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

Conditions

• Advanced Renal Cell Carcinoma
• Advanced or Metastatic Renal Cell Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Renal Cell Metastasis
• Carcinoma, Renal Cell, Advanced
• Clear Cell Renal Cell Carcinoma
• Clear-cell Metastatic Renal Cell Carcinoma
• Metastatic Renal Cell Cancer
• Metastatic Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma ( mRCC)
• Metastatic/Advanced Renal Cell Carcinoma
• Renal Cancer
• Renal Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08634404 — DRUG
  Concentrate for solution for infusion
• Ipilimumab — DRUG
  Solution for infusion
• Axitinib — DRUG
  Tablet

Study Details

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.

Key Dates

Start date

Feb 10, 2026

Status verified

Jun 2026

Primary completion

Nov 2, 2027

Completion

Nov 1, 2028

Study Design

Enrollment

224 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Participants will receive PF-08634404 IV.
• Experimental: Cohort B
  Participants will receive PF-08634404 in combination with ipilimumab.
• Experimental: Cohort C
  Participants will receive PF-08634404 IV in combination with axitinib.

Primary Outcome Measure

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator [ Time Frame: Up to approximately 3 years ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (101)

Find similar trials in Phoenix, AZ

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