Clinical trial · Interventional
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
A Phase I, Open-label, Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in First-line Malignant Melanoma Patients Planned for Treatment With Pembrolizumab
NCT03538314CI-TRIAL-00080049completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| UV1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Treatment
- description
- UV1/GM-CSF
- interventionNames
- Drug: UV1
- Drug: GM-CSF
Primary outcomes (1)
- measure
- Number of patients with treatment-related adverse events
- timeFrame
- Up to week 29
- description
- Frequency and severity of adverse events
Secondary outcomes (2)
- measure
- Tumor response
- timeFrame
- Up to week 52
- description
- RECIST and iRECIST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Stage IIIB, IIIC or IV melanoma 2. Previously untreated and eligible for pembrolizumab treatment (prior treatment with BRAF and MEK inhibitors permitted) 3) Adequate blood, liver and kidney function 4) Consent to undergo tumor biopsies during the study Exclusion Criteria: 1. Uveal or ocular malignant melanoma 2. History of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed 3. Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior treatment with BRAF and MEK inhibitors permitted. A washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed. 4. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus. 5. Known hypersensitivity to GM-CSF 6. Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose 7. Men who plan to become a father during the study through 4 months after the last dose of study medication 8. Known history of, or any evidence of active, non-infectious pneumonitis 9. History of cardiac disease
References
Publications (0)
Data not yet available
No reference posted for this study.