Study on Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for Treating Early-Stage Anal Cancer

Inclusion Criteria

• Must provide written consent and agree to share personal health information.
• Be 18 years or older.
• Have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a confirmed diagnosis of early-stage invasive squamous cell carcinoma of the anus.
• Be unable to receive standard treatment with 5-fluorouracil and mitomycin-C with radiation.
• Have not received treatment for anal cancer before.
• Have measurable disease based on specific criteria.
• Provide a tissue sample for analysis, either from previous tests or a new biopsy.
• Have adequate organ function based on blood tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men must agree to use contraception if their partner is of childbearing potential.
• If HIV-positive, must have well-controlled HIV with stable treatment.
• If hepatitis B or C positive, must have the virus under control or cured.
• Must understand and agree to follow study procedures.

Exclusion Criteria

• Have uncontrolled illness or active infection requiring treatment.
• Have another progressing cancer or one that required treatment in the past two years, unless it is a low-risk type.
• Be pregnant or breastfeeding, or planning to conceive or father a child during the study.
• Have active cancer spread to the brain or spinal cord, unless stable after treatment.
• Have severe allergies to pembrolizumab or its ingredients.
• Have an active autoimmune disease needing treatment in the past two years.
• Have an immune deficiency or be on high-dose steroids or other immunosuppressive drugs.
• Have received a live vaccine within 30 days before starting the study.
• Have a history of lung disease requiring steroids.
• Have used an investigational drug or device for anal cancer recently.
• Have had a bone marrow or organ transplant.
• Have not recovered from major surgery or have ongoing complications.
• Have any condition or treatment that might interfere with the study.
• Have psychiatric or substance abuse issues affecting participation.
• Have had prior treatment with certain immune therapies.
• Be on a medication that cannot be stopped or changed before starting the study.