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Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma

ConditionsMetastatic Uveal MelanomaMetastatic Uveal Melanoma in the Liver
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review

Serum bilirubin <2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN)

Mapping angiogram procedure shows radioembolization is feasible and safe to perform

Human leukocyte antigen-A*02:01(HLA A⁕ 02:01) positive

Disqualifiers

Patient with any tumor size > 8 cm

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 (ALT) > 3 × ULN

Aspartate aminotransferase (AST) > 3 × ULN

Trial design

Design model

Single group

Treatments tested in this trial

  • Tebentafusp

    Drug

    Tebentafusp will be administered intravenously to participants at or within 28 days of their first Y-90 TARE procedure. This 28-day period includes the 14- to 28-day Y-90 TARE Recovery Period. For administrative purposes, one cycle of tebentafusp treatment is 28 days in length. Tebentafusp will be administered on a dose escalation schedule for Cycle 1 starting at 20 mcg on Day 1, increasing to 30 mcg on Day 8, and a final dose of 68 mcg on Day 15, which will be administered once per week until unacceptable toxicity develops, disease progression, or withdrawal of consent, whichever occurs first.

  • TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization

    Radiation

    Participants will undergo radiographic and 99mTC-labeled macroaggregated albumin (99mTc-MAA) assessment for suitability prior to Y-90 absorbed glass microsphere treatment per institutional procedures. Y-90 trans-arterial radioembolization (TARE) is a standard of care treatment for intrahepatic metastases of uveal melanoma as indicated in the National Comprehensive Cancer Network (NCCN) consensus guidelines (NCCN Guidelines®, 2023). Y-90 absorbed glass microspheres will be administered at least one time prior to initiating Tebentafusp treatment. After the Y90-TARE procedure, participants will have a 14- to 28-day Y-90 TARE Recovery Period.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Tebentafusp in combination with Radioembolization GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Progression-free survival (PFS) will be defined as the elapsed time in months from the first date of study treatment until documented disease progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever is earlier. For participants who remain alive without progression, follow-up time will be censored at the date of last disease assessment.

Time frame
Up to 24 months
2

Number of Participants Experiencing Treatment-Related Adverse Events

The number of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

Time frame
Up to 24 months

Secondary outcomes

1

Disease control rate (DCR) measured by proportion of patients

Disease control rate (DCR) is the proportion of patients whose best response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is complete response (CR), partial response (PR), or stable disease (SD) confirmed with new assessments by CT or MRI imaging prior to starting new anticancer therapies. Response recorded after non-protocol anticancer therapy will not be counted.

Time frame
Up to 24 months
2

Overall response rate (ORR)

Overall response rate (ORR) is the proportion of patients whose best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is complete response (CR) or partial response (PR). Response recorded after non-protocol anticancer therapy will not be counted.

Time frame
Up to 2 years
3

Duration of response (DOR)

The duration of overall response (DOR) is measured from the time in months measurement criteria are met for complete response (CR) or partial response (PR) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). For participants without progression, follow-up time will be censored at the date of last disease assessment (as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1).

Time frame
Up to 24 months
4

Overall survival (OS)

Overall survival (OS) is defined as the elapsed time in years from date of first study treatment until death from any cause. Participants without documented death will be censored at the last date known to be alive.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Immunocore Ltd

Collaborator

Source ClinicalTrials.gov
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