At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Unresectable or metastatic melanoma with progressive, persistent, or recurrent disease on or after standard of care
- ✓Cohort A: Anti-PD-1/PD-L1 naïve, candidate for nivolumab monotherapy
- ✓Cohort B: Progressive disease on anti-PD-1 monotherapy without serious/life-threatening toxicity
- ✕Not recovered to grade 0–1 from prior chemotherapy, radiotherapy, or biotherapy adverse events
- ✕Less than 4 weeks from major surgery
- ✕History of life-threatening or severe immune-related adverse events on prior immunotherapy with ongoing risk
- ✕Requires systemic antineoplastic therapy concurrently
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Nivolumab and PD-L1/IDO peptide vaccine for Metastatic Melanoma. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
Combination therapy is becoming more and more general in the treatment of oncological diseases. In this clinical trial combination the standard immunotherapeutic treatment; the programmed death 1 (PD-1) regulatory antibody Nivolumab and a peptide vaccine consisting of programmed death ligand 1 (PD-L1) and Indoleamine 2,3-dioxygenase (IDO) peptides will be tested in patients with metastatic melanoma. Patients will be treated with Nivolumab every second week as long as there is clinical benefit. The PD-L1/IDO peptide vaccine is given from start of Nivolumab and every second week for the first 6 vaccines and thereafter every fourth week up to 1 year.
Study Details
Timeline
Interventions
Nivolumab 3 mg/kg is administered biweekly as long as there is clinical benefit.
The vaccine is administered biweekly for a total of 6 times, then every fourth week up to 47 weeks, whereupon no additional vaccinations will be given. A total of 15 vaccines will be administered. A vaccine consists of 100 μg PD-L1 long1 peptide, 100 μg IDO long peptide and 500 μl Montande as adjuvant.