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NCT05665361 · ClinicalTrials.gov registry record · Phase 1
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
A Phase 1 study of Advanced Clear Cell Renal Carcinoma (Ccrcc) and Papillary Renal Cell Carcinoma (Prcc), sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05665361: Recruiting Phase 1 study of Advanced Clear Cell Renal Carcinoma (Ccrcc) and Papillary Renal Cell Carcinoma (Prcc), sponsored by National Cancer Institute (NCI).
NCT05665361 is a Phase 1 study of Advanced Clear Cell Renal Carcinoma (Ccrcc) and Papillary Renal Cell Carcinoma (Prcc) that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665361, a Phase 1 study of Advanced Clear Cell Renal Carcinoma (Ccrcc) and Papillary Renal Cell Carcinoma (Prcc), is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments. Better treatments are needed. Objective: To test a pair of drugs (sasanlimab and palbociclib) in people with kidney cancers. Eligibility: People aged 18 years and older with kidney cancer; specifically, clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC). Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan and a test of their heart function. They may have a biopsy; that is, a sample of tissue will be cut from the tumor. Participants will be treated in 28-day cycles for up to 2 years. Palbociclib is a pill taken by mouth. Participants will take this drug once a day for 21 days during each 28-day treatment cycle. They will write down the dates and times they take these pills in a diary. Sasanlimab is an injection under the skin. Participants will receive this injection on the first day of each treatment cycle. Imaging scans and blood tests will be repeated throughout the treatment. Tumor biopsies may be repeated up to 3 times; these biopsies are optional. Participants will have follow-up visits every month for 3 months after treatment ends. They will continue to have imaging scans every 3 months; these scans may be done close to home. The results can be sent to researchers. Participants will remain in the study up to 6 years.
Primary Outcome
Number of DLTs within DLT period
Conditions Studied
Interventions
- DRUG Sasanlimab
- DRUG Palbocicilib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What NCT05665361 shows while recruiting
NCT05665361 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 2 conditions, with Advanced Clear Cell Renal Carcinoma (Ccrcc) appearing as the primary indexed condition, and to 2 interventions - of which Sasanlimab is the first listed.
NCT05665361 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05665361 about?
NCT05665361 is a clinical study titled "Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)". Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments. Better treatments are needed. Objective: To test a pair of drugs (sasanlimab and palbociclib) in people with kidney cancers. Eligibility...
What is the current status of trial NCT05665361?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-04-24. Estimated completion is 2027-06-01.
What conditions does trial NCT05665361 study?
This clinical trial studies the following conditions: Advanced Clear Cell Renal Carcinoma (Ccrcc), Papillary Renal Cell Carcinoma (Prcc).
What interventions are being tested in trial NCT05665361?
The interventions under investigation include: Sasanlimab (DRUG), Palbocicilib (DRUG).
Who is sponsoring clinical trial NCT05665361?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05665361 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05665361's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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