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Atezolizumab Continuation for Cancer (IMbrella B Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol or Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent

For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to 90 days after last dose of study treatment (last dose=until 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

IMbrella B Trial Summary

This trial is for patients who are already receiving atezolizumab and are benefiting from it, and who would not have access to the treatment otherwise. The trial is designed as an extension of a previous study.

Who is the study for?

This trial is for patients who were part of a previous Genentech/Roche study and benefited from Atezolizumab or other cancer treatments. They must not have access to these drugs locally, be able to continue treatment without health risks, and agree to contraception if applicable. Pregnant women or those with unresolved serious side effects are excluded.Check my eligibility

What is being tested?

The extension study allows participants who saw benefits from Atezolizumab alone or in combination with other drugs in prior trials to continue receiving them. It's open-label and multicenter, meaning both the researchers and participants know what treatment is being given.See study design

What are the potential side effects?

Potential side effects include typical reactions related to cancer therapies such as fatigue, nausea, skin reactions, potential liver issues (hepatitis), nerve damage (neuropathy), blood clots, high blood pressure (hypertension), and immune-related effects.

IMbrella B Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible to continue my current atezolizumab therapy or another study drug as per my initial study's protocol.

Select...

I agree to not have unprotected sex or donate sperm.

IMbrella B Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to 90 days after last dose of study treatment (last dose=until 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to 90 days after last dose of study treatment (last dose=until 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=until 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

Number of Treatment Cycles

Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0

Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

+2 more

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

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Musculoskeletal chest pain

Respiratory tract infection

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

IMbrella B Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Combined Agents with AtezolizumabExperimental Treatment14 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 receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group III: Comparator TreatmentActive Control9 Interventions

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

Venetoclax

2019

Completed Phase 3

~1990

Emactuzumab

2015

Completed Phase 1

~260

Bevacizumab

2013

Completed Phase 4

~5280

Alectinib

2015

Completed Phase 3

~2400

Paclitaxel

2011

Completed Phase 4

~5380

Cobimetinib

2017

Completed Phase 3

~3090

Enzalutamide

2014

Completed Phase 4

~2760

Atezolizumab

2017

Completed Phase 3

~5860

Vemurafenib

2015

Completed Phase 3

~3540

Niraparib

2018

Completed Phase 4

~1540

Cabozantinib

2020

Completed Phase 2

~1760

Pemetrexed

2014

Completed Phase 3

~5250

Rucaparib

2016

Completed Phase 3

~1990

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,433 Previous Clinical Trials

1,089,197 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,202 Previous Clinical Trials

887,914 Total Patients Enrolled

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03768063 — Phase 3

Cancer Research Study Groups: Atezolizumab Monotherapy, Combined Agents with Atezolizumab, Comparator Treatment

Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03768063 — Phase 3

Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03768063 — Phase 3

Frequently Asked Questions

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

Has the FDA endorsed Atezolizumab for use?

"Our experts at Power have assessed the safety of Atezolizumab to be a 3 due its Phase 4 trial status, signifying that it has been approved for use."

Answered by AI

For what medical issues is Atezolizumab typically prescribed?

"Atezolizumab has been found to be a viable treatment for small cell lung cancer, malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

Are there still available slots in this research study for participants?

"As detailed on clinicaltrials.gov, recruitment for this medical trial remains open. It was initially announced on February 28th 2019 and its details were most recently updated November 15th 2022."

Answered by AI

Is this an original trial not previously conducted?

"Atezolizumab was initially studied in 2008, backed by Hoffmann-La Roche. After the initial study with 720 participants, Atezolizumab secured Phase 2 approval and is now being tested across 1646 cities in 74 countries through 350 active trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

2019. "A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03768063.

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