← Back to Search

Checkpoint Inhibitor

Nivolumab for Melanoma

Phase 2
Recruiting
Led By Alexander N Shoushtari
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether a combination of two different drugs may help patients with mucosal melanoma.

Who is the study for?
Adults who've had surgery for mucosal melanoma without distant metastases can join. They must have certain types of primary lesions or lymph node involvement, no recent heart issues, infections, or other cancers needing treatment. Pregnant/nursing women and those with severe liver disease, autoimmune conditions on steroids, untreated spinal cord compression, bleeding disorders or active infections are excluded.Check my eligibility
What is being tested?
The trial is testing if nivolumab combined with cabozantinib prevents mucosal melanoma from returning after surgery. Nivolumab boosts the immune system to fight cancer while cabozantinib blocks enzymes that help tumor cells grow.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, diarrhea, mouth sores and hand-foot syndrome (redness and pain in hands/feet). Liver problems might occur due to cabozantinib's effect on proteins involved in cell growth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 (RFS)
Secondary outcome measures
Duration of response (Arm 3)
Incidence of adverse events
Overall response rate (Arm 3)
+3 more

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%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
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%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
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

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3 (nivolumab, cabozantinib)Experimental Treatment7 Interventions
Patients receive nivolumab IV over 30 minutes and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 26 cycle in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial.
Group II: Arm 1 (nivolumab, cabozantinib)Experimental Treatment7 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial.
Group III: Arm 2 (nivolumab, placebo)Active Control7 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 and placebo PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Nivolumab
2014
Completed Phase 3
~4750
Biospecimen Collection
2004
Completed Phase 2
~1700
Cabozantinib S-malate
2013
Completed Phase 2
~470

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,755 Total Patients Enrolled
557 Trials studying Melanoma
193,091 Patients Enrolled for Melanoma
Alexander N ShoushtariPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Melanoma
40 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05111574 — Phase 2
Melanoma Research Study Groups: Arm 3 (nivolumab, cabozantinib), Arm 2 (nivolumab, placebo), Arm 1 (nivolumab, cabozantinib)
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05111574 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111574 — Phase 2

Frequently Asked Questions

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

In what medical scenarios is Nivolumab employed?

"Nivolumab can be deployed to treat highly malignant neoplasms, intractable melanoma and squamous cell carcinoma."

Answered by AI

What adverse effects have been associated with Nivolumab treatments?

"Nivolumab is assessed as a 2 on our team's safety scale, since this Phase 2 trial has evidence supporting its security but not yet any data demonstrating efficacy."

Answered by AI

What is the highest possible number of people who may partake in this medical experiment?

"To complete this medical trial, 99 participants need to be recruited who fit the qualification criteria. Recruitment will take place at Saint Vincent Hospital Cancer Center Green Bay in Green Bay, Wisconsin and Saint Vincent Hospital Cancer Center at Saint Mary's in Oconto Falls, Illinois."

Answered by AI

At what number of venues is this experiment in progress?

"Patients from Saint Vincent Hospital Cancer Center Green Bay, Saint Vincent Hospital Cancer Center at Saint Mary's in Oconto Falls and many other locations are currently eligible for enrollment into this trial."

Answered by AI

Is the enrollment for this research still open to participants?

"The information provided on clinicaltrials.gov indicates that this experiment is still in the recruitment stage; it was initially posted on June 1st 2022 and its details were most recently updated on November 18th 2022."

Answered by AI

Is this the inaugural implementation of a trial such as this?

"Currently, there are 794 active trials for Nivolumab in 53 countries and 2553 cities. This immunotherapy drug was first tested by Exelixis back in 2012 with a Phase 2 study that included 86 participants. Since then, 318 more clinical studies have been completed."

Answered by AI

Are there any historical precedents of trials utilizing Nivolumab?

"Nivolumab was first tested in a clinical context at Memorial Sloan Kettering Commack back in 2012. To date, there are 318 concluded trials and an additional 794 ongoing studies being conducted across the United States, notably Green Bay, Wisconsin."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
2022. "Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05111574.
~25 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