PF-08634404 alone and with other anticancer medicines for adults with advanced kidney cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 program gives PF-08634404 by IV either alone or combined with other anticancer agents to adults with locally advanced or metastatic renal cell carcinoma who are treatment‑naïve for advanced disease. Phase 1 will define safe dose(s) and monitor side effects, and Phase 2 will expand to look more closely at tumor responses and tolerability. Participants must have at least one measurable untreated lesion and adequate organ function, and will be seen regularly at clinic sites for infusions and safety checks. All treatments and monitoring are performed at the study sites by trained staff.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years of age or older at screening
* Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
* At least one measurable (as defined by the investigator) and untreated lesion
* Adequate hematologic, hepatic, cardiac and renal function
* No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \>12 months prior)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories

Exclusion Criteria:

Participants may be excluded if they meet any of the following:

* Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
* Clinically significant risk of haemorrhage or fistula
* History of another malignancy within 3 years
* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
* active autoimmune diseases requiring systemic treatment within the past 2 years
* uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
* Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
* History of severe bleeding tendency or coagulation dysfunction
* History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose
* Acute, chronic or symptomatic infections
* Participants with history of immunodeficiency

Where it's running

• Mayo Clinic Building- Phoenix
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• Highlands Oncology Group
  Fayetteville, Arkansas, United States Recruiting
• Highlands Oncology Group
  Rogers, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Springdale, Arkansas, United States Recruiting
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
  Duarte, California, United States Recruiting

+133 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.