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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Rare Cancers

Phase 2

Waitlist Available

Led By Kanwal P Raghav, MD

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

Must not have

Various medical history exclusions including autoimmune diseases, organ transplantation, pulmonary conditions, infectious diseases, and cardiovascular conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I do not have autoimmune diseases, organ transplants, serious lung, infectious, or heart conditions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Duration of response

Incidence of adverse events

Objective response

+2 more

Other study objectives

Predictive and prognostic biomarkers in blood and tumor tissue

Side effects data

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

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group

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

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

~5540

Atezolizumab

2016

Completed Phase 3

~5860