Enrolling
CMP-001-010: A Multicenter, Open-label, Phase 2 Study of Intratumoral Vidutolimod (CMP-001) in Combination With Intravenous Nivolumab in Subjects With Refractory Unresectable or Metastatic Melanoma
CMP-001-011: A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral Vidutolimod (CMP-001) in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma

Melanoma

Checkmate Pharmaceuticals is conducting studies of vidutolimod (CMP-001) in combination with nivolumab for the treatment of advanced, PD-1 refractory melanoma and first-line (PD-1-naïve) melanoma. Melanoma is a serious form of skin cancer that arises from a particular skin cell type called a melanocyte. This form of skin cancer is particularly dangerous because of its ability to rapidly spread to other organs if not surgically removed at an early stage, as well as its low response rates and limited durability of response when treated with commonly used chemotherapeutics. In 2020, melanoma of the skin is estimated to be the fifth most diagnosed cancer, and accounts for approximately 1% of all skin cancers in the U.S. According to the American Cancer Society, there will be an estimated 100,350 new diagnoses and approximately 6,850 patients will die as a result of melanoma in the United States in 2020.

Clinical Trial Overview

CMP-001-010

CMP-001-010 is a Phase 2 clinical trial of vidutolimod intratumoral (IT) and nivolumab intravenous (IV) administered to participants with unresectable or metastatic melanoma whose cancer has progressed during or after treatment with Opdivo (nivolumab) or Keytruda (pembrolizumab).

The study is designed to determine confirmed objective response rate (ORR) for treatment with vidutolimod in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.

To learn more about this clinical trial or to view a list of active trial site locations, please visit:

CMP-001-011

CMP-001-011 is a Phase 2/3 clinical trial of vidutolimod intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma who have not been previously treated with immunotherapy.

The study is divided into two phases: Phase 2 and Phase 3.

The Phase 2 study is designed to determine confirmed objective response rate (ORR) for treatment with first-line vidutolimod in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.

The Phase 3 study is designed to evaluate progression-free survival (PFS) for subjects receiving first-line vidutolimod in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma.

To learn more about this clinical trial or to view a list of active trial site locations, please visit:

Vidutolimod is an investigational immunotherapy being evaluated in clinical studies and has not been approved by the FDA or any other agency. Clinical trials are designed to evaluate the safety and efficacy of investigational therapies. Please consult your doctor about your eligibility and the benefits and risks of participating in our trials.

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