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A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

ConditionAdvanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Untreated central nervous system (CNS) metastases.

Leptomeningeal metastasis (carcinomatous meningitis).

Impaired cardiac function or clinically significant cardiac disease.

For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BMS-986488

    Drug

    Specified dose on specified days

  • Adagrasib

    Drug

    Specified dose on specified days

  • Cetuximab

    Drug

    Specified dose on specified days

  • Nivolumab

    Drug

    Specified dose on specified days

Treatment groups

437 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1A: BMS-986488 MonotherapyExperimental treatment 1 intervention
Group B: Part 1B: BMS-986488 + AdagrasibExperimental treatment 2 interventions
Group C: Part 1C: BMS-986488 + Adagrasib + CetuximabExperimental treatment 3 interventions
Group D: Part 1D: BMS-986488 + NivolumabExperimental treatment 2 interventions
Group E: Part 2A: BMS-986488 MonotherapyExperimental treatment 1 intervention
Group F: Part 2B: BMS-986488 + AdagrasibExperimental treatment 2 interventions
Group G: Part 2C: BMS-986488 + Adagrasib + CetuximabExperimental treatment 3 interventions
Group H: Part 2D: BMS-986488 + NivolumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events (AEs)

Time frame
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
2

Number of participants with Serious AEs (SAEs)

Time frame
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
3

Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria

Time frame
From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
4

Number of participants with AEs leading to discontinuation

Time frame
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

Secondary outcomes

1

Maximum observed plasma concentration (Cmax)

Time frame
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
2

Time of maximum observed concentration (Tmax)

Time frame
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
3

Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

Time frame
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
4

Objective response rate (ORR)

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)

Time frame
From time of informed consent up to 52 weeks after end of treatment visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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