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Bevacizumab + Atezolizumab for Cancer

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by sponsor, whichever occurs first) (up to maximum 10 years)
Awards & highlights

Study Summary

This trial is an extension of a previous study, for participants who are still receiving treatment and do not have access to the study treatment locally. The treatment will be the same as the previous study, and can continue until disease progression, withdrawal of study consent, unacceptable toxicity, pregnancy, patient non-compliance, or study termination by the Sponsor.

Who is the study for?
This trial is for cancer patients who were part of a previous Genentech/Roche Atezolizumab study and are still benefiting from the treatment. They must not have access to this medication commercially, should start the extension within 7 days after their last dose in the parent study, and cannot have unresolved severe side effects or other treatments interfering.Check my eligibility
What is being tested?
The trial continues treatment with Atezolizumab alone or combined with Bevacizumab for those previously enrolled in related studies. It's an open-label, non-randomized extension to assess long-term outcomes without changing the original dosing regimen until disease progression or unacceptable toxicity.See study design
What are the potential side effects?
Potential side effects include infusion reactions, increased risk of infections, bleeding issues due to Bevacizumab, fatigue, liver problems (hepatitis), heart complications like high blood pressure and heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible to continue or switch to atezolizumab therapy as my current study ends.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by sponsor, whichever occurs first) (up to maximum 10 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by sponsor, whichever occurs first) (up to maximum 10 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Secondary outcome measures
Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Combined Agents with AtezolizumabExperimental Treatment2 Interventions
Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Group II: Atezolizumab MonotherapyExperimental Treatment1 Intervention
Participants will continue to receive atezolizumab monotherapy in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.
Group III: Comparator TreatmentActive Control1 Intervention
Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,672 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,120 Total Patients Enrolled

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03148418 — Phase 3
Cancer Research Study Groups: Comparator Treatment, Atezolizumab Monotherapy, Combined Agents with Atezolizumab
Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03148418 — Phase 3
Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03148418 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the pioneering investigation of its type?

"Initially developed by Hoffmann-La Roche in 2008, the first trial of Atezolizumab included 720 participants. Subsequently securing Phase 2 drug approval, this medication has been researched extensively with 350 ongoing studies across 74 nations and 1646 cities."

Answered by AI

What is the usual purpose of Atezolizumab treatment?

"Atezolizumab can be applied therapeutically to combat small cell lung cancer (SCLC), malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

Are there any remaining opportunities for participants to join this experiment?

"Evidently, clinicaltrials.gov does not indicate that this trial is in need of participants at the time being; it was first posted on September 20th 2017 and most recently edited on the 15th of September 2022. Nevertheless, there are 836 other trials searching for patients currently."

Answered by AI

Are there various locations executing this clinical trial within the state?

"For this trial, patients can be accepted at Kaiser Permanente - San Diego (Zion Ave) in San Marcos, California; Dana Farber Cancer Inst. ; Dept. of Medical Oncology in Boston, Massachusetts; and HonorHealth Research Institute - Bisgrove in Scottsdale Arizona, among other 52 sites listed on the official website."

Answered by AI

How many participants are engaging in this research?

"This clinical trial is no longer actively searching for participants. It was originally posted on September 20th 2017 and last updated on the 15th of September 2022. Concerning other studies, there are currently 486 trials recruiting patients with cancerous tumours, as well as 350 investigations requiring Atezolizumab recipients."

Answered by AI

What potential adverse effects should patients be aware of when taking Atezolizumab?

"With Phase 4 clinical trial data supporting its use, Atezolizumab has been rated with a 3 for safety on our team's scale."

Answered by AI

Have there been any previous investigations involving Atezolizumab?

"Atezolizumab was first studied in 2008 by Peninsula and South Eastern Haematology and Oncology Group. Currently, there are 81 completed trials with 350 more actively recruiting patients, many of which taking place near San Marcos California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
2017. "A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03148418.
~179 spots leftby Mar 2030
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