Informations générales (source: ClinicalTrials.gov)
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301
Interventional
Phase 3
Immunocore Ltd (Voir sur ClinicalTrials)
juin 2024
octobre 2027
29 août 2025
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab
compared to standard nivolumab regimens in HLA-A*02:01-positive participants with
previously untreated advanced melanoma.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Ambroise Paré | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez - 59037 - Lille - France | Pr Laurent Mortier | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle - 76031 - Rouen - France | Orlane DEBOVES | Contact (sur clinicalTrials) | |||
| CHU de Dijon Bourgogne - Hôpital François Mitterrand - Dijon - France | Meryem DEBBABI | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - 13385 - Marseille - Cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital Robert Debre - 26000 - Valence - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud - 69310 - Pierre-Benite - France | Contact (sur clinicalTrials) | ||||
| Hospital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse - 31059 - Toulouse - Cedex - France | Contact (sur clinicalTrials) | ||||
| UNICANCER-Centre Francois Baclesse (CFB) - 14000 - Caen - France | Dr Stefan Andreea, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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