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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

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My sentinel lymph node biopsy was negative or the attempt to perform one failed.

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I do not have an active hepatitis B or C infection.

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My skin cancer was surgically removed and is classified as stage IIB or IIC.

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My scans show no signs of cancer spread beyond the original site.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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%

Hypoalbuminaemia

10%

Muscular weakness

10%

Dry skin

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hyperkalaemia

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Pneumothorax

Atrial flutter

Bone pain

Small intestinal haemorrhage

Femur fracture

Syncope

Hypercalcaemia

Confusional state

Cancer pain

Neoplasm progression

Circulatory collapse

Pericardial effusion malignant

Superior vena cava syndrome

Bronchial obstruction

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met