21 Participants Needed

Cemiplimab + Cetuximab for Head and Neck Cancer

KH
Overseen ByKara Hoffman
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug combination Cemiplimab + Cetuximab for head and neck cancer?

Cetuximab, when used with radiotherapy, has been shown to improve survival in patients with advanced squamous cell cancer of the head and neck. It enhances the effects of radiotherapy without increasing the usual side effects, making it a valuable option for patients who cannot undergo standard chemotherapy.12345

Is the combination of Cemiplimab and Cetuximab safe for humans?

Cemiplimab has a safety profile consistent with previous reports, showing no new safety concerns when used in combination with other treatments. Cetuximab can cause skin reactions and other adverse events, but these are known and have been studied in head and neck cancer patients.678910

How is the drug combination of Cemiplimab and Cetuximab unique for head and neck cancer?

The combination of Cemiplimab and Cetuximab is unique because it pairs an immune checkpoint inhibitor (Cemiplimab) with an epidermal growth factor receptor inhibitor (Cetuximab), potentially enhancing the immune system's ability to fight cancer while also targeting specific cancer cell growth pathways. This dual approach may offer a novel treatment option for head and neck cancer compared to traditional therapies.111121314

What is the purpose of this trial?

The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).

Research Team

CC

Christine Chung

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

Adults with head and neck squamous cell carcinoma (HNSCC) that can be surgically removed are eligible for this trial. They must have good performance status, meet lab criteria, provide tumor tissue for testing, agree to birth control if of childbearing potential, and commit to the study schedule. Excluded are those with severe allergies to similar drugs or red meat/tick bite history, HIV/Hepatitis B/C infections, certain heart conditions, active autoimmune diseases or pneumonitis.

Inclusion Criteria

Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related assessments/procedures being conducted
Must be able and willing to comply to the study visit schedule and protocol requirements
I am fully active or have some restrictions but can still carry out light work.
See 5 more

Exclusion Criteria

Patient with a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or if the patient had red meat allergy/tick bite history
Patients with a known history of human immunodeficiency virus (HIV) infection
I am currently being treated for an infection.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive cemiplimab and cetuximab before surgery

4 weeks
4 visits (in-person)

Surgery

Participants undergo surgery for head and neck squamous cell carcinoma

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

  • Cemiplimab
  • Cetuximab
Trial Overview The trial is testing the safety and benefits of combining two drugs—Cemiplimab and Cetuximab—before surgery in patients with HNSCC. It's a Phase II study where participants receive both medications as part of their pre-surgical treatment regimen.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Cetuximab and Cemiplimab TreatmentExperimental Treatment2 Interventions
Cemiplimab: 350 mg IV dose on C1D1 and C2D1 Cetuximab: 400mg/m2 loading dose on C1D1 followed by 250 mg/m2 IV weekly doses on C1D8, C1D15, and C2D1 (total 4 doses including the loading dose).

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

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George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Cetuximab, an antibody targeting the epidermal growth factor receptor (EGFR), shows only modest effectiveness as a standalone treatment for advanced non-small cell lung cancer (NSCLC), with limited benefits when added to chemotherapy based on phase II studies.
However, cetuximab has demonstrated improved survival rates when combined with radiotherapy in head and neck cancer, and ongoing research is exploring its potential benefits in combination with other treatments for locally advanced NSCLC.
Is there a role for cetuximab in non small cell lung cancer?Morgensztern, D., Govindan, R.[2018]
Cetuximab is a promising treatment for patients with recurrent or metastatic squamous cell cancer of the head and neck who have not responded to cisplatin-based chemotherapy, due to its targeted mechanism and ability to work alongside existing treatments.
When used with radiotherapy for advanced cases, cetuximab does not increase the typical toxicity associated with head and neck radiation, making it a safer alternative for patients unable to tolerate standard cisplatin-based chemoradiation.
The role of EGFR-targeting strategies in the treatment of head and neck cancer.Dequanter, D., Shahla, M., Paulus, P., et al.[2021]
In a Phase III trial, adding cetuximab to radiotherapy for locoregionally advanced squamous cell carcinoma of the head and neck significantly improved median locoregional control from 14.9 to 24.4 months and overall survival from 29.3 to 49.0 months.
For patients with platinum-refractory recurrent or metastatic disease, cetuximab combined with platinum/5-fluorouracil showed improved survival, response rates (10-13%), and disease control (46-56%), along with better symptom management compared to platinum/5-fluorouracil alone.
Cetuximab in the treatment of squamous cell carcinoma of the head and neck.Specenier, P., Vermorken, JB.[2019]

References

Is there a role for cetuximab in non small cell lung cancer? [2018]
The role of EGFR-targeting strategies in the treatment of head and neck cancer. [2021]
Cetuximab in the treatment of squamous cell carcinoma of the head and neck. [2019]
Cetuximab in squamous cell head and neck carcinomas. [2020]
Cetuximab with radiotherapy in patients with loco-regionally advanced squamous cell carcinoma of head and neck unsuitable or ineligible for concurrent platinum-based chemo-radiotherapy: Ready for routine clinical practice? [2015]
Adverse events secondary to cetuximab therapy in head & neck cancer therapy and risk factors for serious outcomes. [2022]
Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. [2021]
Cetuximab, paclitaxel, carboplatin, and radiation for head and neck cancer: a toxicity analysis. [2015]
Phase II study of the combination of cetuximab and weekly paclitaxel in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of head and neck. [2022]
[Cetuximab cutaneous adverse drug reactions: a marker of efficacy for metastatic colorectal cancer and head-neck cancer?]. [2015]
Evaluation of Cetuximab in combination with radiotherapy or chemotherapy against advanced squamous cell carcinoma of the head and neck. [2019]
Recent results of cetuximab use in the treatment of squamous cell carcinoma of the head and neck. [2021]
Review of cetuximab in the treatment of squamous cell carcinoma of the head and neck. [2021]
Cetuximab pharmacokinetic/pharmacodynamics relationships in advanced head and neck carcinoma patients. [2021]
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