A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
ConditionUveal Melanoma
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorImmunocore Ltd
About this trial
This Expanded Access Program aims to:
1. Provide access to tebentafusp for mUM patients. 2. Provide access to tebentafusp for patients, who were on the control arm of the randomized controlled Phase II trial (IMCgp100-202) and were unable to crossover during the specified window. 3. Ensure that patients, who are benefiting from tebentafusp treatment while participating in an ongoing Immunocore sponsored clinical study (e.g., IMCgp100-102 or IMCgp100-201), may continue tebentafusp treatment on this Programme once the ongoing trial has met all of its key primary and secondary objectives.
Eligibility criteria
Qualifiers
Male or female patients age ≥ 18 years of age at the time of first dose
Histologically or cytologically confirmed metastatic UM or unresectable UM patients
HLA-A*02:01 positive
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Disqualifiers
Treated CNS lesions must be radiographically stable for ≥ 2 weeks after intervention (surgery and/or radiation).
Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to first planned administration of tebentafusp.
Cellular therapies (e.g., T-cell therapies): 90 days.
Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)- targeted immunotherapies (e.g., ipilimumab): 28 days
Trial design
Treatments tested in this trial
- Tebentafusp
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Immunocore Ltd
Lead sponsor
Clinigen, Inc.
Collaborator
Source ClinicalTrials.gov