Phase 2
N=106
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
Hematologic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02061761 ↗Enrolled (actual)
106
Serious AEs
44.3%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation — 3; 9; 5; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986016 (Biological); BMS-936558 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation |
3; 9; 5; 19; 7; 1 | — |
| PRIMARY Number of Participants Who Died |
0; 2; 1; 2; 2; 0 | — |
| PRIMARY Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Objective Response Rate (ORR) - Part D |
61.9; 6.7; 15.0 | — |
| PRIMARY Duration of Response (DoR) - Part D |
14.16; NA; 6.37 | — |
| SECONDARY BMS-986016 Maximum Observed Serum Concentration (Cmax) |
3.697; 22.738; 224.802; 68.718; 19.990; 57.900 | — |
| SECONDARY BMS-986016 Time of Maximum Observed Serum Concentration (Tmax) |
0.97; 1.300; 4.167; 1.825; 3.950; 0.97 | — |
| SECONDARY BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) |
401.438; 2852.533; 44296.525; 9086.827; 2908.011; 9480.758 | — |
| SECONDARY BMS-986016 Concentration at the End of a Dosing Interval (Ctau) |
0.158; 1.037; 75.589; 12.221; 3.848; 19.500 | — |
| SECONDARY BMS-986016 Effective Elimination Half-life That Explains the Degree of AUC Accumulation Observed (T 1/2eff AUC) |
240.671; 742.843; 547.986; 428.698; 548.741; 720.317 | — |
| SECONDARY BMS-986016 Total Body Clearance (CL/T) |
28.074; 16.333; 4.535; 12.777; 12.974; 6.942 | — |
| SECONDARY BMS-986016 Cmax Accumulation Index (AI_Cmax) |
1.981; 1.701; 2.009; 1.734; 2.369; 2.573 | — |
| SECONDARY BMS-986016 Accumulation Index (AI_AUC) |
1.577; 1.850; 2.894; 2.186; 2.017; 3.647 | — |
| SECONDARY BMS-986016 Ctau Accumulation Index (AI_Ctau) |
0.743; 2.494; 4.741; 2.310; 1.686; 5.282 | — |
| SECONDARY BMS-986016 Average Concentration Over a Dosing Interval ([AUC(TAU)/Tau] (Css,Avg) |
2.117; 14.738; 526.269; 57.790; 18.345; 103.805 | — |
| SECONDARY BMS-986016 Trough Observed Serum Concentration (Ctrough) |
0.064; 1.457; 75.589; 12.221; 3.848; 19.500 | — |
| SECONDARY Number of Participants With Anti-BMS-986016 Antibodies (ADA) |
0; 1; 1; 6; 0; 0 | — |
| SECONDARY Number of Participants With Anti-Nivolumab Antibodies (ADA) |
0; 0; 0; 0; 0; 1 | — |
Summary
The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)
Eligibility Criteria
Inclusion Criteria
- Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment
- Must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, alemtuzumab, or anti-CD30) therapy.
- Must be more than 100 days post autologous transplant
Exclusion Criteria
- Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed)
- Known or suspected autoimmune disease
- History of allergy to anti-PD-1 or anti-PD-L1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02061761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.