Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.

Official Title

Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination With CMP-001 in Patients With Operable Melanoma: Efficacy and Biomarker Study

Details

Keywords

Clinical Stage III Cutaneous Melanoma AJCC v8, Melanoma of Unknown Primary, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Recurrent Cutaneous Melanoma, Melanoma, Cutaneous Malignant Melanoma, Skin Neoplasms, Pembrolizumab, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Surgical Procedure, VLP-encapsulated TLR9 Agonist CMP-001, CMP-001, pembrolizumab

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04708418
Phase
Phase 2 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated