← Back to Search

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
Patient must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAID's) known to inhibit platelet function. The use of anti-platelet agents [e.g., dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix)] is allowed only if patient is not receiving concurrent aspirin or NSAID's known to inhibit platelet function
Patient must not have an active autoimmune disease that requires systemic treatment within 2 years prior to randomization. Patients who are receiving replacement therapy for adrenal or pituitary insufficiency will not be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from randomization
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am not on daily aspirin (>325 mg) or NSAIDs that affect blood clotting.
Select...
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
My brain scans show no signs of cancer after treatment for brain metastases.
Select...
My recent kidney function test shows creatinine levels are normal or slightly elevated.
Select...
I have not received any live vaccines in the last 30 days.
Select...
My liver function tests are within the required range.
Select...
I haven't had severe side effects from immune therapy, except manageable ones or stable hormone issues.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I can understand and am willing to sign the consent form, or I have someone who can do it for me.
Select...
I have never had rapid cancer growth after starting immunotherapy.
Select...
I have not had any major bleeding issues or tumors in critical areas.
Select...
I haven't had any major stomach or intestine issues in the last 6 months.
Select...
I am not pregnant or breastfeeding and agree to use birth control during and after the study.
Select...
My bilirubin levels are within the normal range for my condition.
Select...
I haven't taken strong immune-suppressing drugs in the last week, except for low-dose steroids or topical treatments.
Select...
I had platinum/taxanes or cetuximab for cancer and didn't worsen for 4 months.
Select...
I have another cancer type, but it won't affect this trial's treatment.
Select...
My calcium levels are controlled and within normal range.
Select...
I am HIV positive, on treatment, and my viral load is undetectable.
Select...
I don't need frequent procedures to remove excess fluid from my body.
Select...
I haven't had major heart problems or strokes in the last 3 months.
Select...
I don't have any health conditions that would make this treatment unsafe for me.
Select...
I am not on any other cancer treatments and have recovered from any prior radiation.
Select...
I do not have high blood pressure issues or a history of severe blood clot problems.
Select...
My cancer progressed after initial treatment with an immune therapy.
Select...
I haven't had any major surgery or serious injury in the last 28 days and don't expect to need major surgery soon.
Select...
My white blood cell count is healthy for treatment.
Select...
I am 18 years old or older.
Select...
I do not have a history of bleeding disorders.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I've had immunotherapy but no treatments that stop tumors from making new blood vessels.
Select...
I am not on blood thinners for a past clot.
Select...
I haven't had a severe infection or tuberculosis in the last 4 weeks.
Select...
I have never needed high-dose steroids for lung inflammation.
Select...
My cancer shows PD-L1 expression of 1% or more.
Select...
My hemoglobin level is above 9 g/dL.
Select...
My cancer is a specific type of throat or mouth cancer, not related to certain viruses or areas.
Select...
My cancer can be measured by scans taken within the last 4 weeks.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) (Phase III)
Progression free survival (PFS) (Phase II)
Secondary outcome measures
Correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers
Incidence of adverse events (Phase III)
OS in the subset of patients with high PD-L1 expression (Phase III)
+1 more
Other outcome measures
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%
Acne
19%
Hyponatremia
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
9%
Dizziness
9%
Cough
9%
White Blood Cell Count Decreased
7%
Hypochloremia
7%
Hypocalcaemia
7%
Dermatitis Acneiform
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Oral Pain
6%
Neck pain
6%
Dyspnoea
6%
Headache
3%
Anaphylactic reaction
1%
Pulmonary embolism
1%
Pneumonitis
1%
Staphylococcal skin infection
1%
Respiratory alkalosis
1%
Tumor hemorrhage
1%
Electrolyte imbalance
1%
Microcytic anemia
1%
Mouth hemorrhage
1%
Myocardial infarction
1%
Pneumonia
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase

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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Positron Emission Tomography
2008
Completed Phase 2
~2260
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1920
Cetuximab
2011
Completed Phase 3
~2480
Cisplatin
2013
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2790
Docetaxel
1995
Completed Phase 4
~5620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Atezolizumab
2016
Completed Phase 3
~6040
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,926,917 Total Patients Enrolled
Aarti BhatiaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Squamous Cell Carcinoma Research Study Groups: Phase II, Arm C (Bevacizumab, Atezolizumab), Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab), Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab), Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin), Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)
Squamous Cell Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05063552 — Phase 2 & 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063552 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some indications for which Cetuximab is indicated?

"Cetuximab is frequently used to treat non-hodgkin lymphoma but can also be useful in treating metastatic bladder cancer, initial treatment, and recurrent cervical cancer."

Answered by AI

What are some other clinical trials that have utilized Cetuximab?

"Cetuximab was first studied in 1997. In the 24 years since its inception, there have been 3468 completed trials worldwide. Right now, 2060 different cetuximab trials are actively recruiting patients; many of these studies are based out of Dayton, Florida."

Answered by AI

Where can patients sign up for this clinical trial?

"Presently, this study is being conducted in 85 different locations, which include but are not limited to Dayton, Fort Lauderdale and Des Moines. It would be most convenient for you to select the site nearest your location to minimize travel requirements."

Answered by AI

Are we still recruiting people to participate in this research?

"Yes, this clinical trial is recruiting patients as indicated by the most recent updates on clinicaltrials.gov. The study was originally posted on December 16th, 2021 and last updated November 12th, 2022. They are looking for 430 individuals to participate across 85 different locations."

Answered by AI
~287 spots leftby Dec 2027