Study on Palbociclib and Sasanlimab for Treating Advanced Kidney Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05665361

Provider View

This clinical trial is testing a combination of two drugs, palbociclib and sasanlimab, to see if they can help treat advanced kidney cancers, specifically clear cell renal cell carcinoma (ccRCC) and papillary renal cell carcinoma (pRCC).

Patient Parameters

Program Overview

The study aims to find out if the drugs palbociclib and sasanlimab can effectively treat advanced kidney cancers that have not responded well to current treatments. Participants will take palbociclib as a daily pill and receive sasanlimab as a monthly injection. The trial will last up to two years, with regular check-ups and tests to monitor progress.

Description

Kidney cancer is a common type of cancer, and new treatments are needed for those that don't respond to current therapies. This study is testing two drugs, palbociclib and sasanlimab, to see if they can help treat advanced kidney cancers, specifically clear cell renal cell carcinoma (ccRCC) and papillary renal cell carcinoma (pRCC).

Palbociclib is a pill that helps stop cancer cells from growing by blocking certain proteins. Sasanlimab is an injection that helps the immune system attack cancer cells. Participants will take palbociclib daily for 21 days in a 28-day cycle and receive a sasanlimab injection at the start of each cycle. The treatment will last up to two years, with regular scans and tests to check on the cancer's response.

Participants will have follow-up visits every month for three months after treatment ends and continue to have scans every three months, which can be done locally. The study will last up to six years, including follow-up.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older with advanced clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC).
  • Must have at least one measurable tumor.
  • For ccRCC, must have tried checkpoint inhibitor therapy and a VEGF pathway antagonist.
  • For pRCC, can be new to treatment or have had previous systemic treatment.
  • No more than two prior treatments for metastatic cancer.
  • Good overall health with adequate organ function.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Men must use condoms during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent treatment for kidney cancer with certain therapies within four weeks before starting the study.
  • More than two previous treatments for metastatic cancer.
  • Certain digestive issues that affect drug absorption.
  • Severe allergic reactions to similar drugs.
  • Active autoimmune diseases requiring treatment.
  • Use of certain medications that affect the immune system.
  • Previous organ transplants.
  • Current or past hepatitis B infection.
  • History of lung disease or tuberculosis.
  • Use of certain medications or supplements that interact with the study drugs.
  • Recent history of other cancers, except for certain non-threatening types.
  • Pregnant or breastfeeding women.
  • Any serious health conditions that would interfere with the study.

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