Study on Lenvatinib and Pembrolizumab for Treating Worsening Anal or Rectum Cancer After Initial Treatment

Inclusion Criteria

• Must be 18 years or older and able to provide written consent.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have a confirmed diagnosis of anorectal squamous cell carcinoma.
• Cancer must be advanced or has spread and not removable by surgery, and must have worsened after initial chemotherapy or chemoradiation.
• Must have measurable cancer based on specific criteria.
• Must have adequate organ function as shown by specific blood tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
• Men must agree to use effective contraception if their partner is a woman of childbearing potential.
• Participants with hepatitis B or C must have controlled viral loads and be on appropriate antiviral therapy.
• HIV-positive participants must have well-controlled HIV on antiretroviral therapy.
• Must have controlled blood pressure.
• Must be able to understand and comply with study procedures.

Exclusion Criteria

• Have an active infection requiring treatment.
• Have received certain prior cancer therapies or treatments within a specified time before the study.
• Have received a live vaccine recently.
• Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive therapy.
• Have another progressing cancer or have had active treatment for another cancer in the past 3 years.
• Have active brain metastases or certain severe allergies.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a history of lung disease requiring steroids.
• Have any condition that might interfere with the study or is not in the participant's best interest.
• Have psychiatric or substance abuse disorders affecting study participation.
• Are pregnant, breastfeeding, or planning to conceive during the study.
• Have had a recent major surgery or certain heart conditions.
• Have gastrointestinal issues affecting drug absorption.
• Have active bleeding in the lungs.