← Back to Search

Alkylating agents

Chemoradiotherapy + Nivolumab for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Robert Haddad, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease was assessed following the completion of 2-3 cycles of induction tpn, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (pd). participants were followed up to 18.9 months.
Awards & highlights

Study Summary

This trial is testing a new chemotherapy treatment for people with head and neck cancer who have not had chemotherapy before.

Who is the study for?
Adults with advanced laryngeal or hypopharyngeal cancer, HPV negative, who haven't had chemotherapy or radiotherapy for head and neck cancer. They must have adequate organ function, provide tissue samples, and agree to contraception if of childbearing potential. Excludes those with prior immunotherapy, severe autoimmune conditions not stable on hormones, uncontrolled illnesses, HIV/Hepatitis B/C infections.Check my eligibility
What is being tested?
The trial is testing a combination of treatments: TPN (Total Parenteral Nutrition), Nivolumab (an immunotherapy drug), along with radiation therapy compared to the standard treatment which may include Cisplatin and Docetaxel (chemotherapy drugs) in patients with locoregionally advanced cancers of the throat.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in organs; infusion reactions; fatigue; nausea; blood cell count changes leading to increased infection risk; potential liver or kidney issues due to medication toxicity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease was assessed following the completion of 2-3 cycles of induction tpn, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (pd). participants were observed for ledfs up to 18.9 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease was assessed following the completion of 2-3 cycles of induction tpn, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (pd). participants were observed for ledfs up to 18.9 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
Median Laryngectomy-free Survival (LFS)
Secondary outcome measures
Best Radiologic Response
EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab
EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab
+3 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
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%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) then Radioimmunotherapy (IMRT+N) then adjuvant NExperimental Treatment4 Interventions
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1. Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses). Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-modulated radiotherapy
2010
Completed Phase 2
~220
Nivolumab
2014
Completed Phase 3
~4750
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,508 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,866 Total Patients Enrolled
Robert Haddad, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
1,199 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03894891 — Phase 2
Head and Neck Cancers Research Study Groups: Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) then Radioimmunotherapy (IMRT+N) then adjuvant N
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03894891 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03894891 — Phase 2

Frequently Asked Questions

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

What are the primary indications for Nivolumab?

"Nivolumab is often used as a treatment for advanced directives, but it can also improve outcomes for patients with small cell lung cancer (sclc), testicular cancer, and other malignant neoplasms."

Answered by AI

Is this trial available in different states?

"presently, this trial is enrolling patients at four distinct locations. The sites are situated in Atlanta, Saint Louis, New york with the remaining clinical centres located elsewhere. By selecting the site closest to you, individuals can minimize travel requirements."

Answered by AI

Did Nivolumab go through the FDA's regulatory process?

"Nivolumab's safety was estimated to be a 2 because, while there is data supporting its safety, Phase 2 trials don't have evidence of efficacy."

Answered by AI

What other drugs has Nivolumab been tested with in the past?

"Nivolumab was first studied in 1997 at City of Hope Comprehensive Cancer Center. So far, there have been a total of 1841 completed trials worldwide. Currently, 1662 different clinical trials are still ongoing; many of these taking place in Atlanta, Georgia."

Answered by AI

Are there any available spots for enrolment in this clinical trial?

"This research is no longer recruiting participants. The trial was initially posted on June 11th, 2019 but has not been updated since May 9th, 2022. If you are looking for similar studies, 508 trials for patients with head neoplasms and 1662 trials for Nivolumab are still enrolling individuals."

Answered by AI

How many people are being chosen to participate in this research?

"Unfortunately, this study is not currently taking applications for participation. However, there are 508 other trials concerning head neoplasms and 1662 studies involving Nivolumab that are actively recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
Robert Haddad, MD 2019. "Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03894891.
~1 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top