New hope for rare eye cancer: experimental combo aims to shrink tumors and extend life
NCT ID NCT06581406
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new drug called RP2, given with nivolumab, works better than the current standard combination (ipilimumab plus nivolumab) for people with metastatic uveal melanoma, a rare eye cancer that has spread. About 280 adults who have not had prior immunotherapy will receive either the new or standard treatment. The goal is to see if the new combo helps people live longer or keeps the cancer from growing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * 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. * LDH ≤ 2 × upper limit of normal (ULN). * Has adequate hematologic, hepatic and renal function * Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \[INR\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Life expectancy of \> 6 months as estimated by the Investigator. Key Exclusion Criteria: * Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma. * Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection. * Current active significant herpetic infections or prior complications of HSV-1 infection. * Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis. * Major surgery ≤ 2 weeks prior to the first dose of study intervention. * Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy. * Active, known, or suspected autoimmune disease requiring systemic treatment. * Prior treatment with an oncolytic virus. * Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir). * Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose. * Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose. * Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment. Additional inclusion/ exclusion criteria are outlined in the study protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
33 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Emory Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Georgetown University Medical Center
RECRUITINGWashington D.C., District of Columbia, 20007, United States
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HonorHealth Research Insisute
RECRUITINGScottsdale, Arizona, 85258, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic - Jacksonville FL
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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Melanoma Institute Australia
RECRUITINGWollstonecraft, New South Wales, 2065, Australia
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Northwestern Memorial Hospital
RECRUITINGChicago, Illinois, 60611, United States
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, Victoria, 3000, Australia
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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Stanford Cancer Institute
RECRUITINGPalo Alto, California, 94304, United States
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Sylvester Comprehensive Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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The Angeles Clinic and Research Institute
RECRUITINGLos Angeles, California, 90025, United States
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The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITINGLiverpool, Merseyside, L7 8YA, United Kingdom
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The Melanoma & Skin Cancer Institute
RECRUITINGEnglewood, Colorado, 80113, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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The Royal Marsden NHS Foundation Trust
RECRUITINGLondon, SW3 6JJ, United Kingdom
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The University Of Texas Md Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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The West Clinic, PLLC dba West Cancer Center
RECRUITINGGermantown, Tennessee, 38138, United States
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Thomas Jefferson University
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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UC San Diego Moores Cancer Center
RECRUITINGLa Jolla, California, 92037, United States
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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University Of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
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University of California Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
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University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
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University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
RECRUITINGAurora, Colorado, 80045, United States
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University of Iowa
RECRUITINGIowa City, Iowa, 52242, United States
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University of Tennessee Medical Center
RECRUITINGKnoxville, Tennessee, 37920, United States
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Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)
RECRUITINGNashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo tame a rare eye cancer that has spread?
- Can a new drug shrink Hard-to-Treat eye cancer?
- Double immunotherapy plus liver blockade targets eye cancer that spreads
- First-in-Class cancer drug targets Hard-to-Treat tumors
- Engineered immune cells take on Hard-to-Treat melanoma
- Immune cell therapy shows promise against rare eye cancer