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A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

ConditionsAdvanced Solid MalignanciesNon-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).

Participants must, for Arm D, have a PD-L1 expression (≥50%).

Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.

Disqualifiers

Participants must not have untreated central nervous system (CNS) metastases.

Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.

Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.

Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986523

    Drug

    Specified dose on specified days

  • Gemcitabine

    Drug

    Specified dose on specified days

  • Nab-Paclitaxel

    Drug

    Specified dose on specified days

  • Cetuximab

    Drug

    Specified dose on specified days

  • Pembrolizumab

    Drug

    Specified dose on specified days

Treatment groups

252 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CExperimental treatment 1 intervention
Group D: Arm DExperimental treatment 2 interventions
Group E: Arm EExperimental treatment 2 interventions
Group F: Arm FExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 3 years
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to 3 years
3

Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria

Time frame
Up to 3 years
4

Number of participants with AEs leading to discontinuation

Time frame
Up to 3 years

Secondary outcomes

1

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.

Time frame
Up to 3 years
2

Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.

Time frame
Up to 3 years
3

Maximum observed plasma concentration (Cmax)

Time frame
Up to 3 years
4

Time of maximum observed plasma concentration (Tmax)

Time frame
Up to 3 years

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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