A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp


Study First Submitted Date 2021-07-02
Study First Posted Date 2021-07-14
Last Update Posted Date 2022-01-21
Verification Month Year January 2022
Verification Date 2022-01-31
Last Update Posted Date 2022-01-21


Sequence: 52259284
Name Uveal Melanoma
Downcase Name uveal melanoma

Id Information

Sequence: 40222884
Id Source org_study_id
Id Value IMCgp100-402 EA


Sequence: 52572022
Intervention Type Drug
Name Tebentafusp
Description Concentrate solution for intravenous infusion


Sequence: 79994232 Sequence: 79994233 Sequence: 79994234 Sequence: 79994235 Sequence: 79994236 Sequence: 79994237 Sequence: 79994238 Sequence: 79994239 Sequence: 79994240 Sequence: 79994241 Sequence: 79994242 Sequence: 79994243 Sequence: 79994244
Name Melanoma Name Uveal Cancer Name IMCgp100 Name Immunotherapy Name Tebentafusp Name Ocular Melanoma Name Eye Melanoma Name Uveal Melanoma Name Gp100 Name TCR Name Bispecific T cell receptor fusion protein Name ImmTAC Name Immune mobilizing monoclonal T cell receptor against cancer
Downcase Name melanoma Downcase Name uveal cancer Downcase Name imcgp100 Downcase Name immunotherapy Downcase Name tebentafusp Downcase Name ocular melanoma Downcase Name eye melanoma Downcase Name uveal melanoma Downcase Name gp100 Downcase Name tcr Downcase Name bispecific t cell receptor fusion protein Downcase Name immtac Downcase Name immune mobilizing monoclonal t cell receptor against cancer

Browse Conditions

Sequence: 193823630 Sequence: 193823631 Sequence: 193823632 Sequence: 193823633 Sequence: 193823634 Sequence: 193823635 Sequence: 193823636 Sequence: 193823637 Sequence: 193823638 Sequence: 193823639 Sequence: 193823640 Sequence: 193823641 Sequence: 193823642
Mesh Term Melanoma Mesh Term Uveal Neoplasms Mesh Term Neuroendocrine Tumors Mesh Term Neuroectodermal Tumors Mesh Term Neoplasms, Germ Cell and Embryonal Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Nerve Tissue Mesh Term Nevi and Melanomas Mesh Term Eye Neoplasms Mesh Term Neoplasms by Site Mesh Term Eye Diseases Mesh Term Uveal Diseases
Downcase Mesh Term melanoma Downcase Mesh Term uveal neoplasms Downcase Mesh Term neuroendocrine tumors Downcase Mesh Term neuroectodermal tumors Downcase Mesh Term neoplasms, germ cell and embryonal Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, nerve tissue Downcase Mesh Term nevi and melanomas Downcase Mesh Term eye neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term eye diseases Downcase Mesh Term uveal diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48401708 Sequence: 48401709
Agency Class INDUSTRY Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Immunocore Ltd Name Clinigen, Inc.

Central Contacts

Sequence: 12029424
Contact Type primary
Name Medical Information
Phone 1-844-IMMUNO-1
Email medical.information@immunocore.com
Role Contact


Sequence: 30816682
Gender All
Minimum Age 18 Years
Maximum Age N/A
Criteria Inclusion Criteria: Age Male or female patients age ≥ 18 years of age at the time of first dose Type of Participant and Disease Characteristics 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 Informed Consent Ability to provide and understand informed consent prior to procedures [if required] Contraception 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 trial screening date until 1 week after the final dose of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician. Pregnant or lactating women are prohibited from enrolling on this program. Male participants are not allowed to donate sperm from the time of enrolment until 3 months post- administration of program interventions. Exclusion Criteria: Disease Under Study and Prior Anticancer Therapy Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply: 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. Receipt of anticancer therapy for the disease under study within the following times prior to the first planned dose of program intervention: Cellular therapies (e.g., T-cell therapies): 90 days. Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)- targeted immunotherapies (e.g., ipilimumab): 28 days All other immunotherapies, including PD-(L)1-targeted immunotherapies (e.g., atezolizumab, pembrolizumab): 21 days All other systemic therapies: 14 days Radiotherapy: 14 days (excepting palliative radiotherapy to a limited field [e.g., for a focally painful tumor mass], which may be administered within 14 days provided there are no ongoing related Grade 2 or higher toxicities) Medical Conditions and Concomitant Medications Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions: Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent. Local steroid therapies (e.g., optic, ophthalmic, intra- articular, or inhaled medications) are acceptable. Premedication for allergy to contrast reagent. Steroids for management of CNS metastases > 2 weeks prior to the planned first dose of program intervention. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results. Chronic viral infections as indicated below. NOTE: Testing for hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated. Known history of human immunodeficiency virus (HIV) infection. Known HBV infection, unless on stable anti-viral therapy for > 4 weeks prior to the planned first dose of program intervention and viral load confirmed as undetectable during Screening. Known HCV infection, unless the participant has received curative treatment and viral load was confirmed as undetectable during Screening. Diagnostic Assessments Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 30 mL/minute Total bilirubin > 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN Alanine aminotransferase > 5 × ULN Aspartate aminotransferase > 5 × ULN Platelet count < 50 × 109/L Hemoglobin < 8 g/dL Clinically significant cardiac disease or impaired cardiac function, including any of the following: Congestive heart failure (New York Heart Association Class ≥ 3) Uncontrolled hypertension defined as systolic blood pressure [BP] > 160 mmHg or diastolic BP > 110 mmHg with the following requirements: If initial measurement is elevated, additional assessments should be taken where each assessment is the mean value of 3 measurements taken at least 5 minutes apart. Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart. Acute myocardial infarction or unstable angina pectoris < 6 months prior to the planned first dose of program intervention
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254091043
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Responsible Parties

Sequence: 28929051
Responsible Party Type Sponsor