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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

Status
Active
Cancer Type
Eye Cancer
Melanoma
Unknown Primary
Trial Phase
Phase II
Phase III
Eligibility
0 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06581406
Protocol IDs
RP2-202 (primary)
NCI-2024-07892
Study Sponsor
Replimune Inc.

Summary

The purpose of this study is to measure the clinical benefits of the combination of RP2
and nivolumab as compared with the combination of nivolumab and ipilimumab in patients
with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor
therapy.

Eligibility

  1. Patients who are 18 years of age or older at the time of signed informed consent.
  2. Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
  3. 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.
  4. Must be willing to provide tumor biopsy samples.
  5. LDH = 2 × upper limit of normal (ULN).
  6. Has adequate hematologic, hepatic and renal function
  7. 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.
  8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  9. Life expectancy of > 6 months as estimated by the Investigator. Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.