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

Summary

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

Interventions

• 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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
* Other protocol-defined Inclusion/Exclusion criteria apply.

Sites (8)

• Johns Hopkins Hospital, Baltimore, Maryland · Recruiting
• NEXT Oncology, San Antonio, Texas · Recruiting
• START Mountain Region, West Valley City, Utah · Recruiting
• NEXT Virginia, Fairfax, Virginia · Recruiting
• BC Cancer Vancouver, Vancouver, British Columbia · Recruiting
• Princess Margaret Cancer Centre, Toronto, Ontario · Recruiting
• Local Institution - 0006, Badalona, Barcelona [Barcelona] · Not yet recruiting
• Local Institution - 0008, Hortaleza, Madrid · Not yet recruiting