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Checkpoint Inhibitor
Nivolumab + Ipilimumab for Melanoma
Phase 2
Waitlist Available
Research Sponsored by Maria Constantinou
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completely resected stage III (lymph node positive) or resected stage IV disease. Patients with stage T4BN0 are also eligible. It is required that patients with stage IIIA disease have > 1mm nodal involvement via pathology assessment of the resected node. All patients must be disease free to be eligible.
Histologically or cytologically proven melanoma. The primary site of melanoma may be cutaneous on other body site such as ocular or anorectal. Documentation required to be sent to BrUOG.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment for up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to see if they are more effective than the standard of care in treating patients with high-risk resected melanoma.
Who is the study for?
Adults over 18 with high-risk melanoma that's been surgically removed can join. They should be healthy enough for treatment (ECOG 0-1), not have had other cancer treatments except surgery or radiation, and must agree to use birth control. People with certain medical conditions, previous immunotherapy, active infections like hepatitis B/C or HIV, pregnant/breastfeeding women, and those with brain metastases cannot participate.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Nivolumab (3mg/kg every 2 weeks) and Ipilimumab (1mg/kg every 6 weeks) as an adjuvant therapy for six months in patients who've had their melanoma surgically removed but are at high risk of it coming back. The goal is to see if this regimen can prevent the cancer from returning better than current standard care.See study design
What are the potential side effects?
Possible side effects include immune-related issues such as inflammation in various organs, skin reactions like rash or itching, gastrointestinal problems like diarrhea or colitis, liver function changes, hormone gland problems which could affect metabolism and mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer was surgically removed, it had spread to my lymph nodes but I am now disease-free.
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My melanoma diagnosis is confirmed by lab tests.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post treatment for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment for up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Progression-free and Survival Overall
Number of Participants With Treatment Related Toxicities
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Bronchitis
7%
Chills
7%
Hypertension
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%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
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: Adjuvant treatmentExperimental Treatment2 Interventions
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Maria ConstantinouLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
1 Trials studying Melanoma
7 Patients Enrolled for Melanoma
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,332 Total Patients Enrolled
4 Trials studying Melanoma
173,266 Patients Enrolled for Melanoma
Rhode Island HospitalOTHER
260 Previous Clinical Trials
66,985 Total Patients Enrolled
2 Trials studying Melanoma
5,685 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with drugs targeting PD-1, PD-L1, or CTLA-4.You are not pregnant or breastfeeding. If you can have children, you need a negative pregnancy test before starting the treatment. If you have not had a period for over a year or had surgery that caused menopause, you do not need a pregnancy test.I am currently undergoing treatment for cancer.I have tested positive for HIV/AIDS.I have had chest pain at rest, new chest pain, or a heart attack in the last 6 months.My cancer was surgically removed, it had spread to my lymph nodes but I am now disease-free.My blood, liver, and kidney functions meet the study's required levels.I have brain metastases or cancer that has spread to my bones or meninges.I am willing and able to follow the study's required procedures.I haven't had any cancer except for certain skin, bladder, prostate, cervix, or breast cancers in the last 2 years.I have an autoimmune disease but it's under control or not expected to worsen without an external trigger.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My melanoma diagnosis is confirmed by lab tests.I have had a transplant using my own or someone else's tissue.I agree to use effective birth control during and up to 2 months after the study.You have a positive test for hepatitis B or C virus, showing that you have an ongoing infection.I've only had surgery or radiation for melanoma, with the last treatment over 3 weeks ago.I am fully active or can carry out light work.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Adjuvant treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Ipilumumab present serious risks for patients?
"While there is some evidence that ipilimumab is safe, it remains unproven whether or not the medication is effective. Consequently, our team rated its safety as a 2."
Answered by AI
Are patients being enrolled in this study at this time?
"Currently, this study is not seeking any more patients. This trial was originally posted on July 1st 2016 and updated February 24th 2022. There are presently 783 trials actively searching for patients with melanoma and 747 trials for Ipilumumab that are enrolling participants."
Answered by AI
Could you provide more information on other scientific research projects that have used Ipilumumab?
"Ipilumumab is being trialed in 747 different ongoing clinical studies, with 82 of those trials currently in Phase 3. Most of these investigations into Ipilumumab's efficacy are happening in Basel, BE; however, there are 40325 total locations worldwide where these tests are taking place."
Answered by AI
How many people total will be participating in this research?
"Unfortunately, this particular study has completed recruitment. The clinical trial was initially posted on July 1st 2016 but was most recently updated on February 24th 2022. There are other studies open for recruitment that might be a better match – 783 trials for patients with melanoma and 747 trials involving Ipilumumab."
Answered by AI
What are the main conditions that Ipilumumab is used to target?
"Ipilumumab is approved for the treatment of malignant neoplasms as well as other diseases such as unresectable melanoma, squamous cell carcinoma of the skin, and metastatic esophageal adenocarcinoma."
Answered by AI
Are there any other similar trials to this one that have been conducted in the past?
"Research into ipilumumab began in 2010 with a initial clinical trial. This first study was small, involving only 127 patients. The sponsor of this initial research was Medarex. After the success of the Phase 1 drug trial, Ipilumumab received approval and today there are 747 active studies taking place across 50 countries and 2347 cities."
Answered by AI
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