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Checkpoint Inhibitor
Nivolumab for Oral Leukoplakia
Phase 2
Waitlist Available
Led By Glenn Hanna, 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
ECOG performance status ≤ 2 (Karnofsky ≥60%, see Appendix A)
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing an immunotherapy drug to see if it can treat OPVL, a condition that causes warts in the mouth.
Who is the study for?
Adults with confirmed oral proliferative verrucous leukoplakia can join this trial. They must be willing to provide blood and tissue samples, have a certain level of platelets, white blood cells, liver and kidney function, and not be pregnant or become pregnant during the study. People with significant autoimmune diseases, recent chemotherapy or immunotherapy treatments, HIV/AIDS, uncontrolled illnesses like heart failure or severe infections are excluded.Check my eligibility
What is being tested?
The trial is testing Nivolumab as a potential treatment for oral proliferative verrucous leukoplakia (OPVL). Participants will receive this immunotherapy drug to see if it's safe and effective in treating OPVL.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 issues; hormonal gland problems leading to changes in mood or energy levels; infusion reactions during administration; fatigue; muscle pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
I am a woman who can have children and have tested negative for pregnancy.
Select...
I have been diagnosed with OPVL, with lesions meeting the size or number criteria.
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
Best Overall Response Rate
Secondary outcome measures
Characterize distinct tumor and circulating immunophentoypes (biomarkers in biopsy and blood samples)
Estimate Cancer Free Survival (CFS) from the time of study registration
Estimate Overall Survival (OS) from the time of study registration
+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%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
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: NivolumabExperimental Treatment1 Intervention
Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle
Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
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?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,915 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,467 Total Patients Enrolled
Glenn Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
127 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I am a woman who can still have children, not sterilized, and not in menopause.I had advanced head & neck cancer treated with surgery and possibly radiation or chemotherapy.I have been treated with immunotherapy targeting cancer.I am 18 years old or older.I do not have any serious illnesses that would stop me from following the study's requirements.I have no active cancer except for certain skin cancers, low-risk prostate cancer, or any cancer in remission for 5 years.My kidney function, measured by creatinine or its clearance, is within the normal range.I will use highly effective birth control for 7 months after the last dose if I am sexually active with a woman who can become pregnant.I have an autoimmune condition but am stable, not on high-dose steroids for over 4 weeks.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks and have recovered from any side effects.I am a woman who can have children and have tested negative for pregnancy.I have been diagnosed with OPVL, with lesions meeting the size or number criteria.My smoking history does not affect my eligibility for this study.My organ and bone marrow functions are normal.I agree to use birth control for 5 months after my last treatment dose.I have a lung condition not caused by an infection.I have HIV or an immunodeficiency condition.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab
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 risks have been associated with Nivolumab treatment?
"Due to the evidence of safety provided by this phase 2 trial, Nivolumab was ranked a 2 on our team's scale. However, its efficacy has yet to be clinically established."
Answered by AI
Are there any vacancies for participants in this trial?
"At present, this trial is not actively recruiting participants. The first posting of the study was on December 5th 2018 while the last edit occured on September 19th 2022. In case you are looking for other studies, 8 trials relevant to leukoplakia and oral health as well as 718 tests regarding Nivolumab are currently enrolling patients."
Answered by AI
Could you outline the results of other investigations conducted on Nivolumab?
"Presently, there are 718 active Nivolumab trials. 82 of these clinical studies have entered Phase 3 and span a total of 40280 sites with most being based in Basel, BE."
Answered by AI
Is this investigation unprecedented in its kind?
"Since 2012, when Ono Pharmaceutical Co. Ltd sponsored the very first research trial of Nivolumab involving 659 patients, there has been a flurry of activity in regards to its clinical trials. Currently 718 active studies are taking place across 49 countries and 2355 cities worldwide."
Answered by AI
How many candidates are being accepted for participation in this experiment?
"Unfortunately, this trial is not presently looking for volunteers. It was first listed on December 5th 2018 and recently modified on September 19th 2022. Alternatively, there are 8 studies recruiting patients with leukoplakia in the oral region as well as 718 trials that are seeking Nivolumab candidates."
Answered by AI
To what medical afflictions does Nivolumab provide relief?
"Nivolumab is often prescribed for malignant neoplasms, though it also can be beneficial to those diagnosed with unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
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