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RecruitingLast updated: 22 July 2026

Symbiotic-GU-08: Studying a new medicine called PF-08634404 on its own or with other cancer medicines for people with advanced kidney cancer (renal cell carcinoma).AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

Symbiotic-GU-08

Clinical summary

Summary

This study is looking at a new medicine called PF-08634404 for people with advanced renal cell carcinoma (RCC), which is the most common type of kidney cancer.
 
Researchers want to learn:
  • How safe PF-08634404 is
  • How well it works against kidney cancer
  • Whether it works better when given on its own or together with other anti-cancer medicines
 
Who can take part?
You may be able to join this study if:
  • You are an adult
  • You have renal cell carcinoma (kidney cancer)
  • Your cancer has spread to nearby tissues (locally advanced) or other parts of the body (metastatic)
  • You have not received treatment for your advanced kidney cancer before
What does taking part involve?
Participants will be randomly assigned (by chance) to receive one of the following treatments:
  • PF-08634404 on its own;
  • PF-08634404 with ipilimumab, 
  • PF-08634404 with axitinib.
All treatment and study visits will take place at the clinical trial site. Participants will be monitored by trained healthcare professionals throughout the study and during treatment visits.
 

 

Conditions

This trial is treating people with renal cell carcinoma

Eligibility

Inclusion

  • 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

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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07227415 *
  • 2025-523524-53-00 *
  • C6461008; SYMBIOTIC-GU-08

Trial sponsor

Pfizer

Scientific Title

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

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