Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
Approximately 50 ABA+ subjects with resectable, Stage III (IIIB, IIIC, or IIID) melanoma will be included in the study and randomized in a 3:2 ratio to neoadjuvant treatment with Imprime PGG plus pembrolizumab vs. pembrolizumab monotherapy. A baseline, reference biopsy and a PET/CT scan will be obtained prior to commencing 3 cycles (9 weeks) of neoadjuvant treatment with either regimen. During Week 5, subjects will provide another biopsy to assess treatment effects on the tumor and its microenvironment. At the completion of neoadjuvant treatment and before surgery, subjects will undergo another PET/CT scan to assess radiological and metabolic response compared to baseline.
Epistemonikos ID: 0e0028f151a4d44853987f0c4522d789ab12d270
First added on: May 09, 2024