Trials / Terminated
TerminatedNCT02212730
A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)
A Clinical Trial to Evaluate the Effect of Neoadjuvant MK-3475 (Pembrolizumab) Therapy on Intratumoral Immune Infiltrates in Renal Cell Cancer (RCC) Patients Undergoing Surgical Resection
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with RCC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab Pre-Resection | 200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles |
| PROCEDURE | Surgical Resection | Standard of care surgical resection of RCC tumor |
| DRUG | Pembrolizumab Post-Resection | 200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles |
Timeline
- Start date
- 2014-12-03
- Primary completion
- 2019-07-05
- Completion
- 2019-07-05
- First posted
- 2014-08-08
- Last updated
- 2020-07-16
- Results posted
- 2020-07-16
Source: ClinicalTrials.gov record NCT02212730. Inclusion in this directory is not an endorsement.