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NCT04370509 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab With or Without Axitinib for Clear Cell Kidney Cancer in Patients Undergoing Surgery
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04370509: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT04370509 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04370509, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This phase II trial studies how well pembrolizumab with or without standard of care axitinib works in treating patients with clear cell kidney cancer that has spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic) who are undergoing surgery. Pembrolizumab is an antibody that is designed to bind to and block the activity of PD-1, a molecule in the body that may be responsible for inhibiting the body's immune response against cancer cells. Axitinib is a type of drug known as a tyrosine kinase inhibitor. Tyrosine kinase inhibitors work by blocking enzymes called tyrosine kinases. These enzymes may be too active or found at high levels in some types of cancer cells and blocking them may help keep cancer cells from growing. Giving pembrolizumab with or without axitinib may work better in controlling the cancer and decrease the likelihood of it coming back following surgery in patients with kidney cancer compared to usual treatment (surgery followed by chemotherapy and/or radiation therapy).
Primary Outcome
TIICs will be analyzed in pre- and post-pembrolizumab-based treatment tumor specimens. The proportion of participants with a \>=2-fold increase (from pre- to post-treatment) in the number of TIICs will be calculated.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Axitinib (VEGF-TKI)
- PROCEDURE Cytoreductive Nephrectomy (CN)
- PROCEDURE Metastasectomy (MET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 2 |
Why NCT04370509 stopped before completion
NCT04370509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04370509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04370509 about?
NCT04370509 is a clinical study titled "Pembrolizumab With or Without Axitinib for Clear Cell Kidney Cancer in Patients Undergoing Surgery". This phase II trial studies how well pembrolizumab with or without standard of care axitinib works in treating patients with clear cell kidney cancer that has spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic) who are undergoing surgery. Pembrolizumab...
What is the current status of trial NCT04370509?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2021-02-09. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT04370509?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Axitinib (VEGF-TKI) (DRUG), Cytoreductive Nephrectomy (CN) (PROCEDURE), Metastasectomy (MET) (PROCEDURE).
Who is sponsoring clinical trial NCT04370509?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04370509's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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