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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

Must not have

Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient

Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

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 agree to not have unprotected sex or donate sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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The treatment I am considering is available and approved for my condition in my country.

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I stopped taking atezolizumab for any reason during or after the previous study.

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I haven't received any cancer treatment between my last study and this one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Venetoclax

2019

Completed Phase 3

~2240