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

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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-?, 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).

NCT02493751
Pfizer
Active, not recruiting
A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now