A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer(JAVELIN Renal 101)

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NCT02684006

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Study Location
Southern Cancer Center
Daphne, Alabama, 36526, United States
See other locations
Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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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 or metastatic RCC with clear cell component

- 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 (cut slides not acceptable) 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 randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study.

- Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if 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.

- 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 or metastatic 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 and/or sunitinib as well as any prior therapies with
other vascular endothelial growth factor (VEGF) pathway inhibitors.


- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any
history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially
controlled asthma Global Initiative for Asthma 2011).


- 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).

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Intravenous injections
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Screening: Up to 28 days
Site Visits
Screening: At least 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Questionnaire
Keeping a diary
Mri
Cat scan
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Blood test
Vital signs and measurements
X-rays

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Renal Cell CancerA Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer(JAVELIN Renal 101)
NCT02684006
  1. Daphne, Alabama
  2. Mobile, Alabama
  3. Mobile, Alabama
  4. Beverly Hills, California
  5. Duarte, California
  6. Duarte, California
  7. Los Angeles, California
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  22. Metairie, Louisiana
  23. Metairie, Louisiana
  24. Brunswick, Maine
  25. Kennebunk, Maine
  26. Scarborough, Maine
  27. Baltimore, Maryland
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  90. Houston, Texas
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  96. Puyallup, Washington
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  101. Macquarie University, New South Wales
  102. Macquarie University, New South Wales
  103. Randwick, New South Wales
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Renal Cell CancerA Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
NCT02493751
  1. Scottsdale, Arizona
  2. Washington, District of Columbia
  3. Boston, Massachusetts
  4. Boston, Massachusetts
  5. Boston, Massachusetts
  6. New York, New York
  7. New York, New York
  8. Cleveland, Ohio
  9. Cleveland, Ohio
  10. Nashville, Tennessee
  11. Salt Lake City, Utah
  12. Salt Lake City, Utah
  13. Chuo-ku, Niigata, Niigata
  14. Osakasayama, Osaka
  15. Shinjuku-ku, Tokyo
  16. London, Middlesex
  17. Carshalton, Surrey
  18. London,
  19. London,
  20. Manchester,
  21. Sutton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Official Title  ICMJE A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
Brief Summary This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Cancer
Intervention  ICMJE
  • Drug: Avelumab (MSB0010718C)
    IV treatment Avelumab administered at 10 mg/kg IV every two weeks
  • Drug: Axitinib (AG-013736)
    Oral treatment Axitinib given 5 mg PO BID
    Other Name: Inlyta
  • Drug: Sunitinib
    Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
    Other Name: Sutent
Study Arms  ICMJE
  • Experimental: Avelumab in combination with axitinib
    Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
    Interventions:
    • Drug: Avelumab (MSB0010718C)
    • Drug: Axitinib (AG-013736)
  • Active Comparator: Sunitinib
    Sunitinib given at 50 mg PO QD on schedule 4/2
    Intervention: Drug: Sunitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 12, 2020)		893
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)		583
Estimated Study Completion Date  ICMJE May 21, 2024
Estimated Primary Completion Date May 21, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
  • Availability of a 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 randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
  • Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations 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
  • 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 or metastatic 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 and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
  • Newly dignosed or active brain metastasis
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ?3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
  • Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
  • Any of the following in the previous 6 months: 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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Romania,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02684006
Other Study ID Numbers  ICMJE B9991003
2015-002429-20 ( EudraCT Number )
JAVELIN RENAL 101 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP