Spots Global Cancer Trial Database for Pembrolizumab Effects on NK Cell Exhaustion in Melanoma (Merck NK-IIT)
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Trial Identification
Brief Title: Pembrolizumab Effects on NK Cell Exhaustion in Melanoma (Merck NK-IIT)
Official Title: A Phase II Study Assessing the Effect of Pembrolizumab Induced Changes to the NK Cell Exhaustion Phenotype on the Efficacy of PD-1 Targeted Treatment in Patients With Unresectable Stage III or Stage IV Melanoma
Study ID: NCT03241927
Conditions
Interventions
Study Description
Brief Summary: Melanoma is an immune-modulated malignancy and immune checkpoint modulators which inhibit PD-1 function (pembrolizumab, nivolumab) have demonstrated clinical efficacy as treatment for patients with stage IV melanoma. Pembrolizumab across a range of doses in phase I investigation has demonstrated clinical efficacy with RR approximately 27%. By better understanding how NK cell function and exhaustion interplays with PD1 function and activity, potentially more efficacious combination therapies can be developed. The pharmacodynamic studies to be performed as part of this trial will provide such information.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Contact Details
Name: Nina Bhardwaj, MD, PhD
Affiliation: Icahn School of Medicine at Mount Sinai
Role: PRINCIPAL_INVESTIGATOR
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