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

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

Phase1; Phase2 Interventional Pfizer · NCT07227415

This tests whether PF-08634404, given alone or with other cancer medicines, is safe and helps adults with locally advanced or metastatic kidney cancer who have not had prior systemic treatment.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment224 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsimmunotherapy, radiation
Locations49 sites (Fayetteville, Arkansas and 48 other locations)
Trial IDNCT07227415 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18 or older with biopsy-confirmed locally advanced or metastatic renal cell carcinoma, at least one measurable untreated lesion, adequate organ function, ECOG 0–1, and no prior systemic therapy for advanced RCC.

Not a fit: People with active brain or leptomeningeal metastases, significant bleeding or fistula risk, recent other malignancies, prior systemic therapy for advanced RCC, or prior allogeneic transplantation are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, PF-08634404 could become a new first-line option that shrinks tumors or slows disease progression for people with advanced RCC.

How similar studies have performed: Other trials combining novel targeted or immune therapies with established anticancer drugs have shown benefit in RCC, but PF-08634404 itself is experimental and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* Acute, chronic or symptomatic infections
* Participants with history of immunodeficiency

Where this trial is running

Fayetteville, Arkansas and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Renal CellAdvanced Renal Cell CarcinomaRenal CancerRenal NeoplasmClear Cell Renal Cell CarcinomaMetastatic Renal Cell CarcinomaClear-cell Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell Metastasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.