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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
DEPEND Trial 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.Check my eligibility
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.See study design
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.
DEPEND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My throat cancer has been tested and is not caused by HPV.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
I can provide at least 10 slides for testing or am willing to undergo a new biopsy.
Select...
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.
Select...
I have not had radiation or chemotherapy for head or neck cancer.
DEPEND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Deep Response Rate (DRR)
Secondary outcome measures
Distant control after completing chemoradiation
Locoregional control after completing chemoradiation
Overall Survival rate (OS)
+1 moreOther outcome measures
Acute and late toxicity during treatment
Enteral tube dependency
Functional Assessment of Cancer Therapy scale Head and Neck Quality of life assessments
+3 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Syncope
1%
Pericardial effusion malignant
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Superior vena cava syndrome
1%
Bronchial obstruction
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
DEPEND 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
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Radiation
2003
Completed Phase 3
~1020
5-fluorouracil
2005
Completed Phase 4
~7960
Filgrastim Injection
2018
Completed Phase 1
~10
Cisplatin
2013
Completed Phase 3
~1940
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,008 Previous Clinical Trials
822,214 Total Patients Enrolled
Everett Vokes, MDPrincipal InvestigatorUniversity of Chicago
7 Previous Clinical Trials
315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.My organs are functioning normally.The origin of my cancer is unknown.I have not taken high-dose steroids or immunosuppressants in the last 7 days.My throat cancer has been tested and is not caused by HPV.I do not have any serious health issues that would affect my treatment.I am fully active or can carry out light work.I've had surgery for my cancer that wasn't just a biopsy or to reduce tumor size.I am 18 years old or older.I haven't had major surgery for head or neck cancer in the last 8 weeks.I am willing and able to sign the consent form for this study.My kidney function is good, with a creatinine clearance rate above 45 mL/min.I haven't had any cancer treatment in the last 8 weeks.I have a history of HIV.I can provide at least 10 slides for testing or am willing to undergo a new biopsy.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.I have another cancer, but it's not getting worse or needing treatment, except for certain skin cancers or early cervical cancer.I have an autoimmune disease but haven't needed strong medication for it in the last year.I have not had radiation or chemotherapy for head or neck cancer.I have not received a live vaccine in the last 28 days.I agree to use birth control during and for 6 months after my treatment ends.You are currently taking experimental medications for other studies.I have active Hepatitis B or C, or it has been eradicated.I agree to use birth control during and for 6 months after my treatment ends.I have a history of or currently have non-infectious lung inflammation.You are allergic to nivolumab or any other drugs used in this study.I have an active tuberculosis infection.My cancer is at stage IV, except for a specific type of throat cancer at stage III.
Research Study Groups:
This trial has the following groups:- Group 1: ARM 2
- Group 2: ARM 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What therapeutic conditions is Nivolumab commonly deployed to alleviate?
"Nivolumab is used to treat cases of advanced melanoma which cannot be surgically removed, as well as squamous cell carcinomas, thrombocythemia, essential conditions and those marked by a high risk of relapse."
Answered by AI
Is this medical research currently inviting new participants?
"Yes, the records at clinicaltrials.gov demonstrate that this experiment is actively seeking participants. It was initially published on August 26th 2019 and its content most recently revised on June 3rd 2022."
Answered by AI
How many participants have been enlisted in this research endeavor?
"Affirmative. Clinicaltrials.gov's database reveals that this medical research project, which was initially posted on August 26th 2019 and modified most recently on June 3rd 2022 is actively seeking recruits. Specifically, 36 participants are needed from a single site to complete the trial."
Answered by AI
Has Nivolumab been granted regulatory recognition by the FDA?
"Our assessment of Nivolumab's safety registered a score of 2 as it is currently in Phase 2, with some evidence regarding its safety but no clinical data to support efficacy."
Answered by AI
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