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NCT04393350 · ClinicalTrials.gov registry record · Phase 2
Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
A Phase 2 study of Kidney Cancer and Stage IV Renal Cell Cancer AJCC v8, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04393350: Active Phase 2 study of Kidney Cancer and Stage IV Renal Cell Cancer AJCC v8, sponsored by Emory University.
NCT04393350 is a Phase 2 study of Kidney Cancer and Stage IV Renal Cell Cancer AJCC v8 that is active but no longer recruiting, run by Emory University. The registered enrollment target is 18 participants, below the 880-participant average among 60 other Kidney Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04393350, a Phase 2 study of Kidney Cancer and Stage IV Renal Cell Cancer AJCC v8, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well lenvatinib and pembrolizumab before surgery work in treating patients with kidney cancer that has spread from its original site of growth to nearby tissues or lymph nodes but has not spread to other places in the body (non-metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving lenvatinib and pembrolizumab before surgery may kill more tumor cells.
Primary Outcome
Will assess the proportion of patients with a reduction in overall tumor burden from baseline after 12 weeks of treatment with neoadjuvant lenvatinib and pembrolizumab.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Lenvatinib
- DRUG Lenvatinib Mesylate
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2026-01-16 |
| Phase | Phase 2 |
What the registry record for NCT04393350 still lists
NCT04393350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 880-participant average among 60 other Kidney Cancer trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Kidney Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04393350 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04393350 about?
NCT04393350 is a clinical study titled "Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma". This phase II trial studies how well lenvatinib and pembrolizumab before surgery work in treating patients with kidney cancer that has spread from its original site of growth to nearby tissues or lymph nodes but has not spread to other places in the body (non-metastatic). Lenvatinib may stop the gro...
What is the current status of trial NCT04393350?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-06-22. Estimated completion is 2026-01-16.
What conditions does trial NCT04393350 study?
This clinical trial studies the following conditions: Kidney Cancer, Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8.
What interventions are being tested in trial NCT04393350?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Lenvatinib (DRUG), Lenvatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT04393350?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04393350 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04393350's enrollment target sits among peer trials
18 51st of 60 higher than 9 of 60 other Kidney Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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