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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2025-523524-53-00

ClinicalTrials.gov

NCT07227415

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Pharmacokinetic, Efficacy

- Cohort A: To determine the antitumor activity of PF-08634404 as monotherapy.
- Cohort A: To characterize the overall safety profile and tolerability of PF-08634404 as monotherapy.
- To evaluate safety and tolerability of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C) (Part 1 only)
- To characterize the overall safety profile and tolerability of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
- To evaluate the antitumor activity of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
- To identify the optimal dose of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C) (Part 2).

Secondary objectives 8

1. Cohort A: To evaluate additional measures of efficacy of PF-08634404 as monotherapy.
2. Cohort A: To evaluate additional measures of safety and tolerability of PF-08634404 as monotherapy.
3. Cohort A: To evaluate pharmacokinetics (PK) of PF-08634404 as monotherapy.
4. Cohort A: To evaluate the immunogenicity of PF- 08634404 as monotherapy
5. To evaluate additional measures of efficacy of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
6. To evaluate additional measures of safety and tolerability of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
7. To evaluate PK of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
8. To evaluate the immunogenicity of PF- 08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).

Conditions and MedDRA coding

ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Regulatory references

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 18 years of age or older at screening
2. Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
3. At least one measurable (as defined by the investigator) and untreated lesion
4. Adequate hematologic, hepatic, cardiac and renal function
5. No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received >12 months prior)
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories.

Exclusion criteria 11

1. Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
2. Clinically significant risk of haemorrhage or fistula
3. History of another malignancy within 3 years
4. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
5. Active autoimmune diseases requiring systemic treatment within the past 2 years
6. Uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
7. Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
8. History of severe bleeding tendency or coagulation dysfunction
9. History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess
10. Acute, chronic or symptomatic infections
11. Participants with history of immunodeficiency

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator
2. Cohort A: Adverse events (AEs) as characterized by type, frequency, intensity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, timing, seriousness, and relationship to study intervention(s)
3. Cohort B/C: Dose limiting toxicities (DLTs) in the first cycle (Part 1)
4. Cohort B/C: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
5. Cohort B/C: Confirmed ORR using RECIST 1.1 as assessed by investigator

Secondary endpoints 8

1. Cohort A: - Duration of response (DoR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS)
2. Cohort A: Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
3. Cohort A: Predose and post dose concentrations of PF-08634404.
4. Cohort A: Incidence of antidrug antibodies (ADA) against PF-08634404
5. Cohort B/C: - DoR using RECIST 1.1 as assessed by investigator - PFS using RECIST 1.1 as assessed by investigator - OS
6. Cohort B/C: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
7. Cohort B/C: Predose and post dose concentrations of PF-08634404
8. Cohort B/C: Incidence of ADA against PF-08634404

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 11

Locations

2 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications