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Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

A Phase I/II Study of Concurrent Cetuximab and Nivolumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

NCT03370276•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

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.

Detailed Description

PHASE I: Participants will be enrolled sequentially and treated at Dose Level 1, or Dose Level -1, every 2 weeks for 12 cycles or until discontinuation. Each cycle is 4 weeks. Cetuximab is given alone in lead-in period at Day -14 before Cycle 1 only. In all subsequent doses starting Cycle 1 Day 1, nivolumab and cetuximab will be given concurrently. Dose limiting toxicity (DLT) assessment will be performed during Cycle 1 and will start with the initiation of the combination of cetuximab and nivolumab (4 weeks). PHASE II: Once the maximum tolerated dose (MTD) or the recommended phase II dose of cetuximab is determined in Phase I, accrual to the phase II will begin. FOLLOW-UP: Participants will be followed for 2 years from End of Treatment. The imaging studies will be performed every 8 weeks (2 cycles) of the treatments during Cycle 1-6 and then every 12 weeks during Cycle 7-12 as per standard of care. Patient will be followed by treating physicians as per standard of care.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, paranasal sinuses, nasal cavity, hypopharynx, or larynx. Squamous cell carcinoma of unknown primary in cervical lymph node can be included only if p16 status is positive.
•Must have recurrent or metastatic HNSCC stage III/IV that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).Patients with persistent disease following radiation therapy administered with a chemotherapy sensitizer may also be included.
•Must have progressed on at least one prior line of chemotherapy, targeted therapy, palliative radiation, and/or biological therapy regimen for their recurrent and/or metastatic HNSCC. However, if patients are likely to be intolerant to standard first-line systemic chemotherapy, the patients are eligible to enroll to this study as the first-line therapy. Additionally, patients with persistent disease or platinum-refractory recurrent disease may enroll in this study as a first-line therapy.
•Must NOT have any systemic therapy for recurrent and/or metastatic disease except if given as a part of a multimodality treatment (i.e. re-irradiation and systemic therapy for curable intent of locally recurrent disease).
•Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
•Must be ≥ 18 years of age.
•Life expectancy of greater than 3 months.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•Must have normal organ function: Absolute neutrophil count \> 1,500/μL; Hemoglobin \> 9 g/dL; Platelets \> 100,000/μL; Total bilirubin ≤ 1.5 mg/dL X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) \< 3 X institutional ULN (or 5.0 X the ULN in the setting of liver metastasis); Serum creatinine of ≤ 1.5 X ULN or creatinine clearance \> 40 mL/minute (using Cockcroft/Gault formula): Female creatinine clearance = (140 - age in years) x weight in kg x 0.8572 x serum creatinine in mg/ dL; Male creatinine clearance = (140 - age in years) x weight in kg x 1.0072 x serum creatinine in mg/dL.
•Participants, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods). Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
+1 more criteria

Exclusion Criteria

•Have experienced grade 3 or above skin toxicity from prior Epidermal growth factor receptor (EGFR) inhibiting therapy.
•Have experienced grade 3 or above toxicity from prior anti-PD1 therapy.
•Have p16 negative squamous cell carcinoma of unknown primary in cervical lymph node.
•Patients with primary nasopharynx or salivary gland cancers.
•Patients who have had chemotherapy, biological therapy or definitive radiation within 4 weeks of the study enrollment or those who have not recovered from adverse events to ≤ Grade 1 due to agents administered more than 4 weeks earlier.
•Had undergone any major surgery within 4 weeks of study enrollment.
•Had undergone any palliative radiation within 2 weeks of study enrollment.
•Have had other investigational agents within 4 weeks or 5 half-lives, whichever is shorter, of the study enrollment.
•Have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
+7 more criteria

Locations (3)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

The Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

December 20, 2017

Primary Completion Date

September 4, 2021

Completion Date

December 23, 2023

Last Updated

March 10, 2026

Enrollment

ACTUAL participants

Conditions

Squamous Cell Carcinoma of the OropharynxSquamous Cell Carcinoma of the LarynxSquamous Cell Carcinoma of the Oral CavitySquamous Cell Carcinoma of the HypopharynxSquamous Cell Carcinoma of the Paranasal SinusHead and Neck Squamous Cell CarcinomaSquamous Cell CancerHead and Neck Carcinoma

Interventions

Nivolumab

DRUG

Cetuximab

DRUG

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

NCT01473784

Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Mucoepidermoid Carcinoma of the Oral Cavity+49 more

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RECRUITINGPHASE2

Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

NCT04191460

Squamous Cell Carcinoma of the Head and NeckOral Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

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Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab