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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with adverse events (AEs) — Up to 3 years
Number of participants with serious adverse events (SAEs) — Up to 3 years
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria — Up to 3 years
Number of participants with AEs leading to discontinuation — Up to 3 years
Number of deaths — Up to 3 years
Trial sites (8)
Facility
City
Region
Status
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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