Kidney Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

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
Controlled hypertension

Exclusion Criteria:

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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT02133742

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 13 Locations for this study

See Locations Near You

Georgetown University Medical Center
Washington District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa Florida, 33612, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Attn. Alicia Sammarco, RPh, NYU Investigational Pharmacy
New York New York, 10016, United States
NYU Langone Medical Center
New York New York, 10016, United States
NYU Langone
New York New York, 10016, United States
Investigational Drug Services
Columbus Ohio, 43210, United States
James Cancer Hospital
Columbus Ohio, 43210, United States
The Ohio State University Brain and Spine Hospital
Columbus Ohio, 43210, United States
Martha Morehouse Medical Plaza
Columbus Ohio, 43221, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Henry-Joyce Cancer Clinic
Nashville Tennessee, 37232, United States
Vanderbilt Oncology Pharmacy
Nashville Tennessee, 37232, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT02133742

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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