RecruitingPhase 1Phase 2NCT05665361

Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)

A Phase I/II Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)


Sponsor

National Cancer Institute (NCI)

Enrollment

100 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — palbociclib (a cell cycle inhibitor) and sasanlimab (an immunotherapy drug) — in people with advanced kidney cancer (clear cell or papillary types) that has come back or not responded to prior treatment. **You may be eligible if...** - You are 18 or older - You have confirmed advanced clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC) with at least one measurable tumor - For ccRCC: you have already received checkpoint immunotherapy and either received or were ineligible for VEGF-targeted therapy - For pRCC: you may have had prior treatment or be newly diagnosed - You are in good health (ECOG 0–1) - Your blood counts, kidney, and liver function meet the study requirements **You may NOT be eligible if...** - You have a different subtype of kidney cancer - For ccRCC: you have not previously received checkpoint immunotherapy - You are pregnant or breastfeeding - Your organ function does not meet the study's requirements - You have conditions that make the study drugs unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSasanlimab

Sasanlimab will be given (SC on day 1 of every cycle, starting on day 1 (+/- 5 days) of cycle 2).

DRUGPalbocicilib

Palbociclib will be given PO for 21 days of every 28-day cycle, starting on day 1 of cycle 1.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05665361