Tebentafusp for Uveal Melanoma

Overseen By Danielle L Bednarz, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Diwakar Davar

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.

Research Team

Diwakar Davar, MD

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

This trial is for adults with untreated metastatic uveal melanoma who are HLA-A*0201 positive and have not had systemic therapy for advanced cancer. They must be willing to undergo a ctDNA test, have a life expectancy over 6 months, and an ECOG status of 0 or 1. Excluded are those with severe allergies to biologics, certain heart conditions, active brain metastases, uncontrolled HIV/HBV/HCV infections, recent major surgery or radiotherapy.

Inclusion Criteria

My blood test shows I am HLA-A*0201 positive.

I haven't had chemotherapy or targeted therapy for my advanced cancer.

My eye melanoma has spread and hasn't been treated yet.

Exclusion Criteria

Pregnant, likely to become pregnant, or lactating women

I do not have uncontrolled HIV, HBV, or HCV.

I have not had radiotherapy in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tebentafusp with an intra-patient escalation regimen starting at 20 mcg, followed by 30 mcg, and then 68 mcg weekly on Day 1 of 12-week cycles

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 5 years

Treatment Details

Interventions

• Tebentafusp

Trial Overview The study tests Tebentafusp in patients with specific genetic makeup (HLA-A*0201) who haven't been treated before for their advanced eye melanoma. It's an open-label phase II trial where all participants receive the drug while also having their tumor DNA monitored.

Participant Groups

Group I: Tebentafusp (IMCgp100) Experimental Treatment 1 Intervention

Dose: 20mcg W1D; 30mcg W2D1; 68mcg W3D1and subsequent doses Frequency: Weekly on D1 of 12-week cycles

Tebentafusp is already approved in United States, European Union for the following indications:

Approved in United States as Kimmtrak for:

• Unresectable or metastatic uveal melanoma in HLA-A*02:01-positive adults

Approved in European Union as Kimmtrak for:

• Unresectable or metastatic uveal melanoma in HLA-A*02:01-positive adults

Who Is Running the Clinical Trial?

Diwakar Davar

Lead Sponsor

Trials

12

Recruited

420+

Immunocore Ltd

Industry Sponsor

Trials

17

Recruited

4,400+