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Alkylating agents

Nivolumab + Chemotherapy for Head and Neck Cancer (DEPEND Trial)

Phase 2
Recruiting
Led By Everett Vokes, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
Eastern Cooperative Oncology Group performance status 0-1
Must not have
Unequivocal demonstration of distant metastatic disease (M1 disease).
Unidentifiable primary site.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if adding nivolumab to carboplatin & paclitaxel chemotherapy can help patients with HPV-negative cancer.

Who is the study for?
Adults with advanced stage IV HPV-negative head and neck cancer, who haven't had chemotherapy or radiation for this condition. They must have a good performance status, normal organ function, no history of severe allergies to the drugs used in the trial, not be pregnant or breastfeeding, and agree to use contraception.
What is being tested?
The study is testing if nivolumab combined with carboplatin and paclitaxel can shrink cancers significantly in patients with advanced HPV-negative head and neck cancer before they receive other treatments like surgery or more chemo.
What are the potential side effects?
Possible side effects include immune-related reactions that may affect organs, fatigue from chemotherapy agents like carboplatin and paclitaxel, blood cell count changes due to filgrastim injections, digestive issues from hydroxyurea pills or cisplatin treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My throat cancer has been tested and is not caused by HPV.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I can provide at least 10 slides for testing or am willing to undergo a new biopsy.
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My cancer is a type of head and neck cancer that has not spread to other parts of my body and is not caused by HPV.
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I have not had radiation or chemotherapy for head or neck cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to distant parts of my body.
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The origin of my cancer is unknown.
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I have not taken high-dose steroids or immunosuppressants in the last 7 days.
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I've had surgery for my cancer that wasn't just a biopsy or to reduce tumor size.
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I have a history of HIV.
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I have an autoimmune disease but haven't needed strong medication for it in the last year.
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I have a history of or currently have non-infectious lung inflammation.
Select...
I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Deep Response Rate (DRR)
Secondary study objectives
Distant control after completing chemoradiation
Locoregional control after completing chemoradiation
Overall Survival rate (OS)
+1 more
Other study objectives
Acute and late toxicity during treatment
Enteral tube dependency
Functional Assessment of Cancer Therapy scale Head and Neck Quality of life assessments
+3 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ARM 2Experimental Treatment6 Interventions
Radiation therapy with chemotherapy
Group II: ARM 1Experimental Treatment3 Interventions
Induction Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5450
Radiation
2003
Completed Phase 2
~780
5-fluorouracil
2005
Completed Phase 4
~8440
Filgrastim Injection
2018
Completed Phase 1
~10
Cisplatin
2013
Completed Phase 3
~3120
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,873 Total Patients Enrolled
Everett Vokes, MDPrincipal InvestigatorUniversity of Chicago
7 Previous Clinical Trials
315 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03944915 — Phase 2
Squamous Cell Carcinoma Research Study Groups: ARM 2, ARM 1
Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03944915 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03944915 — Phase 2
~4 spots leftby Jul 2025
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