Non-Melanoma Skin Cancers

Head and Neck Cancer
Non-Melanoma Skin Cancers
- Advanced Unresectable/Metastatic
  - Cutaneous SCC
  - VICCPHI2254
    PH1/1b, OL BCA101 Monotherapy & In Combination Therapy Pts w/EGFR-Driven Advanced Solid Tumors
    - Eligibility Criteria
      Inclusion Criteria:
      1. Single agent BCA101 - patients with the following tumor type will be eligible:
      a. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
      2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
      a. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
      b. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
      c. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
      d. Patients must have progressed on one prior systemic therapy in the metastatic setting.
      e. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
      f. Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
      3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab -Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
      
      Exclusion Criteria:
      1. Prior treatment with any anti-TGFb therapy.
      2. Has a history of (non-infectious) pneumonitis, radiation pneumonitis or interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
      
      For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
  - Basal Cell
    - VICCHN24568
      Phase II Fianlimab+Cemiplimab vs Cemiplimab in First Line Treatment PD-L1 Positive R/M HNSCC
      - 1. Histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies.
        2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary will be eligible only if documented to be HPV positive).
        3. PD-L1 expression CPS ≥1 documented with a previously PD-L1 obtained IHC result prior to screening, based on a surgical specimen or a core biopsy specimen from any site of HNSCC in a CAP/CLIA lab. (Stratification factor).
        4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical specimen or a core biopsy specimen from any site of OPSCC as follows:
        -For OPSCC, either of the following will be accepted as evidence of HPV-positive OPSCC: positive p16 IHC or positive HPV DNA or RNA ISH.
        -SCC of neck node with occult primary permitted if positive HPV DNA or RNA ISH in cervical node specimen and will be classified as having HPV positive oropharynx cancer.
        5. ECOG 0 or 1.
- Locoregionally Advanced
  - Cutaneous SCC
  - Basal Cell