After enrollment, your medical condition will be assessed and you will be assigned to one of two treatment groups through a random process.

You will provide a tissue sample from your tumor. This can be either an archived sample collected within 90 days before starting treatment, or a fresh sample taken during this period.

Blood tests will be performed to check your blood cell counts, liver function, kidney function, and blood clotting ability.

If you are a woman of childbearing potential, a pregnancy test will be conducted within 72 hours before the first dose and again on the day of the first dose.

You will receive one of two treatment combinations based on your assigned group.

Group 1 receives RP2 injected directly into the tumor combined with nivolumab given through a vein.

Group 2 receives ipilimumab given through a vein combined with nivolumab given through a vein.

The study medication RP2 is injected directly into at least one tumor that measures 1 centimeter or larger. This tumor must be suitable for repeated injections and must not have been previously treated with surgery, radiation, or other local treatments.

The study medication nivolumab is given as an infusion into a vein at a concentration of 10 milligrams per milliliter.

The study medication ipilimumab is given as an infusion into a vein at a concentration of 5 milligrams per milliliter.

The specific dosage amounts, frequency of administration, and duration of treatment will be determined according to the study protocol for your assigned treatment group.

Throughout the treatment period, you will undergo regular medical examinations and tests to monitor your response to treatment and any side effects.

Imaging scans will be performed at scheduled intervals to measure the size of your tumors and assess whether the disease is progressing, staying stable, or shrinking.

Blood samples will be collected regularly to monitor your overall health, including blood cell counts, liver function, kidney function, and other laboratory values.

Your physical condition will be assessed using the ECOG performance status scale, which measures your ability to carry out daily activities.

Any side effects or health changes you experience will be documented and evaluated by the medical team.

If you are a woman of childbearing potential, you must use highly effective birth control methods during treatment and for at least 5 months after your last dose of nivolumab, or 3 months after your last dose of ipilimumab, or 90 days after your last dose of RP2, whichever period is longest.

If you are a male patient, you must use a condom during sexual intercourse and your partner should also use highly effective birth control during treatment and for at least 90 days after your last dose of RP2.

Male patients must not donate semen during treatment and for 90 days after the last dose of RP2.

If you are taking blood-thinning medications, specific adjustments will be required around the time of RP2 injections and tissue sample collections.

For preventive doses of blood thinners, these medications must be temporarily stopped for an appropriate time before and after each RP2 injection and tissue sample collection.

For therapeutic doses of blood thinners, your treatment may need to be interrupted or the dose decreased as medically appropriate around the time of RP2 injections and tissue sample collections.

Your blood clotting ability will be monitored through laboratory tests to ensure it is within safe limits before procedures.

Treatment will continue according to the study schedule until your disease progresses, unacceptable side effects occur, or other reasons for stopping treatment arise.

The study will monitor your overall survival, which is the time from when you were assigned to a treatment group until death from any cause.

The study will also monitor your progression-free survival, which is the time from when you were assigned to a treatment group until your disease worsens or death occurs.

Other measures being evaluated include the proportion of patients whose tumors shrink, how long any tumor shrinkage lasts, and the proportion of patients whose disease remains stable or improves.

The study is expected to continue until February 2030.