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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

Must not have

Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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I am eligible to continue or switch to atezolizumab therapy as my current study ends.

Exclusion Criteria

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

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I had to stop a previous study treatment due to lasting side effects.

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The treatment for my condition is available and I can get it in my country.

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I haven't received any cancer treatments not allowed in the main study before starting the extension study.

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I stopped taking atezolizumab for any reason after the initial study.

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

No Placebo-Only Group

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

Pivotal Trial

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

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

~5540

Atezolizumab

2016

Completed Phase 3

~5860