A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- Conditions
- Advanced Malignant Tumors
- Interventions
- Registration Number
- NCT06764771
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 437
-
Participant must be ≥ 18 years of age.
-
Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
-
Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
-
Parts 2A, 1D, 2D: ccRCC.
i) Part 1B: solid tumors with KRAS G12C mutation.
ii) Part 2B: NSCLC with KRAS G12C mutation.
iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
- Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
- Participants must have measurable disease per RECIST v1.1.
-
Untreated central nervous system (CNS) metastases.
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Leptomeningeal metastasis (carcinomatous meningitis).
-
Impaired cardiac function or clinically significant cardiac disease.
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For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.
i) History of pneumonitis or interstitial lung disease (ILD).
ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1B: BMS-986488 + Adagrasib Adagrasib - Part 1C: BMS-986488 + Adagrasib + Cetuximab Adagrasib - Part 1C: BMS-986488 + Adagrasib + Cetuximab Cetuximab - Part 1D: BMS-986488 + Nivolumab Nivolumab - Part 2B: BMS-986488 + Adagrasib BMS-986488 - Part 2B: BMS-986488 + Adagrasib Adagrasib - Part 2C: BMS-986488 + Adagrasib + Cetuximab Adagrasib - Part 2C: BMS-986488 + Adagrasib + Cetuximab Cetuximab - Part 2D: BMS-986488 + Nivolumab Nivolumab - Part 1A: BMS-986488 Monotherapy BMS-986488 - Part 1B: BMS-986488 + Adagrasib BMS-986488 - Part 1C: BMS-986488 + Adagrasib + Cetuximab BMS-986488 - Part 1D: BMS-986488 + Nivolumab BMS-986488 - Part 2A: BMS-986488 Monotherapy BMS-986488 - Part 2C: BMS-986488 + Adagrasib + Cetuximab BMS-986488 - Part 2D: BMS-986488 + Nivolumab BMS-986488 -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) Number of participants with Serious AEs (SAEs) Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days) Number of participants with AEs leading to discontinuation Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) Number of deaths From time of informed consent up to 52 weeks after end of treatment visit
- Secondary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Until Cycle 4, Day 1 (1 Cycle = 28 Days) Time of maximum observed concentration (Tmax) Until Cycle 4, Day 1 (1 Cycle = 28 Days) Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Until Cycle 4, Day 1 (1 Cycle = 28 Days) Objective response rate (ORR) From time of informed consent up to 52 weeks after end of treatment visit Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Disease control rate (DCR) From time of informed consent up to 52 weeks after end of treatment visit Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1
Duration of response (DOR) From time of informed consent up to 52 weeks after end of treatment visit Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first
Related Research Topics
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Trial Locations
- Locations (8)
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0020
🇺🇸Allentown, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center
🇺🇸Germantown, Tennessee, United States
Local Institution - 0025
🇺🇸Dallas, Texas, United States
Local Institution - 0031
🇦🇺Brisbane, Queensland, Australia
BC Cancer Vancouver
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0015
🇨🇦Montréal, Quebec, Canada
Local Institution - 0016
🇨🇦Quebec City, Quebec, Canada