Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria
All Patients:
- Documentation of confirmed HPV 16+ cancer via genotype testing.
- ≥ 1 measurable lesion by imaging for tumor response following RECIST
- ECOG performance status of 0 to 1.
- Prior curative radiation therapy and prior focal palliative completed per
protocol-specified wash-out windows.
- Screening laboratory values must meet protocol-specified criteria.
- Able to provide tumor tissue following last treatment, unless otherwise agreed.
Treatment Group E or Group F:
- Documentation of confirmed head and neck squamous cell carcinoma.
- Eligible to receive pembrolizumab, per standard of care and product label.
- Group E: this group includes first line / 1L patients who have not yet received
treatment in the metastatic/recurrent setting.
- Group F: Tumor progression or recurrence on standard of care therapy, including ≥1
systemic therapy.
Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center
only):
- Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
- At least 1 non-irradiated measurable lesion documented through imaging.
Exclusion Criteria:
All patients:
- Metastatic central nervous system disease, and/or carcinomatous meningitis.
- Any serious or uncontrolled medical disorder that, in the opinion of the
Investigator, may increase the risk associated with study participation / treatment
administration.
- Concurrent malignancy that is clinically significant or requires active
intervention, unless protocol-defined criteria are met.
- Active, known or suspected, autoimmune or inflammatory disorders requiring
immunosuppressive therapy.
- Has a life expectancy of less than 3 months.
- Any toxicities attributed to systemic prior anticancer therapy o that have not
resolved to Grade 1 or baseline prior to the first administration of study drug,
unless protocol-defined criteria is met.
- Not meeting the protocol-specified washout periods for prohibited medications.
- Prior anaphylactic reaction to or known allergy or hypersensitivity to
investigational product(s) or any of the excipients of the investigational
product(s).
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody,
indicating acute or chronic infection.
- Known history of acquired immunodeficiency syndrome.
For patients in Groups E or F and certain backfill cohorts:
- History of severe hypersensitivity reaction to or other contraindication to
receiving pembrolizumab.
- History of/Presently having non-infectious pneumonitis requiring treatment.
- Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving
prior therapy with check point inhibitors.
Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center
only):
- Having splenic disorders or prior splenectomy, and can compromise protocol
objectives per Investigator and/or Sponsor.
- Meeting requirements of exclusion criteria for Treatment Group 3
