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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Advanced Head and Neck Cancer

Phase 2 & 3

Recruiting

Led By Aarti Bhatia

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients must not have untreated brain metastases or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing standard therapy (chemotherapy plus cetuximab) to adding bevacizumab to standard chemotherapy, versus a combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent).

Who is the study for?

Adults with advanced or recurrent head and neck cancers who have progressed after first-line immune therapy can join. They must not have had certain prior treatments, severe allergies to trial drugs, active infections, uncontrolled illnesses, or recent major surgeries. Eligible participants need functioning organs and no history of significant bleeding issues or organ transplants.

What is being tested?

The study compares standard chemotherapy plus cetuximab against adding bevacizumab to this regimen versus a combination of bevacizumab and atezolizumab alone. It aims to determine if these investigational therapies are more effective for patients whose cancer has spread or returned after treatment.

What are the potential side effects?

Potential side effects include allergic reactions to monoclonal antibodies, increased risk of infection due to immunotherapy agents like atezolizumab, bleeding from antiangiogenic agents like bevacizumab, as well as typical chemotherapy-related issues such as fatigue, nausea, blood cell count changes.

Eligibility Criteria

Inclusion Criteria

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

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My hepatitis B virus load is undetectable with treatment.

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My brain scans show no signs of cancer after treatment for brain metastases.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I have never had rapid cancer growth after starting immunotherapy.

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I have not had any major bleeding issues or tumors in critical areas.

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My calcium levels are controlled and within normal range.

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I don't need frequent procedures to remove excess fluid from my body.

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I do not have high blood pressure issues or a history of severe blood clot problems.

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I haven't had any major surgery or serious injury in the last 28 days and don't expect to need major surgery soon.

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I am 18 years old or older.

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I do not have a history of bleeding disorders.

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

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I am not on blood thinners for a past clot.

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I haven't had a severe infection or tuberculosis in the last 4 weeks.

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I have never needed high-dose steroids for lung inflammation.

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My cancer shows PD-L1 expression of 1% or more.

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My cancer is a specific type of throat or mouth cancer, not related to certain viruses or areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from randomization

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

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival (OS) (Phase III)

Secondary study objectives

Correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers

OS in the subset of patients with high PD-L1 expression (Phase III)

Prediction of treatment response

Other study objectives

Correlation between 18F-FDG PET and CT neck radiomics features and expression of PD-L1 expression

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956

43%

Leucopenia

43%

Weight Decreased

40%

Nausea

35%

Rash

34%

Hypomagnesaemia

32%

Hypokalemia

31%

Constipation

28%

Neutropenia

28%

Vomiting

26%

Decreased Appetite

22%

Pyrexia

19%

Hyponatremia

19%

Acne

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Fatigue

15%

Pruritus

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Dizziness

Cough

White Blood Cell Count Decreased

Hypochloremia

Dermatitis Acneiform

Hypocalcaemia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Oral Pain

Neck pain

Dyspnoea

Headache

Anaphylactic reaction

Microcytic anemia

Mouth hemorrhage

Staphylococcal skin infection

Pneumonitis

Pneumonia

Myocardial infarction

Pulmonary embolism

Electrolyte imbalance

Tumor hemorrhage

Respiratory alkalosis

Toxic encephalopathy

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase

Cetuximab + Cisplatin + 5-FU : Late Phase

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)Experimental Treatment9 Interventions

Patients receive treatment as in Arm B or C above based on results of the Phase II trial.

Group II: Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)Experimental Treatment9 Interventions

Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Group III: Phase II, Arm C (Bevacizumab, Atezolizumab)Experimental Treatment7 Interventions

Patients receive bevacizumab IV over 30-90 minutes on day 1 and atezolizumab over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Group IV: Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab)Experimental Treatment9 Interventions

Patients receive bevacizumab IV over 30-90 minutes on day 1 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-60 minutes on day 1 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Group V: Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin)Active Control9 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Echocardiography

2013

Completed Phase 4