Health TrialsbyHealthPanel

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

ConditionMelanoma, Cutaneous Malignant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmatics US, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMA203

    Biological/Vaccine

    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

    Biological/Vaccine

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • lifileucel

    Biological/Vaccine

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • nivolumab

    Biological/Vaccine

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • pembrolizumab

    Biological/Vaccine

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • ipilimumab

    Biological/Vaccine

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • Dacarbazine

    Drug

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • temozolomide

    Drug

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • paclitaxel

    Drug

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • paclitaxel plus carboplatin

    Drug

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

  • Albumin-Bound Paclitaxel

    Drug

    in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 1 intervention
Group B: Control arm- investigator's choiceActive comparator 10 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival assessed by BICR

progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1

Time frame
up to 5 years post first treatment of last patient

Secondary outcomes

1

Overall survival (OS)

conducted onsite or can be performed by phone

Time frame
up to 5 years post first treatment of last patient
2

Objective response rate (ORR)

complete responses (CR) and partial response (PR) based on best overall response (BOR), locally and centrally (by blinded independent central review) assessed using RECIST 1.1

Time frame
up to 5 years post first treatment of last patient
3

Progression-free survival

Progression-free survival locally assessed using RECIST 1.1

Time frame
up to 5 years post first treatment of last patient
4

Treatment-emergent adverse events (TEAEs)

To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)

Time frame
until 85 days after cell therapy treatment or 30 days after last treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immatics US, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now