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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

Must not have

Subject who has been treated with immunotherapy. This includes prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants were followed up to 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab, a drug that helps the immune system fight cancer, in patients with OPVL, a condition that can become cancerous. The goal is to see if it can reduce the risk of cancer by shrinking white lesions in the mouth. Nivolumab is a drug approved for treating several cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma.

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.

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.

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 below

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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I am a woman who can have children and have tested negative for pregnancy.

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I have been diagnosed with OPVL, with lesions meeting the size or number criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with immunotherapy targeting cancer.

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I do not have any serious illnesses that would stop me from following the study's requirements.

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I have a lung condition not caused by an infection.

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I have HIV or an immunodeficiency condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants were followed up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants were followed up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants were followed up to 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

Best Overall Response Rate (BORR)

Secondary study objectives

2-year Overall Survival (OS) Rate

COMD QLQ Score Change From Baseline to End of Treatment

Cancer Free Survival at 2 Years (CFS2)

+4 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%

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

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

2015

Completed Phase 3

~4010

0 / 8Eligibility criteria met