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
NCT ID: NCT02133742
Last Updated: 2021-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2014-09-16
2019-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
TREATMENT
NONE
Study Groups
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Dose finding phase and dose expansion phase
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
Axitinib at starting dose of 5 mg and 3 mg BID.
MK-3475
MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.
Interventions
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Axitinib
Axitinib at starting dose of 5 mg and 3 mg BID.
MK-3475
MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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References
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Atkins MB, Plimack ER, Puzanov I, Fishman MN, McDermott DF, Cho DC, Vaishampayan U, George S, Tarazi JC, Duggan W, Perini R, Thakur M, Fernandez KC, Choueiri TK. Axitinib plus pembrolizumab in patients with advanced renal-cell carcinoma: Long-term efficacy and safety from a phase Ib trial. Eur J Cancer. 2021 Mar;145:1-10. doi: 10.1016/j.ejca.2020.12.009. Epub 2021 Jan 4.
Martini JF, Plimack ER, Choueiri TK, McDermott DF, Puzanov I, Fishman MN, Cho DC, Vaishampayan U, Rosbrook B, Fernandez KC, Tarazi JC, George S, Atkins MB. Angiogenic and Immune-Related Biomarkers and Outcomes Following Axitinib/Pembrolizumab Treatment in Patients with Advanced Renal Cell Carcinoma. Clin Cancer Res. 2020 Nov 1;26(21):5598-5608. doi: 10.1158/1078-0432.CCR-20-1408. Epub 2020 Aug 18.
Atkins MB, Plimack ER, Puzanov I, Fishman MN, McDermott DF, Cho DC, Vaishampayan U, George S, Olencki TE, Tarazi JC, Rosbrook B, Fernandez KC, Lechuga M, Choueiri TK. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018 Mar;19(3):405-415. doi: 10.1016/S1470-2045(18)30081-0. Epub 2018 Feb 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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KN-035
Identifier Type: OTHER
Identifier Source: secondary_id
A4061079
Identifier Type: -
Identifier Source: org_study_id
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