PHASE I STUDY WITH BMS-986458 ALONE AND IN COMBINATION WITH ANTI-LYMPHOMA-4 AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMAS (R/R NHL)
Zusammenfassung der Studie
This is a multicenter, open-label Phase 1 dose-finding study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics, as well as the preliminary efficacy of BMS-986458 alone and in combination with anti-lymphoma agents in participants with R/R NHL. The study consists of two parts: dose escalation (Part A) and dose expansion (Part B). In Part A, the safety and tolerability of BMS-986458 as monotherapy (Part A1) and in combination with Rituximab (Part A2) are investigated to establish the OBD(s) for dose expansion. In Part B, the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMS-986458 alone (Part B1) or in combination with anti-lymphoma agents (Part B2) are further investigated. One or more doses from Part A may be selected for further evaluation in Part B. Additional expansion cohorts, in which other combinations (Part B2) or selected patient groups (Part B3) are studied, may be considered by the sponsor upon recommendation of the SRC. The aim of Part A is to identify one or more safe and tolerable doses for further investigation in Part B. Part B aims to obtain additional safety and preliminary efficacy data on these doses for RP2D determination.
(BASEC)
Untersuchte Intervention
BMS-986458 will be administered orally starting from Day 1 of Cycle 1 in a 28-day cycle for up to 2 years, until clinically significant disease progression or unacceptable toxicity occurs, or until the participant/physician decides to discontinue treatment. Rituximab will be administered according to the package insert and standard practice of the institution at a fixed dose of 375 mg/m2 for a maximum of 6 infusions (Cycles 1–6, Day 1). Survival follow-up will last up to 3 years (156 weeks) from the first treatment. Participants may be enrolled in the study for up to 160 weeks (including screening, treatment, and follow-up).
(BASEC)
Untersuchte Krankheit(en)
Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)
(BASEC)
Main inclusion criteria: Participants ≥ 18 years with R/R NHL (including DLBCL [i.e., DLBCL, not otherwise specified (NOS), and diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements] and FL): · For R/R DLBCL (de novo) and FL 3b: after at least 2 prior lines of therapy (e.g., first-line combination chemotherapy with Rituximab, anthracycline, an alkylating agent, and steroids, and at least one additional treatment). · For R/R DLBCL (transformed lymphoma): after at least 2 prior lines of therapy, which must have been administered after transformation. · For R/R FL (except for FL 3b): after at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment in the study as assessed by the investigator. The participant must have measurable disease (defined by at least one FDG-avid lesion in FDG-avid disease and a two-dimensional measurable disease on cross-sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter); additionally, a plan for pregnancy prevention must be accepted and followed. Main exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3; (BASEC)
Ausschlusskriterien
Key exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3; inability to comply with specified restrictions, precautions, and prohibited treatments; prior CAR-T, cereblon-modulating agents, or radiotherapy ≤ 4 weeks ago, systemic cancer treatment ≤ 5 half-lives or 4 weeks ago, allogeneic SCT ≤ 6 months ago, or autologous SCT ≤ 3 months before start of study intervention; any condition, including relevant acute or chronic diseases, active or uncontrolled infections, or abnormal laboratory findings, that places participants at unacceptable risk if they participate in the study; known or suspected central nervous system involvement. (BASEC)
Studienstandort
Basel, Bellinzona, Genf
(BASEC)
Sponsor
Dr. Carmen Lilla Bristol Myers Squibb SA Hinterbergstrasse 16 6312 Steinhausen carmen.lilla@bms.com +41 79 544 22 77
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Fatime Krasniqi
0041612655074
Fatime.Krasniqi@clutterusb.chUniversity Hospital Basel- Oncology Petersgraben 4 4031 Basel
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
02.05.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
CA123-1000: A Phase 1, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination with Anti-lymphoma Agents in Participants with Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL) (BASEC)
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