15, 2016)

• Maximum observed serum concentration (Cmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Time of maximum observed serum concentration (Tmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Trough observed serum concentration (Ctrough) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Concentration at the end of a dosing interval (Ctau) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Total body clearance (CLT) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Volume of distribution at steady state (Vss) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Best overall response (BOR) [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Duration of response (DOR) [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Frequency of positive anti-drug antibody (ADA) to BMS-986016 [ Time Frame: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
• Frequency of positive anti-drug antibody (ADA) to Nivolumab [ Time Frame: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
• Official Title: A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
• Brief Summary: This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cancer

Intervention

• Drug: Relatlimab
  Specified dose on specified days
  Other Name: BMS-986016
• Drug: Nivolumab
  Specified dose on specified days
  Other Names:

  • BMS-936558
  • Opdivo

Study Arms

• Experimental: Monotherapy
  Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation
  Intervention: Drug: Relatlimab
• Experimental: Combination Therapy
  Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
  Interventions:

  • Drug: Relatlimab
  • Drug: Nivolumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 27, 2021): 35
• Original Estimated Enrollment (submitted: November 15, 2016): 27
• Estimated Study Completion Date: September 9, 2022
• Estimated Primary Completion Date: September 8, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Inclusion Criteria:

• Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
• Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
• Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
• Males and Females, ages 20 years or older, inclusive

Exclusion Criteria:

• Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
• Other concomitant malignancies (with some exceptions per protocol)
• Any active autoimmune disease or history of known or suspected autoimmune disease
• History of uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT02966548
• Other Study ID Numbers: CA224-034
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: October 2021