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
NCT ID: NCT07227415
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
224 participants
INTERVENTIONAL
2025-12-04
2028-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A
Participants will receive PF-08634404 IV.
PF-08634404
Concentrate for solution for infusion
Cohort B
Participants will receive PF-08634404 in combination with drug 1.
PF-08634404
Concentrate for solution for infusion
Combination 1
Combination Drug 1
Cohort C
Participants will receive PF-08634404 IV in combination with drug 2.
PF-08634404
Concentrate for solution for infusion
Combination 2
Combination Drug 2
Interventions
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PF-08634404
Concentrate for solution for infusion
Combination 1
Combination Drug 1
Combination 2
Combination Drug 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Central Contacts
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Other Identifiers
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2025-523524-53-00
Identifier Type: CTIS
Identifier Source: secondary_id
C6461008
Identifier Type: -
Identifier Source: org_study_id