Uveal MelanomaNon ApplicableNCT04960891
A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
A study testing Tebentafusp in people with Uveal Melanoma, run by Immunocore Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Tebentafusp
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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:
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Cohort IND Expanded Access Program (EAP) for Tebentafusp for Treatment of HLA-A*02:01 Positive Patients With Metastatic Uveal Melanoma
This Expanded Access Program aims to:
- Provide access to tebentafusp for mUM patients.
- 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.
- 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.
- Conditions
- Uveal Melanoma
- Being tested
- Tebentafusp
- Keywords
- Melanoma, Uveal Cancer, IMCgp100, Immunotherapy, Tebentafusp, Ocular Melanoma, Eye Melanoma, Uveal Melanoma, Gp100, TCR, Bispecific T cell receptor fusion protein, ImmTAC, Immune mobilizing monoclonal T cell receptor against cancer
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TebentafuspDrug
Concentrate solution for intravenous infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Immunocore Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinigen, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960891
- Sponsor's protocol ID
- IMCgp100-402 EA
- Acronym
- Non Applicable
- Status last verified
- Jan 2022
- First submitted
- 2 Jul 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort IND Expanded Access Program (EAP) for Tebentafusp for Treatment of HLA-A*02:01 Positive Patients With Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT04960891
- Acronym / sponsor ID
- Non Applicable / IMCgp100-402 EA
- Conditions
- Uveal Melanoma
- Keywords
- Melanoma, Uveal Cancer, IMCgp100, Immunotherapy, Tebentafusp, Ocular Melanoma, Eye Melanoma, Uveal Melanoma
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Immunocore LtdIndustry (pharma, biotech, devices)
- Collaborators
- Clinigen, Inc.
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Expanded Access Program aims to:
- Provide access to tebentafusp for mUM patients.
- 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.
- 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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (36 listed)
- 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:
- Receipt of anticancer therapy for the disease under study within the following times prior to the first planned dose of program intervention:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TebentafuspConcentrate solution for intravenous infusion | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tebentafusp in people with Uveal Melanoma, run by Immunocore Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (1-844-IMMUNO-1, medical.information@immunocore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.