A Phase 1/2 interventional study of PF-08634404 and Ipilimumab in Carcinoma, Renal Cell, Advanced Renal Cell Carcinoma and Renal Cancer, sponsored by Pfizer. Recruiting at 162 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pfizer · Phase 1/2, Interventional, and Treatment
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.
To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.
Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
Exclusion Criteria:
Participants may be excluded if they meet any of the following:
Participants will receive PF-08634404 IV.
Drug: PF-08634404
Participants will receive PF-08634404 in combination with ipilimumab.
Drug: PF-08634404 · Drug: Ipilimumab
Participants will receive PF-08634404 IV in combination with axitinib.
Drug: PF-08634404 · Drug: Axitinib
Participants will receive PF-08634404 in combination with Casdatifan.
Drug: PF-08634404 · Drug: Casdatifan
Concentrate for solution for infusion
Also known as: SSGJ-707
Solution for infusion
Also known as: yervoy
Tablet
Tablet
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
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.
Time frame: Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Time frame: Through 90 days after the last study intervention (Up to approximately 3 years)
Number of participants with dose limiting toxicity (DLT)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Time frame: Though end of DLT evaluation period (Up to approximately 3 years)
Duration of Response (DOR) per RECIST v1.1 by investigator
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall Survival (OS)
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
Time frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
Pharmacokinetics (PK): Serum concentration of PF-08634404
Pre-dose and post dose concentrations of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
To evaluate the immunogenicity of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Showing the first 100 of 162 sites across 6 countries.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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