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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Concentrate for solution for infusion
Solution for infusion
Tablet
Tablet
Mayo Clinic Building- Phoenix
Phoenix, Arizona, United States
RECRUITINGMayo Clinic Arizona
Scottsdale, Arizona, United States
RECRUITINGHighlands Oncology Group
Fayetteville, Arkansas, United States
RECRUITINGHighlands Oncology Group
Rogers, Arkansas, United States
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
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.
Time frame: Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Time frame: Through 90 days after the last study intervention (Up to approximately 3 years)
Number of participants with dose limiting toxicity (DLT)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Time frame: Though end of DLT evaluation period (Up to approximately 3 years)
Duration of Response (DOR) per RECIST v1.1 by investigator
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall Survival (OS)
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
Time frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
Pharmacokinetics (PK): Serum concentration of PF-08634404
Pre-dose and post dose concentrations of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
To evaluate the immunogenicity of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
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Highlands Oncology Group, PA
Springdale, Arkansas, United States
RECRUITINGCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
RECRUITINGCity of Hope Investigational Drug Services (IDS)
Duarte, California, United States
RECRUITINGUC San Diego Medical Center - Encinitas
Encinitas, California, United States
RECRUITINGCity of Hope at Irvine Lennar
Irvine, California, United States
RECRUITINGCity of Hope Investigational Drug Services (IDS)
Irvine, California, United States
RECRUITING...and 152 more locations