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New hope for rare eye cancer: experimental combo aims to shrink tumors and extend life

NCT ID NCT06581406

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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.

melanoma Neoplasm Metastasis uveal melanoma

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.

  1. The places running it

    33 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • HonorHealth Research Insisute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Jacksonville FL

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Melanoma Institute Australia

    RECRUITING

    Wollstonecraft, New South Wales, 2065, Australia

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stanford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The Angeles Clinic and Research Institute

    RECRUITING

    Los Angeles, California, 90025, United States

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    RECRUITING

    Liverpool, Merseyside, L7 8YA, United Kingdom

  • The Melanoma & Skin Cancer Institute

    RECRUITING

    Englewood, Colorado, 80113, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The University Of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The West Clinic, PLLC dba West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.