A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.
2 other identifiers
interventional
146
12 countries
50
Brief Summary
This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
Typical duration for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
May 27, 2015
CompletedMay 27, 2015
May 1, 2015
3.2 years
November 21, 2008
August 4, 2014
May 22, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
12 and 24 months
PFS - Percentage of Participants With an Event
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
PFS - Time to Event
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Secondary Outcomes (6)
Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS - Percentage of Participants With an Event
Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS - Time to Event
Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- metastatic RCC with majority (\>50%) of conventional clear-cell type;
- prior total nephrectomy for primary RCC;
- at least one measurable or non-measurable lesions;
- ECOG performance score of 0 or 2.
You may not qualify if:
- prior systemic treatment for metastatic RCC;
- current or previously treated but non-stable CNS metastases or spinal cord compression;
- major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
- significant cardiovascular disease within 6 months prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Unknown Facility
Olomouc, 775 20, Czechia
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Prague, 128 08, Czechia
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Tallinn, 10617, Estonia
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Tallinn, 13419, Estonia
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Tartu, 50406, Estonia
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Seinäjoki, 60220, Finland
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Turku, 20520, Finland
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Arnsberg, 59755, Germany
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Augsburg, 86156, Germany
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Berlin, 10117, Germany
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Berlin, 13055, Germany
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Freiburg im Breisgau, 79106, Germany
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Homburg/Saar, 66424, Germany
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Leipzig, 04103, Germany
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München, 81241, Germany
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Münster, 48149, Germany
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Offenburg, 77652, Germany
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Planegg, 82152, Germany
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Stuttgart, 70174, Germany
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Weiden, 92637, Germany
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Larissa, 41 110, Greece
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Thessaloniki, 54639, Greece
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Thessaloniki, 56429, Greece
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Milan, 20100, Italy
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Napoli, 80131, Italy
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Pisa, 56100, Italy
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Kaunas, 50009, Lithuania
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Vilnius, 08661, Lithuania
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Amstelveen, 1186 AH, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Maastricht, 6229 HX, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Barnaul, 656049, Russia
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Moscow, 115478, Russia
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Moscow, 117837, Russia
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Moscow, 125284, Russia
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Obninsk, 249020, Russia
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Saint Petersburg, Russia
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Ufa, 450054, Russia
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Ulyanovsk, 432063, Russia
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Yekaterinburg, 620102, Russia
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Eskilstuna, 63188, Sweden
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Linköping, 58185, Sweden
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Sundsvall, 85186, Sweden
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Vaxjo, 35185, Sweden
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Aarau, 5000, Switzerland
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Locarno, 6601, Switzerland
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Zurich, 8063, Switzerland
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Cambridge, CB2 2QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
Related Publications (1)
Melichar B, Bracarda S, Matveev V, Alekseev B, Ivanov S, Zyryanov A, Janciauskiene R, Fernebro E, Mulders P, Osborne S, Jethwa S, Mickisch G, Gore M, van Moorselaar RJ, Staehler M, Magne N, Bellmunt J; BEVLiN Investigators. A multinational phase II trial of bevacizumab with low-dose interferon-alpha2a as first-line treatment of metastatic renal cell carcinoma: BEVLiN. Ann Oncol. 2013 Sep;24(9):2396-402. doi: 10.1093/annonc/mdt228. Epub 2013 Jun 26.
PMID: 23803225DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 27, 2015
Results First Posted
May 27, 2015
Record last verified: 2015-05