← Back to Search

Checkpoint Inhibitor

Nivolumab for Skin Cancer

Phase 2
Waitlist Available
Led By Melissa Wilson, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a negative sentinel lymph node biopsy or undergo a failed attempt at sentinel lymph node biopsy including lymphoscintigraphy
Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing nivolumab to treat patients with stage IIB-IIC melanoma. Monoclonal antibodies, like nivolumab, may stop tumor cells from growing and spreading.

Who is the study for?
This trial is for patients with stage IIB-IIC melanoma that can be surgically removed. They must have no metastatic disease, acceptable blood counts and organ function, and a good performance status (able to carry out daily activities). HIV-positive individuals may join if they meet certain criteria. Women who can bear children need a negative pregnancy test and must use birth control. Participants cannot have had certain prior treatments or live vaccines recently, nor active hepatitis or autoimmune diseases.Check my eligibility
What is being tested?
The study is testing Nivolumab's effectiveness on early-stage melanoma suitable for surgery. Nivolumab is an antibody that might stop cancer cells from growing by interfering with their signals. The trial will see if this treatment prevents the spread of cancer after the tumor has been surgically removed.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in organs like lungs (pneumonitis), liver, intestines, skin reactions, hormone gland problems (like thyroid issues), kidney injury, infusion reactions during administration of the drug, fatigue and weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My sentinel lymph node biopsy was negative or the attempt to perform one failed.
Select...
I do not have an active hepatitis B or C infection.
Select...
My skin cancer was surgically removed and is classified as stage IIB or IIC.
Select...
My scans show no signs of cancer spread beyond the original site.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Recurrence-free survival
Secondary outcome measures
Incidence of adverse events
Median duration of distant metastases-free survival
Median duration of overall survival

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%
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%
Hypertension
7%
Bronchitis
7%
Chills
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%
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
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: Treatment (nivolumab)Experimental Treatment1 Intervention
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,885 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,006 Total Patients Enrolled
Melissa Wilson, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03405155 — Phase 2
Skin Cancer Research Study Groups: Treatment (nivolumab)
Skin Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03405155 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03405155 — Phase 2

Frequently Asked Questions

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

Are there still vacancies available for those interested in participating in this trial?

"This research is no longer actively enrolling patients, having been first posted on January 17th 2018 and last modified November 29th 2022. However, there are currently 758 studies seeking individuals with malignant melanoma of skin and another 718 trials accepting participants for Nivolumab treatment."

Answered by AI

How many participants have enrolled in this research project?

"This trial is no longer accepting patients. It was posted on the 17th of January 2018 and finalized updates were made on November 29, 2022. If you are seeking alternative clinical trials, there are currently 758 studies for malignant melanoma of skin and another 718 for Nivolumab that actively enrolling participants."

Answered by AI

Does the FDA recognize Nivolumab as a viable treatment option?

"There is limited data suggesting Nivolumab's safety, thus it has been assigned a score of 2. However, as this research is still in its Phase 2 stages and no efficacy evidence has yet to be established."

Answered by AI

What therapeutic applications has Nivolumab been used for?

"Nivolumab is most commonly prescribed to treat cancers, but it can also be used for a range of other medical afflictions such as advanced melanoma and metastatic esophageal adenocarcinoma."

Answered by AI

What other trials have been conducted to explore the efficacy of Nivolumab?

"Nivolumab was initially trialled in 2012 at Local Institution and has since been tested 252 times. At present, there are 718 clinical trials enrolling patients with a large portion of them being conducted within the city limits of Philadelphia, Pennsylvania."

Answered by AI

Does this trial represent a novel approach to clinical research?

"First studied in 2012, Nivolumab was initially developed and sponsored by Ono Pharmaceutical Co. Ltd.. After the Phase 1 & 2 trials were successfully concluded with 659 participants, 718 active studies now span 2354 cities and 49 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery
2018. "Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03405155.
~3 spots leftby Dec 2024
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