Renal Cell CancerNCT02627144

Bevacizumab in Metastatic Renal Cancer

An observational study of Renal Cell Cancer, run by Hoffmann-La Roche at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Cancer
What is being tested?: Bevacizumab and Interferon alpha-2a
Type of treatment: Injection or infusion
How many people: 365 participants
Where: 1 siteGermany
Study dates: Jan 2008to Sep 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with advanced and/or metastatic renal cell cancer

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Freiburg im Breisgau, 79106

Other trials in Germany

About this study

Official title: AVASTIN® First Line in Metastatic Renal Cancer

Conditions: Renal Cell Cancer
Being tested: Bevacizumab, Interferon alpha-2a
Keywords: Metastatic renal cell carcinoma, Avastin, Bevacizumab
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02627144
Study group	Role	What they receive
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. Receives: Drug: Bevacizumab; Drug: Interferon alpha-2a

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Sep 2014

First posted10 Dec 2015 (estimated)
Study startJan 2008
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Cell CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02627144
Sponsor's protocol ID: ML21519
Status last verified: Jul 2016
First submitted: 8 Dec 2015
Last updated: 29 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 30711970

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia

All Renal Cell Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AVASTIN® First Line in Metastatic Renal Cancer
ClinicalTrials.gov ID: NCT02627144
Acronym / sponsor ID: ML21519
Conditions: Renal Cell Cancer
Keywords: Metastatic renal cell carcinoma, Avastin, Bevacizumab
Study type: Observational
Recruitment status: Completed
Enrolment: 365 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 10 Dec 2015 (estimated)
Results: Posted 12 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Advanced and/or Metastatic RCC participants	–	Drug: Bevacizumab, Drug: Interferon alpha-2aParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with advanced and/or metastatic renal cell cancer

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BevacizumabAlso: AvastinBevacizumab 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.	Drug	Advanced and/or Metastatic RCC participants
Interferon alpha-2aInterferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.	Drug	Advanced and/or Metastatic RCC participants

Primary outcome

Percentage of Participants With Best Overall Tumor Response
Time frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
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.
Percentage of Participants With Disease Control
Time frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
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.
Progression-free Survival (PFS) Time
Time frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years
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.
Overall Survival (OS) Time
Time frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years
OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine
Time frame: Up to 52 weeks

Results and safety

Results posted to the registry on 12 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Advanced and/or Metastatic RCC Participants	365	0

Primary outcome: Percentage of Participants With Best Overall Tumor Response

Time frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years. Number. Unit: percentage of participants

Measure	Advanced and/or Metastatic RCC Participants n = 338
CR	5.3
PR	21.9
SD	39.1
PD	16.6
Not Evaluable	17.2

Population analysed: Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.

Primary outcome: Percentage of Participants With Disease Control

Time frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years. Number. Unit: percentage of participants

Measure	Advanced and/or Metastatic RCC Participants n = 338
Value	66.3

Population analysed: FAS. 'Number of participants analyzed' indicate participants who were evaluable for this measure.

Primary outcome: Progression-free Survival (PFS) Time

Time frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years. Median (95% Confidence Interval). Unit: months

Measure	Advanced and/or Metastatic RCC Participants n = 354
Value	10.2 (8.6 to 12.6)

Population analysed: FAS

Primary outcome: Overall Survival (OS) Time

Time frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years. Median (95% Confidence Interval). Unit: months

Measure	Advanced and/or Metastatic RCC Participants n = 354
Value	28.7 (24.5 to 38.3)

Population analysed: FAS

Adverse events

Time frame: Baseline up to 6 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advanced and/or Metastatic RCC Participants	72 of 359 (20.1%)	325 of 359 (90.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30711970Schultze-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.

Related trials for Renal Cell Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Cancer, run by Hoffmann-La Roche at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Best Overall Tumor Response (time frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.