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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Rare Cancers

Phase 2

Waitlist Available

Led By Daniel M Halperin

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Liver and kidney function within specified limits

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is studying how well atezolizumab and bevacizumab work in treating patients with rare solid tumors.

Who is the study for?

This trial is for patients with rare solid tumors like certain types of lung, anal, cervical, and other cancers. Participants must have measurable disease growth, adequate liver/kidney function, and be able to follow the study plan. They should not have severe allergies or autoimmune diseases, recent cancer treatments or investigational therapies within 28 days prior to the study.Check my eligibility

What is being tested?

The trial tests how well atezolizumab (an immunotherapy drug) combined with bevacizumab (a drug that inhibits blood vessel growth in tumors) works against various rare solid tumors. It's a phase II study focusing on the effectiveness of these monoclonal antibodies in stopping tumor growth.See study design

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in organs; infusion reactions; increased risk of infections; possible bleeding issues due to interference with blood vessel formation; fatigue; and allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My liver and kidney are working well.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in targeted clinical laboratory test results

Change in targeted vital signs

Duration of response

+4 more

Other outcome measures

Predictive and prognostic biomarkers in blood and tumor tissue

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

65%

Infusion related reaction

59%

Neutrophil count decreased

41%

Upper respiratory infection

29%

Aspartate aminotransferase increased

29%

Platelet count decreased

24%

Alanine aminotransferase increased

18%

Sinusitis

18%

Urinary tract infection

12%

Tooth infection

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 and MTD (800 mg Entospletinib Daily)

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (atezolizumab, bevacizumab)Experimental Treatment4 Interventions

Patients receive atezolizumab and bevacizumab IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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