Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Have histologically or cytologically confirmed recurrent/metastatic head and neck
squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies.
Acceptable prior lines of therapy will be determined according to specific cohort 1,
2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral
cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative
(Note: All participants with an oropharyngeal tumor must have results of p16 status,
per local testing); (c) Participants must provide local testing results of
programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (a) Patients
must have primary tumor location in oropharynx. Unknown primary tumors are not
included (b) Primary tumor must be HPV-positive, confirmed by positive p16 test or
high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current
or archival) (c) Participants must provide local testing results of PD-L1 status, if
available
- Participants in Cohorts 1, 2, and 3B and 4 must have measurable disease according to
RECIST version 1.1. Participants in Cohort 3A must have evaluable disease (defined
as having at least 1 non-target lesion according to RECIST version 1.1
- Toxicities from previous anticancer therapies should have resolved to baseline
levels or to Grade 1 or less prior to the first dose of study treatment (except for
alopecia or post-radiation skin changes [any grade], Grade less than or equal to
[<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormone
replacement)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participant must have adequate organ and bone marrow function as follows, without
history of red blood cell transfusion, platelet transfusion, or use of granulocyte
colony-stimulating factor within 7 days prior to the date of the laboratory test.
Participants should have: a) Hemoglobin >=9 grams per deciliter (g/dL); b) Neutrophils
>=1.5 x 10^3/mcg; c) Platelets >=100 x 10^3/mcg
Exclusion Criteria:
- Uncontrolled illness including any medical history or current (non-infectious)
interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected
ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Participant with untreated brain metastases leptomeningeal disease, or spinal cord
compression not definitively treated with surgery or radiation
- Participant with a history of clinically significant cardiovascular disease
- Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment
with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever
is longer, before the first administration of study treatment. The maximum required
washout is 28 days
- Received radiotherapy for palliative purposes within 7 days of the first
administration of study treatment