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

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08634404: Concentrate for solution for infusion

Ipilimumab: Solution for infusion

Axitinib: Tablet

Casdatifan: Tablet

Study summary

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.

Eligibility

Primary outcome measure(s)

• Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator — Up to approximately 3 years
  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.
• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through 90 days after the last study intervention (Up to approximately 3 years)
  AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
• Number of participants with dose limiting toxicity (DLT) — Though end of DLT evaluation period (Up to approximately 3 years)
  The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).

Trial sites (183)

+ 143 more sites — see the full list on the official registry below.

On this site

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