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NCT05969496 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
A Phase 2 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 3
- Study locations
NCT05969496: Recruiting Phase 2 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by University of Colorado, Denver.
NCT05969496 is a Phase 2 study of Renal Cell Carcinoma and Kidney Cancer that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 17 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05969496, a Phase 2 study of Renal Cell Carcinoma and Kidney Cancer, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.
Primary Outcome
* Patients will get baseline imaging with an MRI of the abdomen to evaluate the level of the IVC TT based on the Mayo Classification. Patients will get an end of treatment MRI at 12 weeks to evaluate the efficacy of neoadjuvant therapy with Pembrolizumab and Axitinib. The Mayo classification is described as below: * Level 0: thrombus limited to the renal vein * Level 1: into IVC \<2cm from renal vein ostium level * Level 2: IVC extension \>2cm from renal vein ostium and below hepatic vein * Leve
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Axitinib
Study Locations (3)
Colorado
- University of Colorado Cancer Center - Aurora
- Hilands Ranch Hospital - Highlands Ranch
- Lone Tree Medical Center - Lone Tree
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2029-11 |
| Phase | Phase 2 |
What NCT05969496 shows while recruiting
NCT05969496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05969496 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05969496 about?
NCT05969496 is a clinical study titled "Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus". The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, ...
What is the current status of trial NCT05969496?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2023-12-04. Estimated completion is 2029-11.
What conditions does trial NCT05969496 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Kidney Cancer, Renal Cancer, Inferior Vena Cava Thrombosis.
What interventions are being tested in trial NCT05969496?
The interventions under investigation include: Pembrolizumab (DRUG), Axitinib (DRUG).
Who is sponsoring clinical trial NCT05969496?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05969496 being conducted?
This trial has 3 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05969496's enrollment target sits among peer trials
17 115th of 121 higher than 7 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma 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.
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