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Checkpoint Inhibitor

Nivolumab for Premalignant Lesion

Phase 2
Waitlist Available
Led By Moran Amit, MD, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity.
2. Be willing and able to provide written informed consent for the trial. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC "Policy For Consenting Non-English Speaking Participants."
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions

Who is the study for?
This trial is for individuals with high-risk oral premalignant lesions, which are early signs that may lead to cancer. Specific eligibility criteria details are not provided.
What is being tested?
The study tests the effectiveness of nivolumab, an immunotherapy drug, administered directly into the lesion in the mouth to see if it can prevent these early signs from developing into cancer.
What are the potential side effects?
While specific side effects for this trial aren't listed, nivolumab generally can cause immune-related reactions affecting various organs, fatigue, skin issues, and flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and AdverseEevents (AEs)

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%
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%
Chest pain
10%
Muscular weakness
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Abdominal pain upper
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Hyperkalaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Pain
5%
Malaise
5%
Dry mouth
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Malignant pleural effusion
2%
Adrenal insufficiency
2%
Embolism
2%
Atrial fibrillation
2%
Cardiac failure
2%
General physical health deterioration
2%
Sepsis
1%
Pericardial effusion
1%
Small intestinal obstruction
1%
Cancer pain
1%
Confusional state
1%
Gastrointestinal haemorrhage
1%
Bronchial obstruction
1%
Ileus
1%
Small intestinal haemorrhage
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Lung cancer metastatic
1%
Syncope
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Pancytopenia
1%
Atrial flutter
1%
Colitis
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Pneumothorax
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/PlaceboExperimental Treatment1 Intervention
Participants will be screened for LOH and randomly assigned to trial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,202 Total Patients Enrolled
3 Trials studying Premalignant Lesion
452 Patients Enrolled for Premalignant Lesion
Moran Amit, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
~30 spots leftby May 2027
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