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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02133742

Run by

Pfizer

People needed

52

Starts

2014-09-16

Expected to finish

2019-07-03

Last updated by the study team

2021-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Controlled hypertension

You may not qualify if…

• Prior treatment with systemic therapy for advanced RCC
• Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
• Prior treatment with any agent specifically targeting T-cell co-stimulation or checkpoint pathways
• Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
• Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment intervention
• In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
• In past 6 months: deep vein thrombosis or pulmonary embolism

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Attn. Alicia Sammarco, RPh, NYU Investigational Pharmacy — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• NYU Langone — New York, New York, United States
• Investigational Drug Services — Columbus, Ohio, United States
• James Cancer Hospital — Columbus, Ohio, United States
• The Ohio State University Brain and Spine Hospital — Columbus, Ohio, United States
• Martha Morehouse Medical Plaza — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States
• Vanderbilt Oncology Pharmacy — Nashville, Tennessee, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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