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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
Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
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
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I am eligible to continue my current atezolizumab therapy or another study drug as per my initial study's protocol.
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I am currently benefiting from my atezolizumab-based treatment as assessed by my doctor.
Select...
I agree to not have unprotected sex or donate sperm.

IMbrella B Trial 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)
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
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Emactuzumab
2015
Completed Phase 1
~260
Cabozantinib
2020
Completed Phase 2
~1080
Bevacizumab
2013
Completed Phase 4
~5280
Rucaparib
2016
Completed Phase 3
~1990
Niraparib
2018
Completed Phase 4
~1540
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~5250
Venetoclax
2019
Completed Phase 3
~1990
Cobimetinib
2015
Completed Phase 3
~2630
Vemurafenib
2015
Completed Phase 3
~3100
Enzalutamide
2014
Completed Phase 4
~2760
Alectinib
2015
Completed Phase 3
~2400
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,151 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
887,591 Total Patients Enrolled

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03768063 — Phase 3
Cancer Research Study Groups: Combined Agents with Atezolizumab, Comparator Treatment, Atezolizumab Monotherapy
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
~455 spots leftby Jul 2028