Study on PF-08634404 Alone and with Other Cancer Treatments for Advanced Kidney Cancer

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT07227415

This clinical trial is exploring a new medicine, PF-08634404, to see how it works in adults with advanced kidney cancer. The study will test the safety of the medicine when used alone or with other cancer treatments, and how well the cancer responds.

Patient Parameters

Program Overview

The purpose of this study is to test a new medicine called PF-08634404 in adults with advanced kidney cancer, known as Renal Cell Carcinoma (RCC). This type of cancer has either spread to nearby tissues or to other parts of the body. Researchers want to see if the medicine is safe and how well it works when given alone or with other cancer treatments. Participants will receive the medicine through an IV, which means it will be injected directly into a vein. All treatments will be done at clinical study sites, where medical staff will care for participants during and after each visit.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have advanced kidney cancer that cannot be cured with surgery or radiation, or has spread to other parts of the body.
  • Have at least one measurable and untreated tumor.
  • Have good blood, liver, heart, and kidney function.
  • Have not received any prior treatment for advanced kidney cancer, except for certain immunotherapy after surgery if it was more than 12 months ago.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Fit into any risk category based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC).

Exclusion Criteria

  • Have active cancer in the brain or spinal cord.
  • Have a high risk of bleeding or developing a fistula.
  • Have had another cancer within the past 3 years.
  • Have had an organ or stem cell transplant.
  • Have active autoimmune diseases needing treatment in the past 2 years.
  • Have uncontrolled heart or other serious health issues in the past 6 months.
  • Have had major surgery or severe injury in the past 4 weeks, or plan to have major surgery during the study.
  • Have a history of severe bleeding problems.
  • Have had serious digestive issues like ulcers or bleeding in the past 6 months.
  • Have active or serious infections.
  • Have a history of immune system problems.

Locations

FACILITYZIPCITYSTATE
Highlands Oncology Group72703FayettevilleArkansas
Highlands Oncology Group72758RogersArkansas
Highlands Oncology Group72762SpringdaleArkansas
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)91010DuarteCalifornia
City of Hope Investigational Drug Services (IDS)91010DuarteCalifornia
City of Hope Investigational Drug Services (IDS)92618IrvineCalifornia
City of Hope92618IrvineCalifornia
Jacobs Medical Center (JMC)92093La JollaCalifornia
Koman Family Outpatient Pavilion (KOP)92093La JollaCalifornia
Moores Cancer Center92093La JollaCalifornia

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