SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
Condition(s) studied
Investigational drug(s) / intervention(s)
IMA203: one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy
nivolumab plus relatlimab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
lifileucel: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
nivolumab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
pembrolizumab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
ipilimumab: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Dacarbazine: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
temozolomide: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel plus carboplatin: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Albumin-Bound Paclitaxel: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Study summary
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.
For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/
Eligibility
Primary outcome measure(s)
- Progression-free survival assessed by BICR — up to 5 years post first treatment of last patient
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
Trial sites (71)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | Recruiting |
| Honor Health Research Institute | Scottsdale | Arizona | Recruiting |
| City of Hope National Medical Center | Duarte | California | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| UCLA Hematology/Oncology | Los Angeles | California | Recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | Recruiting |
| Stanford Cancer Center | Stanford | California | Recruiting |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| University of Miami - Sylvester Comprehensive Cancer Cente | Miami | Florida | Recruiting |
| AdventHealth, Orlando | Orlando | Florida | Not Yet Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | Not Yet Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| University of MD Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | Recruiting |
| Atlantic Health System/Morristown Medical Center | Morristown | New Jersey | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University of Rochester | Rochester | New York | Recruiting |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| Cleveland Clinic, Taussig Cancer Institute | Cleveland | Ohio | Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | Recruiting |
| Lehigh Valley Topper Cancer Institute | Allentown | Pennsylvania | Recruiting |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Thomas Jeffersion University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| Baylor University | Dallas | Texas | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | Recruiting |
+ 31 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06743126 on ClinicalTrials.gov ↗ ← All trials in France