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Study of PF-08634404 for Advanced Kidney Cancer

This study is investigating PF-08634404, a new treatment for adults with advanced renal cell carcinoma (RCC), a type of kidney cancer that has spread locally or to other parts of the body. Researchers want to understand the safety of PF-08634404 when given alone or with other anti-cancer medicines like Ipilimumab or Axitinib, and how well these treatments work against the cancer. To join, you must be an adult with locally advanced or metastatic RCC and have not received prior treatment for your advanced kidney cancer. The study will measure how many participants respond to the treatment and track any side effects over approximately three years. The medicines will be given through an IV (intravenous) infusion.

Study design
This interventional study plans to enroll 224 participants. It is designed to test PF-08634404 alone and in combination with other therapies.
What's involved
Participants will receive study medicine through IV infusions. The study will monitor for side effects and treatment response for up to approximately three years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events and serious adverse events for up to 90 days after the last study intervention, which could be up to approximately three years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227415

Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~224 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:PF-08634404IpilimumabAxitinib

At a glance

Recruiting sites
101 of 128 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
Measured over Up to approximately 3 years
+2 more outcomes measured

Conditions

Carcinoma, Renal Cell
Advanced Renal Cell Carcinoma
Renal Cancer
Renal Neoplasm
Clear Cell Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Clear-cell Metastatic Renal Cell Carcinoma
Carcinoma, Renal Cell Metastasis
Advanced or Metastatic Renal Cell Carcinoma
Carcinoma, Renal Cell, Advanced
Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma ( mRCC)
Metastatic/Advanced Renal Cell Carcinoma

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Renal Cell Carcinoma

Where it's being run

128 sites across 33 states
Tennessee24
Texas22
California16
Minnesota9
New York9
Virginia6
Florida4
Arkansas3

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Eligibility criteria

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

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

What this trial measures

  • Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigatorUp to approximately 3 years

    ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.

  • Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Through 90 days after the last study intervention (Up to approximately 3 years)

    AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

  • Number of participants with dose limiting toxicity (DLT)Though end of DLT evaluation period (Up to approximately 3 years)

    The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).