Clinical trial · Interventional
Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp
Low-Dose Dexamethasone Premedication for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp in Advanced Uveal Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma, Metastatic | Uveal Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prophylactic low-dose dexamethasone
- description
- Low-dose dexamethasone premedication in patients receiving the first 4 doses of tebentafusp
- interventionNames
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Grade ≥2 cytokine release syndrome
- timeFrame
- During the first 4 doses of tebentafusp treatment (fourth dose is on day 22)
- description
- Proportion of participants with grade ≥2 cytokine release syndrome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age ≥18 years. 4. Histologically confirmed advanced uveal melanoma. 5. HLA-A\*02:01 positive as determined per standard of care before enrollment in the study. 6. Planned treatment with tebentafusp as first-line systemic therapy for advanced uveal melanoma per standard of care. 7. 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. 8. 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. Exclusion Criteria: 1. Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry. 2. Pregnancy or lactation. 3. Known severe hypersensitivity reaction to monoclonal antibodies or biologics.
References
Publications (0)
Data not yet available