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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

Must not have

Participants who have experienced grade 3 or above skin toxicity from prior EGFR inhibiting therapy

Participants with p16 negative squamous cell carcinoma of unknown primary in cervical lymph node

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had severe skin reactions from previous EGFR therapy.

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My cancer is p16 negative and started in the lymph nodes of my neck.

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I had a severe reaction to previous anti-PD1 therapy.

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My cancer originates from the nasopharynx or salivary glands.

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I have a heart condition.

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My high blood pressure is not under control.

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I have a known infection.

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I have an active HIV, Hepatitis B, or Hepatitis C infection.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Maximum Tolerated Dose

Phase II: Overall Survival (OS)

Secondary study objectives

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%

Hyponatremia

19%

Acne

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Pruritus

15%

Fatigue

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Dizziness

Cough

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

Mouth hemorrhage

Staphylococcal skin infection

Tumor hemorrhage

Electrolyte imbalance

Microcytic anemia

Myocardial infarction

Pneumonitis

Pneumonia

Pulmonary embolism

Respiratory alkalosis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010

Cetuximab

2011

Completed Phase 3