Study Comparing VO and Nivolumab to Doctor's Choice in Advanced Melanoma That Has Progressed After Anti-PD-1 & Anti-CTLA-4 Treatments

Sponsor: Replimune Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06264180

Provider View

This clinical trial is testing a new treatment combination of VO and nivolumab against the treatment chosen by doctors for patients with advanced melanoma that has not responded to previous therapies.

Patient Parameters

Program Overview

This study is looking at whether a combination of the drugs VO and nivolumab can be more effective than the treatment chosen by doctors for patients with advanced melanoma. The patients in this study have melanoma that cannot be removed by surgery and has progressed after receiving treatments that target PD-1 and CTLA-4 proteins, or are not suitable for CTLA-4 treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 12 years or older.
  • Have advanced melanoma that cannot be surgically removed or has spread.
  • The cancer must have worsened after treatment with both anti-PD-1 and anti-CTLA-4 drugs.
    • Must have been on anti-PD-1 treatment for at least 8 weeks.
    • Patients not suitable for anti-CTLA-4 treatment are eligible.
  • Must know BRAF V600 mutation status and have had prior BRAF-targeted therapy if applicable.
  • Have at least one tumor that can be measured and injected, at least 1 cm in size.
  • Have good blood, liver, and kidney function.
  • Blood clotting times must be within normal limits.
  • Have a performance status score of 0 to 1 for adults or a score of 80 or higher for ages 12 to 17.
  • Life expectancy of at least 3 months.
  • Must agree to use effective birth control during and for 6 months after treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have primary mucosal or uveal melanoma.
  • Have had more than 2 treatments for advanced melanoma.
  • Have active hepatitis or HIV infection.
  • Have active or serious herpes infections.
  • Have had a serious infection requiring treatment within 14 days before starting the study.
  • Have spinal cord compression or risk of it.
  • Have active cancer spread to the brain or spinal fluid.
  • Have high levels of LDH in the blood.
  • Have had major surgery within 2 weeks before starting the study.
  • Have had another active cancer in the past 3 years, except for certain curable cancers.
  • Have significant heart disease.
  • Have had severe side effects from previous immune treatments.
  • Have an autoimmune disease needing treatment.
  • Have had lung inflammation needing steroids.
  • Have had previous oncolytic virus therapy.
  • Need regular antiviral medication for herpes.
  • Have had a live vaccine within 28 days before starting the study.
  • Have had cancer treatments recently.
  • Need high doses of steroids for conditions other than replacement therapy.

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