Atezolizumab for Throat Cancer

Overseen By Nabil F. Saba, MD, FACP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Immunosuppressants, Immunostimulants, Antivirals, others

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called atezolizumab to evaluate its effectiveness against HPV-related throat cancer that can be surgically removed. Atezolizumab, a type of immunotherapy, helps the immune system fight cancer cells. Participants receive the treatment through an IV, with regular scans and possibly a tumor biopsy. Individuals with HPV-related throat cancer that can be surgically removed might be suitable candidates, particularly if they haven't undergone radiation above the collarbone. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients should not be on certain immunosuppressive medications or systemic immunostimulatory agents before starting the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that atezolizumab is likely to be safe for humans?

Research shows that atezolizumab is generally safe for people with head and neck cancer. In earlier studies, patients who had tried other treatments found it manageable. The most common side effects included fatigue, reduced appetite, and nausea, which were usually mild or moderate.

Atezolizumab has also been used in other cancer studies, suggesting it can be safe for many people. While side effects can occur, they vary from person to person. Patients should always discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for throat cancer, which often involve surgery, radiation, or chemotherapy, Atezolizumab works by boosting the body's immune response. This drug is a type of immunotherapy known as a PD-L1 inhibitor, which helps the immune system recognize and attack cancer cells more effectively. Researchers are excited because Atezolizumab offers a more targeted approach, potentially leading to fewer side effects compared to traditional therapies. Additionally, immunotherapies like Atezolizumab have shown promise in other cancers, raising hopes for better outcomes in throat cancer treatment.

What evidence suggests that atezolizumab might be an effective treatment for throat cancer?

Research has shown that atezolizumab has potential in treating certain cancers, such as non-small-cell lung cancer, where it helped patients live longer. However, in studies involving high-risk head and neck cancers, atezolizumab did not significantly increase survival compared to a placebo. One study found that the 2- and 3-year survival rates with atezolizumab were 82% and 72.3%, respectively. These results are promising but not conclusive. In this trial, researchers are testing atezolizumab for throat cancer linked to HPV because it can help the immune system fight cancer. The treatment alters the immune response to stop tumor growth and possibly prevent cancer from spreading. ^{4 5 6 7 8}

Who Is on the Research Team?

Mihir Patel, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HPV-related oropharyngeal squamous cell carcinoma that can be surgically removed. Participants must not be pregnant, agree to use contraception, and have no extensive neck lymph node involvement. Those with prior radiation above the clavicles or certain other cancers within two years are excluded.

Inclusion Criteria

My throat cancer is caused by HPV and confirmed by tests.

Serum albumin within normal range

I am not pregnant and can become pregnant.

Exclusion Criteria

I have high calcium levels in my blood that are causing symptoms.

My kidney function is below the normal range.

I have a history of lung conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of atezolizumab intravenously, with CT and MRI scans, and possible tumor biopsy

6 weeks

Surgery

Participants undergo surgery after receiving treatment with atezolizumab

2 weeks

Follow-up

Participants are monitored for event-free survival and pathologic response, with biomarker analysis

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab

Trial Overview The study tests Atezolizumab's effectiveness before surgery in patients with resectable HPV-related throat cancer. It examines how this immunotherapy might affect the immune system's response to tumor cells and their ability to spread.

How Is the Trial Designed?

Group I: Treatment (Atezolizumab) Experimental Treatment 4 Interventions

Patients receive atezolizumab IV while on study. Patients undergo CT scan and MRI throughout the study. Patients may undergo tumor biopsy while on study.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.

The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

In a study of 36 patients with advanced hypopharyngeal carcinoma, the addition of nimotuzumab to induction chemotherapy and concurrent chemoradiotherapy significantly improved the objective response rate after treatment, with 91.7% response in the nimotuzumab group compared to 58.3% in the control group.

Patients receiving nimotuzumab also experienced better overall survival (62.5% vs. 51.8%) and longer progression-free survival (23 months vs. 18 months) compared to those who did not receive the drug, with no significant increase in adverse effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nimotuzumab Combined with Induction Chemotherapy and Concurrent Chemoradiotherapy in Unresectable Locally Advanced Hypopharyngeal Carcinoma: A Single Institution Experience in China. Tian, X., Xuan, Y., Wu, R., et al.[2022]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab, an anti-PD-L1 therapy, demonstrated objective response rates of up to 40% in non-small cell lung cancer (NSCLC) and showed similar pharmacokinetics and safety profiles in Chinese patients compared to global studies.

