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PD-1 Inhibitor

Nivolumab for Lung Cancer Prevention in Smokers

Phase 2
Recruiting
Led By Robert Keith, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤ 1 (Appendix 1)
Participants must be able and willing to undergo three bronchoscopies: before, after four doses of nivolumab (8 weeks), and after 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 weeks through 3 months, then every 3 months through 1 year
Awards & highlights

Study Summary

This trial will test whether the immunotherapy drug nivolumab can improve conditions in the airway of people at high risk for developing lung cancer. The safety of nivolumab will also be monitored.

Who is the study for?
This trial is for adults over 18 who have a history of heavy smoking or past non-small cell lung cancer/head and neck cancer with no active disease for at least a year. They must be able to undergo multiple bronchoscopies, not currently on immune checkpoint inhibitors, without severe heart issues, bleeding disorders, untreated hepatitis B/C, other cancers within the last 5 years (except certain skin/cervical cancers), or life-threatening arrhythmias.Check my eligibility
What is being tested?
The study tests if Nivolumab can improve premalignant bronchial lesions in high-risk individuals due to smoking or previous lung/head and neck cancers. It also assesses the drug's safety. Participants will receive Nivolumab and undergo evaluations including bronchoscopies before treatment, after four doses (8 weeks), and after six months.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid dysfunction), liver issues, kidney problems including nephritis and renal failure; infusion reactions; fatigue; weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I am willing to undergo three bronchoscopies as part of the study.
Select...
You have smoked a lot in your lifetime and have certain lung or head and neck cancer history.
Select...
I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 weeks through 3 months, then every 3 months through 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 weeks through 3 months, then every 3 months through 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in endobronchial histology
Secondary outcome measures
Additional endobronchial histology endpoints using the 2004 WHO classification scale for pre-invasive squamous lesions of the bronchus
Incidence of immune-related adverse events (irAEs)
Other outcome measures
Number of non-synonymous mutations in bronchial dysplastic lesions
Proportion of T lymphocytes in bronchial dysplastic lesions that express PD-1
Proportion of macrophages in bronchial dysplastic lesions that express PD-L1
+2 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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
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%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Superior vena cava syndrome
1%
Syncope
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Cancer pain
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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: Nivolumab Injection [Opdivo]Experimental Treatment1 Intervention
240 mg IV every 2 weeks for 4 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,650 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,626 Total Patients Enrolled
Robert Keith, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
392 Total Patients Enrolled

Media Library

Nivolumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03347838 — Phase 2
Bronchial Dysplasia Research Study Groups: Nivolumab Injection [Opdivo]
Bronchial Dysplasia Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03347838 — Phase 2
Nivolumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03347838 — Phase 2

Frequently Asked Questions

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

Has Nivolumab been cleared by the FDA?

"Nivolumab's Phase 2 status suggests that while there is some evidence of safety, none exists yet for efficacy. Therefore, it received a score of 2 from our team at Power."

Answered by AI

How many test subjects are in this experiment?

"Affirmative, the clinical trial detailed on clinicaltrials.gov is recruiting patients at this time. This particular study was posted on December 6th, 2018 and updated November 4th, 2021. They are looking for 42 individuals total between 2 research sites."

Answered by AI

Are people currently being signed up for this clinical trial?

"That is right. The clinical trial, which was created on December 6th 2018 and last updated November 4th 2021, is open and looking for 42 individuals at 2 sites."

Answered by AI

Does this research project have an age limit for participants?

"As long as they are between 18-80 years old, individuals meet the age requirements for this clinical trial."

Answered by AI

Nivolumab is most commonly given to treat which type of illness?

"While Nivolumab is most often used to fight cancer, it can also be effective in treating other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Is this a new or innovative clinical trial?

"Nivolumab has been under clinical investigation for a decade. The first official study was sponsored by Medarex and took place in 2010 with only 127 participants. After the initial Phase 1 approval, there are now 748 active studies involving nivolumab spanning 2349 cities and 50 countries."

Answered by AI

How can I sign up to participate in this research project?

"This bronchial dysplasia study will allow 42 patients, both male and female, between the ages of 18-80 to participate. Patients must also be willing to comply with all procedures and be available for the entirety of the trial. Lastly, screening bronchoscopy must show endobronchial dysplasia (with a score >4)."

Answered by AI

What other medical research has been conducted with Nivolumab?

"At the moment, 748 studies are ongoing that focus on Nivolumab. Out of those, 82 have reached Phase 3. However, most trials for this treatment Take place in Basel BE with 40405 other locations running related studies."

Answered by AI
~10 spots leftby Dec 2025