Brief Title
A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
Official Title
A Cohort IND Expanded Access Program (EAP) for Tebentafusp for Treatment of HLA-A*02:01 Positive Patients With Metastatic Uveal Melanoma
Brief Summary
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.
Study Type
Expanded Access
Condition
Uveal Melanoma
Intervention
Tebentafusp
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Eligibility Criteria
Inclusion Criteria:
Age
1. Male or female patients age ≥ 18 years of age at the time of first dose
Type of Participant and Disease Characteristics
2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients
3. HLA-A*02:01 positive
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Informed Consent
5. Ability to provide and understand informed consent prior to procedures [if required]
Contraception
6. 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.
1. Pregnant or lactating women are prohibited from enrolling on this program.
2. 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
1. 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:
1. Treated CNS lesions must be radiographically stable for ≥ 2 weeks after
intervention (surgery and/or radiation).
2. Participants must be neurologically stable off systemic corticosteroids for at
least 2 weeks prior to first planned administration of tebentafusp.
2. Receipt of anticancer therapy for the disease under study within the following times
prior to the first planned dose of program intervention:
1. Cellular therapies (e.g., T-cell therapies): 90 days.
2. Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)- targeted immunotherapies
(e.g., ipilimumab): 28 days
3. All other immunotherapies, including PD-(L)1-targeted immunotherapies (e.g.,
atezolizumab, pembrolizumab): 21 days
4. All other systemic therapies: 14 days
5. 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
3. 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:
1. Treatment for well-controlled and asymptomatic adrenal insufficiency is
permitted, but replacement dosing is limited to prednisone ≤ 12 mg daily or the
equivalent.
2. Local steroid therapies (e.g., optic, ophthalmic, intra- articular, or inhaled
medications) are acceptable.
3. Premedication for allergy to contrast reagent.
4. Steroids for management of CNS metastases > 2 weeks prior to the planned first
dose of program intervention.
4. 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.
5. Chronic viral infections as indicated below. NOTE: Testing for hepatitis C virus (HCV)
status prior to enrollment is not necessary unless clinically indicated.
1. Known history of human immunodeficiency virus (HIV) infection.
2. 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.
3. Known HCV infection, unless the participant has received curative treatment and
viral load was confirmed as undetectable during Screening.
Diagnostic Assessments
6. 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.
1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 30
mL/minute
2. 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
3. Alanine aminotransferase > 5 × ULN
4. Aspartate aminotransferase > 5 × ULN
5. Platelet count < 50 × 109/L
6. Hemoglobin < 8 g/dL
7. Clinically significant cardiac disease or impaired cardiac function, including any of
the following:
1. Congestive heart failure (New York Heart Association Class ≥ 3)
2. Uncontrolled hypertension defined as systolic blood pressure [BP] > 160 mmHg or
diastolic BP > 110 mmHg with the following requirements:
1. 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.
2. Eligibility is based on the average of at least 2 assessments taken at least 1
hour apart.
3. Acute myocardial infarction or unstable angina pectoris < 6 months prior to the
planned first dose of program intervention
Gender
All
Ages
18 Years - N/A
Contacts
, 1-844-IMMUNO-1, [email protected]
Administrative Informations
NCT ID
NCT04960891
Organization ID
IMCgp100-402 EA
Responsible Party
Sponsor
Study Sponsor
Immunocore Ltd
Collaborators
Clinigen, Inc.
Study Sponsor
, ,
Verification Date
January 2022