NCT02627144

Brief Summary

This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 12, 2016

Completed
Last Updated

August 29, 2016

Status Verified

July 1, 2016

Enrollment Period

6.7 years

First QC Date

December 8, 2015

Results QC Date

June 2, 2016

Last Update Submit

July 26, 2016

Conditions

Renal Cell Cancer

Keywords

Metastatic renal cell carcinomaAvastinBevacizumab

Outcome Measures

Primary Outcomes (5)

  • Percentage of Participants With Best Overall Tumor Response

    Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

    Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years

  • Percentage of Participants With Disease Control

    Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

    Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years

  • Progression-free Survival (PFS) Time

    PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

    Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years

  • Overall Survival (OS) Time

    OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.

    Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years

  • Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine

    Up to 52 weeks

Study Arms (1)

Advanced and/or Metastatic RCC participants

Participants with mRCC who are being treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression will be observed. No diagnostic or therapeutic interventions will be given other than used in normal daily routine.

Drug: BevacizumabDrug: Interferon alpha-2a

Interventions

BevacizumabDRUG

Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.

Also known as: Avastin
Advanced and/or Metastatic RCC participants
Interferon alpha-2aDRUG

Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.

Advanced and/or Metastatic RCC participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with advanced and/or metastatic renal cell cancer

You may qualify if:

  • Histologically confirmed advanced and/or metastatic renal cell cancer
  • No contraindications for Avastin according to summary of product characteristics (SmPC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (1)

  • Schultze-Seemann W, Schulz H, Tschechne B, Hackl M. Bevacizumab plus IFN-alpha-2a in First-line Treatment of Patients With Advanced or Metastatic Renal Cell Carcinoma: A Prospective German Non-interventional Study. Anticancer Res. 2019 Feb;39(2):875-882. doi: 10.21873/anticanres.13188.

    PMID: 30711970DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

BevacizumabInterferon alpha-2

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 10, 2015

Study Start

January 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 29, 2016

Results First Posted

July 12, 2016

Record last verified: 2016-07

Locations

DE(1)