A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

This is an interventional treatment trial for HPV-Related Squamous Cell Carcinoma focused on measuring Vaccine, Gene Therapy, TheraT®, E7E6, HPV 16 E7E6, HNSCC, HPV 16+ head and neck squamous cell cancer, Oropharyngeal cancer, HPV16, HPV 16, Head and neck cancer, Carcinoma, Carcinoma, squamous cell, Squamous cell carcinoma of head and neck, Neoplasms, squamous cell, Head and neck neoplasms, Pembrolizumab Read More

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 1, Group 3, Group 5, Group 6, Group A, or Group D:

• Documentation of confirmed head and neck squamous cell carcinoma.
• Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy.

Treatment Group 2, Group 4, Group C, or Group F:

• Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy.

Treatment Group B or Group E:

• Documentation of confirmed head and neck squamous cell carcinoma.
• Eligible to receive pembrolizumab, per standard of care and product label. Note: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.

Anal Cancer Cohort:

• Documentation of confirmed HPV 16+ locally advanced or metastatic SCC of anal canal.
• 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:

• Untreated and/or symptomatic metastatic central nervous system disease, unless protocol-defined criteria is met.
• 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 is met.
• Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
• 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 or other severe reaction to human immunoglobulin or antibody formulation administration.
• 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 B or E and certain backfill cohorts:

• History of severe hypersensitivity reaction to or other contraindication to receiving immune checkpoint inhibitor.
• Allogenic tissue/solid organ transplant.
• History of/Presently having non-infectious pneumonitis requiring treatment.

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 1 or Group 3