Expanded Access Program for VO (RP1) and Nivolumab in Patients with Advanced Melanoma

Sponsor: Replimune Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06590480

Provider View

This program offers access to a new treatment combination of VO (RP1) and nivolumab for patients with advanced melanoma who might benefit from it, even before it is officially approved for general use.

Patient Parameters

Program Overview

The goal of this program is to provide patients with advanced melanoma access to a new treatment that combines VO (RP1) and nivolumab. This combination aims to directly attack and reduce tumors while boosting the body's immune response to fight cancer. It is intended for patients whose melanoma has not responded well to previous treatments, particularly those who have progressed on anti-PD-1 therapies. By combining VO with nivolumab, the treatment hopes to increase the number of immune cells that can target the cancer and improve patient outcomes.

Description

This program is designed to help patients with advanced melanoma by offering a new treatment option that combines VO (RP1) and nivolumab. VO works by using a virus to attack cancer cells directly and stimulate the immune system to fight the cancer more effectively. Nivolumab is an anti-PD-1 therapy that helps the immune system stay active against cancer cells. Together, these treatments aim to enhance the body's ability to fight melanoma, especially in patients who have not had success with other treatments. The program is based on research showing that this combination can reduce tumor size more effectively than either treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery or has spread to other parts of the body.
  • Previously treated with an anti-PD-1 therapy.
  • Have at least one tumor that can be measured and injected.
  • Have good blood, liver, and kidney function based on specific medical tests.
  • Have a life expectancy of at least 3 months.
  • Agree to use effective birth control during and after treatment.
  • Women must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Previously participated in a specific clinical trial (IGNYTE3 trial).
  • Treated with more than two different systemic therapies for advanced melanoma.
  • Have certain viral infections like hepatitis B, hepatitis C, or HIV unless effectively treated.
  • Have active or significant herpes infections.
  • Have active brain metastases unless treated and stable.
  • Have serious heart conditions or other major health issues.
  • Have a history of severe immune-related side effects from previous treatments.
  • Currently taking high doses of steroids or other immunosuppressive medications.
  • Have received a live vaccine recently.
  • Participating in another clinical trial or taking investigational drugs recently.
  • Have allergies to the study drugs or their components.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.