UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
- Conditions
- Malignant Melanoma
- Registration Number
- NCT03538314
- Lead Sponsor
- Ultimovacs ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Key Inclusion Criteria:<br><br> 1. Stage IIIB, IIIC or IV melanoma<br><br> 2. Previously untreated and eligible for pembrolizumab treatment (prior treatment with<br> BRAF and MEK inhibitors permitted) 3) Adequate blood, liver and kidney function 4)<br> Consent to undergo tumor biopsies during the study<br><br>Exclusion Criteria:<br><br> 1. Uveal or ocular malignant melanoma<br><br> 2. History of hematologic or primary solid tumor malignancy with the exception of<br> patients in remission for at least 5 years, as judged by the investigator are<br> allowed<br><br> 3. Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior<br> treatment with BRAF and MEK inhibitors permitted. A washout period of at least<br> 3-half-lives (median terminal half-life) prior to the first dose of trial treatment<br> must have elapsed.<br><br> 4. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or<br> oncolytic virus.<br><br> 5. Known hypersensitivity to GM-CSF<br><br> 6. Women who are breastfeeding, pregnant or expect to be pregnant during the study<br> through 6 months after the last dose<br><br> 7. Men who plan to become a father during the study through 4 months after the last<br> dose of study medication<br><br> 8. Known history of, or any evidence of active, non-infectious pneumonitis<br><br> 9. History of cardiac disease
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients with treatment-related adverse events
- Secondary Outcome Measures
Name Time Method Tumor response;The length of time from the start of treatment that patients are still alive.