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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
EU CTIS ID: 2025-523524-53-00
What this study is testing
- 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).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
- Acute, chronic or symptomatic infections
- Participants with history of immunodeficiency
- 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.
See the full eligibility 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.
- Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
- Acute, chronic or symptomatic infections
- Participants with history of immunodeficiency
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- China
- United Kingdom
- Japan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; China; United Kingdom; Japan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.