In patients with PD-L1 positive tumors, the combination of atezolizumab with chemotherapy resulted in a significantly higher response rate of 46.2%, indicating enhanced efficacy when used alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab therapy in Chinese patients with locally advanced or metastatic solid tumors: An open-label, phase Ⅰ study]. Zhang, L., Gong, JF., Pan, HM., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab, an inhibitor of PD-L1, was found to be well tolerated in a phase 1-2 trial involving 90 children and young adults with refractory or relapsed solid tumors, with no fatal adverse events reported.

While only 5% of patients achieved an objective response, the study showed comparable serum concentrations of atezolizumab between children and young adults, suggesting potential for future research into optimizing immune checkpoint inhibitors for specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for children and young adults with previously treated solid tumours, non-Hodgkin lymphoma, and Hodgkin lymphoma (iMATRIX): a multicentre phase 1-2 study. Geoerger, B., Zwaan, CM., Marshall, LV., et al.[2020]

In a phase Ia clinical trial involving 32 patients with advanced head and neck cancer, atezolizumab demonstrated a tolerable safety profile, with 66% of patients experiencing treatment-related adverse events, but no grade 5 events reported.

The treatment showed promising efficacy, with 22% of patients achieving objective responses and a median overall survival of 6.0 months, indicating potential benefits regardless of HPV status or PD-L1 expression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Colevas, AD., Bahleda, R., Braiteh, F., et al.[2022]

Atezolizumab, an immune checkpoint inhibitor, has been shown to significantly prolong overall survival in patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy, based on results from the phase II POPLAR and phase III OAK trials.

The treatment is particularly effective in patients with higher PD-L1 expression, demonstrating higher objective response rates, and it has a manageable safety profile with a low incidence of immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer. Blair, HA.[2020]

Atezolizumab (Tecentriq) is an FDA-approved treatment for unresectable or metastatic alveolar soft part sarcoma (ASPS), showing a 24% overall response rate in a clinical trial with 49 patients, and a durable response rate of 67% at 6 months and 42% at 12 months.

The treatment has a manageable safety profile, with common severe side effects including musculoskeletal pain (8%) and hypertension (6%), making it a viable option for patients with limited treatment alternatives for this high-risk disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. Bergsma, EJ., Elgawly, M., Mancuso, D., et al.[2023]

Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40079944/

Atezolizumab in High-Risk Locally Advanced Squamous ... There was no difference in overall survival between atezolizumab and placebo (24-month overall survival, 82.0% vs 79.2%, respectively). No new ...

2. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/tecentriq-imvoke010-trial-head-neck-cancer

Tecentriq Falls Short of Primary Endpoint in IMvoke010 ... Maintenance treatment with Tecentriq (atezolizumab) was not found to produce a significant improvement in event-free survival (EFS) or overall ...

3. targetedonc.com targetedonc.com/view/atezolizumab-falls-short-in-high-risk-hnscc

Atezolizumab Falls Short in High-Risk HNSCC Further assessment of secondary end points demonstrated 2- and 3-year overall survival (OS) rates of 82.0% and 72.3% with atezolizumab; these ...

4. withpower.com withpower.com/trial/phase-2-oropharyngeal-neoplasms-1-2024-d52df

Atezolizumab for Throat Cancer Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival ...

5. nature.com nature.com/articles/s43018-025-00918-1

a multicenter phase 2 trial (EPOC1802) Atezolizumab monotherapy after dCRT resulted in a promising cCR rate, although long-term survival data are required. Similar content being ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30219915/

Safety and clinical activity of atezolizumab in head and ... In this heavily pre-treated advanced HNC cohort, atezolizumab had a tolerable safety profile and encouraging activity, with responses ...

7. tecentriq.global tecentriq.global/home/safety-profile.html

Safety profile - tecentriq Review the safety profile of TECENTRIQ monotherapy and combination therapy in clinical trials, including the most commonly reported adverse reactions.

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)31889-7/fulltext

Safety and clinical activity of atezolizumab in head and ... With an encouraging 1-year overall survival rate of 36%, atezolizumab's efficacy appears to be in the same range as other programmed death-ligand 1/programmed ...