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

NCT04960891 | Unknown

• 1 other identifier: IMCgp100-402 EA
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Expanded Access Program aims to:

1. 1.Provide access to tebentafusp for mUM patients.
2. 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. 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.

Conditions

Uveal Melanoma

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

Interventions

Tebentafusp DRUG

Concentrate solution for intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunocore Ltd: lead
• Clinigen, Inc.: collaborator

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

tebentafusp

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Medical Information

CONTACT

1-844-IMMUNO-1; medical.information@immunocore.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 14, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01