A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Trial Summary
What is the purpose of this trial?
Despite substantial improvements of patients outcome in advanced RCC, durable and complete response is uncommon. The majority of patients eventually develop resistance and exhibit disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with axitinib may provide additional clinical benefit compared to axitinib alone.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Inclusion Criteria
Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected
At least one measureable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Eastern Cooperative Oncology Group performance status 0 or 1
See 1 more
Treatment Details
Interventions
- Axitinib (Tyrosine Kinase Inhibitor)
- MK-3475 (PD-1 Inhibitor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dose finding phase and dose expansion phaseExperimental Treatment2 Interventions
To test the maximum tolerated dose of MK-3475 at 2 mg/kg every three weeks intravenous infusion in combination with approved axitinib dose
Axitinib is already approved in European Union, United States, United Kingdom for the following indications:
🇪🇺 Approved in European Union as Inlyta for:
- Renal cell carcinoma
🇺🇸 Approved in United States as Inlyta for:
- Advanced renal cell carcinoma
🇬🇧 Approved in United Kingdom as Inlyta for:
- Advanced renal cell carcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallas, TX
H. Lee Moffitt Cancer Center & Research Institute, Inc.Tampa, FL
Georgetown University Medical CenterWashington, United States
Massachusetts General HospitalBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Merck Sharp & Dohme LLC
Industry Sponsor
Trials
4096
Patients Recruited
5,232,000+