Inclusion Criteria:
- Participants in Part 1 must have histologic or cytologic confirmation of non-small
cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous
cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell
carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma,
that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease
per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced
NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.
- In Part 2, archival biopsy collected within 3 months of screening with no intervening
therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly
cut unstained FFPE slides with an associated pathological report) or fresh biopsy
collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days)
are mandatory, while it is strongly encouraged but optional at progression. Therefore,
the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure,
as judged by the investigator, in order to be eligible for the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants resistant/refractory to or intolerant of existing standard therapies
known to provide clinical benefit (in addition, participants with NSCLC must be
resistant or refractory to anti-PD-(L)1-based immunotherapy)
Exclusion Criteria:
- Participants with primary central nervous system (CNS) disease, or tumors with CNS
metastases as the only disease site, will be excluded. Participants with controlled
brain metastases, however, will be allowed to enroll. Controlled brain metastases are
defined as no radiographic progression for at least 4 weeks following radiation and/or
surgical treatment (or 4 weeks of observation if no intervention is clinically
indicated), no longer taking steroids for at least 2 weeks prior to first dose of
study intervention, and with no new or progressive neurological signs and symptoms.
- Participants with a condition requiring systemic treatment with corticosteroids (> 10
mg daily prednisone equivalent) within 14 days or other immunosuppressive medications
within 30 days of randomization. Inhaled or topical steroids and adrenal replacement
steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of
active autoimmune disease.
- Participants with concurrent malignancy or history of prior malignancy active within 2
years (except history of early-stage basal/squamous cell skin cancer or non-invasive
or in situ cancers who have undergone definitive treatment) are excluded unless
treatment was completed at least 2 years before randomization and the participant has
no evidence of disease.
- Participants with NSCLC with known or not tested for epidermal growth factor receptor
(EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or
anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations
sensitive to available targeted inhibitor therapy
Other protocol-defined inclusion/exclusion criteria apply.
Recruiting
