Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ultimovacs ASA
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
