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

Introduction

• Org Study ID: 10000666
• NTC ID: NCT05665361
• Lead Sponsor Name: National Cancer Institute (NCI)
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma

Brief 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 Criteria

* INCLUSION CRITERIA:
* Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)
* Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1.
* Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)
* Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC
* Age >= 18 years
* ECOG performance status = 1,000/microliter
* Hemoglobin (Hb) >= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation
* Platelets >= 100,000/microliter
* Adequate renal and hepatic function at screening, as follows:

* Serum creatinine 1.5x ULN, creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2 (calculated CrCl (CKD-EPI or calculated eGFR provided by laboratory))
* Total bilirubin