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Randomized Phase II Trial of Neoadjuvant Opdualag Versus Nivolumab for Resectable High-risk Basal Cell Carcinoma

Cancer
Poorva Vaidya
Other Skin

Study Description

This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk BCC (HR BCC)

Eligibility

  1. Histologically or cytologically confirmed basal cell carcinoma (BCC)
  2. Subjects must have treatment naive BCC
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate Organ Function as defined by protocol
  5. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the patient has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or non invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
  6. Women of Childbearing Potential are eligibile to enroll in Cohort 1 IF they agree to use highly-effective methods of contraception with low user-dependency during treatment and for at most up to 5 months post-treatment completion, or Cohort 2 IF they present a negative serum/urine pregnancy test with up to 72 hours prior to receipt of 1st dose of study treatment.

Key

  1. Subjects are currently receiving ANY other investigational therapies/treatments/device, or has participated in a study using an investigational therapy/treatment/device and received said therapy/treatment/device within 4 weeks of receiving the 1st study treatment dose.
  2. Known hypersensitivity to Opdualag, nivolumab, or any of their mediums of administration.
  3. Presence of untreated Central Nervous System metastases
  4. Presence of leptomeningeal metastatic disease
  5. Radiation therapy with 2 weeks of receiving the 1st study treatment dose. Subjects must have recovered from radiation toxicities (at most Grade 1 or at baseline) prior to treatment.
  6. Active, known, or suspected autoimmune disease, with some protocol-defined exceptions
  7. Severe uncontrolled cardiac disease within 6 months of screening, or any prior history of myocarditis or current myocarditis
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