Advanced Solid Malignancies, Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Keywords
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Cancer, Lung Cancer, Kirsten rat sarcoma viral oncogene homolog (KRAS)
Brief 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
DRUGBMS-986523
Specified dose on specified days
DRUGGemcitabine
Specified dose on specified days
DRUGNab-Paclitaxel
Specified dose on specified days
DRUGCetuximab
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator. | Up to 3 years |
| Duration of response (DOR) per RECIST v1.1 as assessed by the investigator. | Up to 3 years |
| Maximum observed plasma concentration (Cmax) | Up to 3 years |
| Time of maximum observed plasma concentration (Tmax) | Up to 3 years |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to 3 years |
Countries
Canada, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed