A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:October 15, 2015
End Date:January 22, 2020

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A PHASE 1B, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (AG-013736) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED RENAL CELL CANCER

This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the
maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab
(MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered
in combination with axitinib is estimated (dose finding portion), the dose expansion phase
will be opened to further characterize the combination in term of safety profile, anti tumor
activity, pharmacokinetics, pharmacodynamics and biomarker modulation.


Inclusion Criteria:

- Histologically or cytologically confirmed advanced RCC with clear cell component

- Primary tumor resected

- Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block
from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a
RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue
block (not cut slides) from a primary or metastatic tumor resection or biopsy can be
provided if the following criteria are met: 1) the biopsy or resection was performed
within 1 year of enrollment AND 2) the patient has not received any intervening
systemic anti-cancer treatment from the time the tissue was obtained and enrollment
onto the current study. If an FFPE tissue block cannot be provided as per documented
regulations,, 15 unstained slides (10 minimum) will be acceptable.

- Availability of an archival FFPE tumor tissue block from primary diagnosis specimen
(if available and not provided per above). If an FFPE tissue block cannot be provided,
15 unstained slides (10 minimum) will be acceptable

- At least one measureable lesion as defined by RECIST version 1.1 that has not been
previously irradiated.

- Age ≥18 years (≥ 20 years in Japan).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow function, renal and liver functions

Exclusion Criteria:

- Prior systemic therapy directed at advanced RCC.

- Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has
occurred during or within 12 months after the last dose of treatment

- Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti
CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody
(including ipilimumab), or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways

- Prior therapy with axitinib as well as any prior therapies with other VEGF pathway
inhibitors.

- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any
history of anaphylaxis.

- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack, deep vein thrombosis or
symptomatic pulmonary embolism.

- Vaccination within 4 weeks of the first dose of avelumab and while on trial is
prohibited except for administration of inactivated vaccines (for example, inactivated
influenza vaccines).
We found this trial at
14
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Cleveland, OH
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chuo-ku, Niigata, Niigata 95185
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Nashville, Tennessee 37232
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New York, New York 10016
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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3800 Reservoir Road Northwest
Washington, District of Columbia 20007
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