Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp

NCT07803562 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 814015
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a low dose of dexamethasone can prevent cytokine release syndrome in participants treated with tebentafusp for advanced uveal melanoma. The main questions the study aims to answer are: How many participants get cytokine release syndrome? How severe is the cytokine release syndrome? What other side effects happen due to dexamethasone and/or tebentafusp? Participants will be treated with tebentafusp per standard practices. For this study, participants will receive dexamethasone before infusion of the first 4 doses of tebentafusp. Participants will have visits for checkups and tests at the time they are given the medications and 9 weeks after they started. Other visits will be approximately every 6 months for at least 2 years and can be done in person or remotely (telehealth).

Conditions

Uveal Melanoma, Metastatic

Keywords

Tebentafusp; Dexamethasone; Cytokine release syndrome; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Grade ≥2 cytokine release syndrome

  Proportion of participants with grade ≥2 cytokine release syndrome

  During the first 4 doses of tebentafusp treatment (fourth dose is on day 22)

Study Arms (1)

Prophylactic low-dose dexamethasone

EXPERIMENTAL

Low-dose dexamethasone premedication in patients receiving the first 4 doses of tebentafusp

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Prophylactic low-dose dexamethasone premedication

Also known as: Decadron, Dexasone, Hexadrol, Ozurdex, Dextenza, Baycadron, Dxevo, ZoDex, Deronil

Prophylactic low-dose dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Age ≥18 years.
• Histologically confirmed advanced uveal melanoma.
• HLA-A\*02:01 positive as determined per standard of care before enrollment in the study.
• Planned treatment with tebentafusp as first-line systemic therapy for advanced uveal melanoma per standard of care.
• For participants able to become pregnant: use of highly effective contraception for at least 4 weeks prior to initiation of tebentafusp and agreement to use such a method for duration of tebentafusp treatment until 6 months after the last dose of tebentafusp.
• For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner from trial initiation and for duration of tebentafusp treatment until 6 months after the last dose of tebentafusp.

You may not qualify if:

• Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry.
• Pregnancy or lactation.
• Known severe hypersensitivity reaction to monoclonal antibodies or biologics.

Sponsors & Collaborators

• University of California, San Diego: lead
• Immunocore Ltd: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Neoplasm Metastasis; Cytokine Release Syndrome

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Melanoma; 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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Soo Park, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Park, MD

CONTACT

858-822-5354; cancerCTO@health.ucsd.edu

Skin Research Team

CONTACT

858-822-5354; cancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: Simon two-stage design

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)