Early Access Program for Retifanlimab with Carboplatin and Paclitaxel for Anal Canal Cancer

Inclusion Criteria

• Must be able to understand and sign a consent form for the study.
• Must be 18 years or older.
• Must have a confirmed diagnosis of inoperable, locally recurrent, or metastatic squamous carcinoma of the anal canal.
• Must be in good enough health to benefit from the treatment, as determined by a performance status test.
• If HIV-positive, must have a stable condition, be on antiretroviral therapy, and have no recent HIV-related infections.
• Must agree to avoid pregnancy or fathering children during and after the study, using highly effective birth control methods.
  • Men must use birth control and avoid donating sperm during the study and for a specified period after the last dose.
  • Women of childbearing potential must have a negative pregnancy test before starting and use birth control during the study and for a specified period after the last dose.
  • Women who cannot become pregnant are eligible.

Exclusion Criteria

• Have received previous treatment targeting PD-(L)1.
• Have not fully recovered from previous cancer treatments.
• Have certain blood, liver, or kidney test results outside the specified safe range.
• Have active autoimmune diseases requiring high doses of steroids.
• Have lung disease or non-infectious lung inflammation.
• Have had an organ transplant.
• Have active cancer spread to the brain or spinal cord.
• Have active hepatitis A, B, or C infections.
• Have active infections needing treatment or recent IV antibiotic use.
• Have allergies to platinum, paclitaxel, or similar drugs that cannot be managed.
• Have significant heart problems.
• Are pregnant or breastfeeding.
• Have severe nerve damage.
• Have any condition that would prevent full participation in the study or pose a risk to the participant.