A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease

• HLA-A\*02:01 positive

• Adequate selected organ function per protocol

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma

• Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient

• Life expectancy more than 6 months

• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

• Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)

• Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)

• The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.

Locations
United States
Arizona
Honor Health Research Institute
RECRUITING
Scottsdale
California
City of Hope National Medical Center
RECRUITING
Duarte
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
UCLA Hematology/Oncology
RECRUITING
Los Angeles
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
Stanford Cancer Center
RECRUITING
Stanford
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
University of Miami - Sylvester Comprehensive Cancer Cente
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
University of Chicago Medical Center
ACTIVE_NOT_RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
ACTIVE_NOT_RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
University of MD Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
North Carolina
UNC Hospitals, The University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Atlantic Health System/Morristown Medical Center
RECRUITING
Morristown
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic, Taussig Cancer Institute
RECRUITING
Cleveland
Ohio State University
RECRUITING
Columbus
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Thomas Jeffersion University, Sidney Kimmel Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
University of Pennsylvania, Abramson Cancer Center
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Baylor University
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Germany
Charite Universitaetsmedizin Berlin KöR
RECRUITING
Berlin
Universitaetsklinikum Bonn AöR
ACTIVE_NOT_RECRUITING
Bonn
University Hospital Cologne AöR
ACTIVE_NOT_RECRUITING
Cologne
Technische Universitaet Dresden
RECRUITING
Dresden
Universitaetsklinikum Erlangen AöR
RECRUITING
Erlangen
Universitaetsklinikum Essen AöR
RECRUITING
Essen
Goethe University Frankfurt
RECRUITING
Frankfurt Am Main
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg AöR
RECRUITING
Heidelberg
Universitaet Leipzig
RECRUITING
Leipzig
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
RECRUITING
Mainz
Contact Information
Primary
Immatics US, Inc.
ctgovinquiries@immatics.com
+1 346 204-5400
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2031-10
Participants
Target number of participants: 360
Treatments
Experimental: Experimental arm
Non-myeloablative chemotherapy for lymphodepletion (LD) over 4 days using fludarabine (FLU) and cyclophosphamide (CY), 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
Active_comparator: Control arm- investigator's choice
Investigator's choice of treatment approved by the respective Competent Authority (nivolumab plus relatlimab \[Opdualag®\], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy \[e.g., dacarbazine, temozolomide, paclitaxel, alb-bound paclitaxel, or paclitaxel plus carboplatin\]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC), optional bridging therapy.
Related Therapeutic Areas
Sponsors
Leads: Immatics US, Inc.

This content was sourced from clinicaltrials.gov

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