95 Participants Needed

Cetuximab + Nivolumab for Head and Neck Cancer

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, biological therapy, or radiation within 4 weeks before joining the study, and you must not be on certain immunosuppressive medications within 14 days of starting the trial.

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

Cetuximab has been approved for use in combination with chemoradiation therapy for locally advanced head and neck squamous cell carcinoma since 2006, indicating its effectiveness in this context.12345

Is the combination of Cetuximab and Nivolumab safe for humans?

Cetuximab is generally considered safe and well-tolerated, with common side effects being skin-related issues like rashes. It has been used in treating various cancers, including head and neck cancer, with these side effects usually being mild.16789

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

The combination of Cetuximab and Nivolumab is unique because Cetuximab targets the epidermal growth factor receptor (EGFR), which is important in cancer growth, while Nivolumab is an immune checkpoint inhibitor that helps the immune system attack cancer cells. This dual approach may offer a novel way to improve treatment outcomes compared to traditional therapies.15101112

What is the purpose of this trial?

The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.

Research Team

CH

Christine H. Chung, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

Adults with advanced Head and Neck Squamous Cell Carcinoma (HNSCC) who have already tried at least one treatment like chemotherapy or radiation. They must be in good enough health to participate, not pregnant, and using effective contraception if sexually active. People can't join if they've had certain recent treatments, uncontrolled illnesses, severe allergies to similar drugs, or specific heart conditions.

Inclusion Criteria

Participants must have a life expectancy of greater than 3 months
My cancer is confirmed as squamous cell carcinoma in the specified areas.
Participants, if sexually active, must meet contraceptive requirements
See 6 more

Exclusion Criteria

I had severe skin reactions from previous EGFR therapy.
My cancer is p16 negative and started in the lymph nodes of my neck.
I had a severe reaction to previous anti-PD1 therapy.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive cetuximab and nivolumab every 2 weeks for 12 cycles or until discontinuation. Dose limiting toxicity assessment during Cycle 1.

48 weeks
12 visits (in-person)

Phase II Treatment

Participants receive cetuximab and nivolumab at the recommended Phase II dose.

48 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Imaging studies every 8 weeks during Cycle 1-6 and every 12 weeks during Cycle 7-12.

24 months

Treatment Details

Interventions

  • Cetuximab
  • Nivolumab
Trial Overview The trial is testing the effectiveness of combining two FDA-approved cancer drugs—Cetuximab and Nivolumab—in treating HNSCC. Researchers want to see if this drug duo works better together for patients whose cancer has returned or spread and cannot be cured with surgery or radiation alone.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Phase II - Moffitt Site OnlyExperimental Treatment2 Interventions
Nivolumab and Cetuximab at recommended Phase II dose (RP2D).
Group II: Phase II - Affiliate Sites OnlyExperimental Treatment2 Interventions
Nivolumab and Cetuximab at recommended Phase II dose (RP2D).
Group III: Phase I - Moffitt Site OnlyExperimental Treatment2 Interventions
Nivolumab and dose escalation of Cetuximab. Dose Level 1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Dose Level -1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 250 mg/m\^2; Nivolumab 240 mg.
Group IV: Phase I - Affiliate Sites OnlyExperimental Treatment2 Interventions
Nivolumab and dose escalation of Cetuximab. Dose Level 1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Dose Level -1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 250 mg/m\^2; Nivolumab 240 mg.

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

🇺🇸
Approved in United States as Erbitux for:
  • Locally or regionally advanced squamous cell carcinoma of the head and neck
  • Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
  • K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
  • BRAF V600E mutation-positive metastatic colorectal cancer
🇪🇺
Approved in European Union as Erbitux for:
  • Squamous cell carcinoma of the head and neck
  • K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer

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+

James and Esther King Biomedical Research Program

Collaborator

Trials
15
Recruited
2,200+

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

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor, which plays a crucial role in the growth of various cancers.
It received accelerated approval from the US FDA in February 2004 for treating metastatic colorectal cancer based on positive tumor response rates observed in Phase II clinical trials.
Cetuximab.Goldberg, RM.[2020]
The use of chemoradiation therapy (CRT) for locally advanced head and neck squamous cell carcinoma (HNSCC) significantly increased from 29% in 2001 to 61% in 2009, indicating a growing acceptance of this treatment approach.
Since the approval of cetuximab in 2006, it has become the most commonly used agent in CRT, suggesting that it may have contributed to the increased use of CRT, particularly among older and sicker patients.
Trends in chemoradiation use in elderly patients with head and neck cancer: Changing treatment patterns with cetuximab.Baxi, SS., O'Neill, C., Sherman, EJ., et al.[2022]
The ERBITAX regimen (paclitaxel and cetuximab) demonstrated a response rate of 37.7% in 531 patients with recurrent/metastatic squamous cell carcinoma of the head and neck who were ineligible for cisplatin-based chemotherapy, indicating its efficacy as a first-line treatment.
Patients who received immunotherapy after ERBITAX treatment had significantly improved overall survival (OS) of 29.8 months compared to 13.8 months for those receiving other treatments, suggesting a beneficial sequential treatment strategy.
TTCC-2019-02: real-world evidence of first-line cetuximab plus paclitaxel in recurrent or metastatic squamous cell carcinoma of the head and neck.Rubió-Casadevall, J., Cirauqui Cirauqui, B., Martinez Trufero, J., et al.[2023]

References

Cetuximab. [2020]
Trends in chemoradiation use in elderly patients with head and neck cancer: Changing treatment patterns with cetuximab. [2022]
TTCC-2019-02: real-world evidence of first-line cetuximab plus paclitaxel in recurrent or metastatic squamous cell carcinoma of the head and neck. [2023]
Investigational EGFR-targeted therapy in head and neck squamous cell carcinoma. [2021]
YAP1 is a potential biomarker for cetuximab resistance in head and neck cancer. [2021]
A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer. [2022]
Grade 3/4 dermatitis in head and neck cancer patients treated with concurrent cetuximab and IMRT. [2015]
[The efficacy of cetuximab for metastatic colorectal cancer]. [2018]
Complications after oesophagectomy with possible contribution of neoadjuvant therapy including an EGFR-antibody to a fatal outcome. [2021]
[Monoclonal antibodies for the treatment of head and neck cancer]. [2018]
The role of cetuximab in the management of head and neck cancers. [2020]
Evaluation of Cetuximab in combination with radiotherapy or chemotherapy against advanced squamous cell carcinoma of the head and neck. [2019]
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