Study on Ceralasertib Alone and with Durvalumab for Melanoma Resistant to PD-(L)1 Treatment

Inclusion Criteria

• Have a confirmed diagnosis of melanoma that cannot be removed by surgery or has spread to other parts of the body.
• Have a tumor sample available from a previous biopsy and agree to a new biopsy at the start of the study.
• Have received at least one prior immunotherapy treatment, such as anti-PD-(L)1, with or without anti-CTLA-4, for at least 6 weeks, but no more than two different treatments for advanced cancer.
• Have shown cancer progression during treatment with a PD-(L)1 inhibitor, with or without a CTLA-4 inhibitor.
• Have at least 14 days between the last dose of previous cancer treatments and the first dose of the study treatment.
• Have measurable cancer according to specific medical criteria.
• Have a life expectancy of at least 3 months.
• For the biopsy sub-study, agree to provide three tumor biopsies.

Exclusion Criteria

• Have not had any severe side effects that led to stopping previous checkpoint inhibitor treatments permanently.
• Have not had another type of cancer, unless it was treated successfully and has been inactive for at least 3 years.
• Do not have uveal melanoma (a type of eye cancer).
• Have not had severe immune-related side effects from previous immunotherapy, especially affecting the nervous system or eyes.
• Do not have serious heart conditions, such as heart failure or uncontrolled heart rhythm problems, unless controlled by medication or devices.
• Have not had an organ transplant that requires ongoing use of immune-suppressing drugs.
• Have adequate bone marrow, liver, and kidney function.
• Do not have active infections requiring treatment, including hepatitis or COVID-19, unless fully recovered.