IMC-F106C-301

Studieninformationen

Studien-Code

UME-ID-11454

Studien-Akronym

IMC-F106C-301

Studientitel

A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

NCT-Nummer: NCT06112314

Aktueller Studienstatus: Aktiv, rekrutierend

Studie aktiv in den Jahren: 2024,2025,2026

Beteiligte

Institut

Westdeutsches Tumorzentrum
Dermatologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Schadendorf

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Immunocore Limited, UK


Studiendesign

randomisiert, offen, kontrolliert, multizentrisch, international

Einschlusskriterien

- Participants must be HLA-A*02:01-positive

- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma

- Archived or fresh tumor tissue sample that must be confirmed as adequate

- Participants must have measurable disease per RECIST 1.1

- Participant must have BRAF V600 mutation status determined

- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention

Ausschlusskriterien

- Participants with a history of a malignant disease other than those being treated in this study

- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis

- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients

- Participants with clinically significant pulmonary disease or impaired lung function

- Participants with clinically significant cardiac disease or impaired cardiac function

- Participants with active autoimmune disease requiring immunosuppressive treatment

- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results

- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma

- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Studienteilnehmende Mindestalter

Jahr(e)

Indikation

Melanom

Medizinischer Befund

Advanced melanoma