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Monoclonal Antibodies

Cetuximab + Nivolumab for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Christine H. Chung, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically or cytologically confirmed squamous cell carcinoma of specified areas

Participants must have ECOG performance status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Study Summary

This trial is testing if two anti-cancer therapies are beneficial for Head and Neck Squamous Cell Carcinoma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include skin reactions from Cetuximab and immune-related issues from Nivolumab such as inflammation in organs like lungs or intestines, hormone gland problems, rash, infusion reactions (like fever/chills), fatigue, nausea, itching and muscle pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as squamous cell carcinoma in the specified areas.

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I can take care of myself and am up and about more than half of my waking hours.

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My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.

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My condition worsened after at least one treatment.

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I am 18 years old or older.

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My organs are functioning normally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose

Phase II: Overall Survival (OS)

Secondary outcome measures

Number of Study Treatment Related Adverse Events

Overall Response Rate (ORR)

Progression Free Survival (PFS)

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%

Vomiting

28%

Neutropenia

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

Cough

Dizziness

White Blood Cell Count Decreased

Hypocalcaemia

Dermatitis Acneiform

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Dyspnoea

Neck pain

Oral Pain

Headache

Anaphylactic reaction

Respiratory alkalosis

Microcytic anemia

Pulmonary embolism

Myocardial infarction

Pneumonia

Pneumonitis

Electrolyte imbalance

Mouth hemorrhage

Staphylococcal skin infection

Tumor hemorrhage

Toxic encephalopathy

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase

Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Cetuximab

2011

Completed Phase 3

~2480

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,397 Total Patients Enrolled

James and Esther King Biomedical Research ProgramOTHER

13 Previous Clinical Trials

1,739 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,613 Previous Clinical Trials

3,200,834 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03370276 — Phase 1 & 2

Squamous Cell Cancer Research Study Groups: Phase I - Affiliate Sites Only, Phase I - Moffitt Site Only, Phase II - Affiliate Sites Only, Phase II - Moffitt Site Only

Squamous Cell Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT03370276 — Phase 1 & 2

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03370276 — Phase 1 & 2

Frequently Asked Questions

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

Does this clinical trial currently have any openings for participation?

"From the information stored on clinicaltrials.gov, it is evident that this medical trial has stopped recruiting patients after its most recent update in July 2022. Nevertheless, there are still 3522 other studies actively seeking participants at present."

Answered by AI

What is the current enrollment for this experiment?

"At this moment, no new participants are being accepted for the study. It was initially launched on December 20th 2017 and last updated July 27th 2022. Nevertheless, individuals looking to become part of a cell cancer trial may join one of 2692 active studies or 830 trials associated with Cetuximab therapies."

Answered by AI

For which medical conditions is Cetuximab most often prescribed?

"Cetuximab is regularly prescribed to fight malignancies, as well as unresectable melanoma, squamous cell carcinomas and metastatic esophageal adenocarcinoma."

Answered by AI

Are there any precedential studies that have investigated Cetuximab?

"First tested in 2007 at Royal Bournemouth Hospital, cetuximab has since been administered to 620 participants. Currently there are 830 active trials for the medication, with many of these studies conducted out of Columbus, Ohio."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

T Cell Repertoire in Peripheral Blood as a Potential Biomarker for Predicting Response to Concurrent Cetuximab and Nivolumab in Head and Neck Squamous Cell Carcinoma

Wang, Xuefeng, Jameel Muzaffar, Kedar Kirtane, Feifei Song, Matthew Johnson, Michael J Schell, Jiannong Li, et al.. 2022. “T Cell Repertoire in Peripheral Blood as a Potential Biomarker for Predicting Response to Concurrent Cetuximab and Nivolumab in Head and Neck Squamous Cell Carcinoma”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2022-004512.

clinicaltrials.govStudy

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

2017. "Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03370276.

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