RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Metastatic Uveal Melanoma

What is the Purpose of this Study?

This study focuses on immune checkpoint inhibitor-naive adults with inoperable metastatic uveal melanoma (a type of aggressive eye cancer that has not been treated with immune checkpoint inhibitor therapies). The purpose of the study is to evaluate the effectiveness and safety of an investigational drug called RP2 in combination with nivolumab, versus ipilimumab in combination with nivolumab. Nivolumab and ipilimumab are drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat several types of cancers, but the combination of nivolumab and RP2 is considered experimental. Nivolumab, ipilimumab, and RP2 are part of a class of drugs often referred to as immunotherapy. RP2 is a herpes simplex virus that has been changed in the laboratory to grow and destroy cancer cells and activate the immune system to attack cancer cells. Study procedures include a screening period (medical history, tumor biopsy, blood, urine and saliva collection, physical exam, MRI/CT scan, ECG); treatment period in which participants will be assigned to receive either nivolumab and RP2 (experimental treatment) or nivolumab and ipilimumab; and follow-up.


Eligibility

  • * Patients who are 18 years of age or older at the time of signed informed consent.
  • * Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
  • * Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \[LN\]) that is amenable to serial RP2 injections.
  • * Must be willing to provide tumor biopsy samples.
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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma

Study Details
Disease Type/Condition

Eye and Orbit, Liver, Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Cathie T Chung, Justin Moyers, Kristopher Wentzel, Navid Hafez, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

II/III

IRB Number

STUDY00003812

ClinicalTrials.gov ID

NCT06581406

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Eye and Orbit, Liver, Melanoma

Principal Investigator

Mehmi, Inderjit

Age Group

Adult

Phase

II/III

IRB Number

RP2-202

ClinicalTrials.gov ID

NCT06581406

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org