Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05411081

Provider View

This study is exploring whether adding the immunotherapy drug atezolizumab to the usual treatment with cabozantinib can improve outcomes for patients with advanced papillary kidney cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This clinical trial is testing a new treatment approach for papillary kidney cancer that has spread beyond the kidney. The study compares the effects of using cabozantinib alone versus combining it with atezolizumab, an immunotherapy drug. Papillary kidney cancer is a type of cancer that forms in the kidney's tiny tubes. Atezolizumab may help the immune system attack cancer cells, while cabozantinib works by blocking proteins that help cancer cells grow and spread. The combination of these treatments may help shrink tumors and extend survival in patients with advanced kidney cancer.

Description

The main goal of this study is to see if the combination of cabozantinib and atezolizumab can help patients with advanced papillary kidney cancer live longer without the cancer getting worse, compared to cabozantinib alone.

Secondary goals include comparing overall survival rates and how well the tumors respond to the treatments. The study will also look at the side effects of each treatment option.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take cabozantinib pills daily for 21 days in each cycle. They will have regular CT and bone scans and may give blood samples throughout the study.
  • Group 2: Will take cabozantinib pills daily and receive atezolizumab through an IV on the first day of each cycle. They will also have regular CT and bone scans and may give blood samples.

Each cycle lasts 21 days, and treatment continues as long as it is effective and side effects are manageable. After finishing the study treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced papillary kidney cancer.
  • Must have measurable cancer that can be tracked using scans.
  • Must not need immediate treatment for brain metastases.
  • Must not have a history of bleeding in the brain or spinal cord.
  • Must be 18 years or older.
  • Must have a physical exam and medical history review before joining.
  • Must have a performance status score of 0-2, indicating good overall health.
  • Must meet specific blood count and organ function requirements.
  • Must have controlled blood pressure.
  • Must be able to take oral medications.
  • Must agree to provide blood and tissue samples for research.
  • Must understand the study and sign informed consent.

Exclusion Criteria

  • Must not have had recent brain or whole-body radiation or brain surgery.
  • Must not need ongoing steroid treatment for brain issues.
  • Must not have certain lung conditions or fluid buildup requiring frequent drainage.
  • Must not have tumors invading the digestive tract or major blood vessels.
  • Must not have had major surgery recently.
  • Must not have taken cabozantinib or certain other cancer drugs before.
  • Must not be taking certain medications that interact with the study drugs.
  • Must not have significant autoimmune diseases, except for some controlled conditions.
  • Must not have serious heart conditions or recent heart attacks.
  • Must not have had significant bleeding issues recently.
  • Must not be pregnant or breastfeeding and must agree to use effective birth control.
  • Must not be on certain blood thinners.

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