Trials / Terminated
TerminatedNCT03241927
Pembrolizumab Effects on NK Cell Exhaustion in Melanoma (Merck NK-IIT)
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Nina Bhardwaj · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | Day 1 of each 3 week cycle |
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2018-06-06
- Completion
- 2018-06-06
- First posted
- 2017-08-08
- Last updated
- 2020-11-23
- Results posted
- 2020-11-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03241927. Inclusion in this directory is not an endorsement.