RecruitingMelanoma, Cutaneous Malignant

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Eligible age

18+ yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this study

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/

Sponsor: Immatics US, Inc.

You may qualify if…

✓ Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) 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)

You may not qualify if…

✕ Primary mucosal or uveal melanoma
✕ History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
✕ Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
✕ History of cardiac conditions as per protocol
✕ Prior allogenic stem cell transplantation or solid organ transplantation
✕ Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
✕ History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
✕ History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs