Trial studying safety and effects for Metastatic Uveal Melanoma
Official title A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT06581406
What this study is testing
What is RP2?
RP2 is an investigational biological medicine being studied as a potential treatment for metastatic uveal melanoma. It is designed to use a genetically modified virus to break down tumor cells and stimulate the immune system.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to compare the clinical benefits of the two drug combinations in patients with metastatic uveal melanoma who have not yet received immune checkpoint inhibitor therapy.
- Who it's for
- Adult patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitors.
- What's involved
- Participants will receive either RP2 with nivolumab or nivolumab with ipilimumab, along with scheduled clinic visits and medical tests to monitor safety and effectiveness.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
- Must be willing to provide tumor biopsy samples.
- LDH ≤ 2 × upper limit of normal (ULN).
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Englewood, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Germantown, Tennessee, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Englewood, Colorado, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.