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Checkpoint Inhibitor
Nivolumab + Ipilimumab for Melanoma
Phase 2
Waitlist Available
Led By Margaret Callahan,, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed locally advanced or metastatic disease per the treating institution's standard of care of the following tumor types
Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying how well nivolumab works in treating patients with cancer. Researchers also want to find out what effects, good and bad, nivolumab has on patients.
Who is the study for?
Adults with advanced melanoma or bladder cancer who can provide consent, comply with study requirements, have a life expectancy of at least 4 months, and haven't received certain treatments within the last 28 days. Excluded are those with serious medical issues, recent other cancers, immune system suppression needs, known allergies to trial drugs, pregnant or breastfeeding women not using contraception, and individuals with active brain metastases or autoimmune diseases.Check my eligibility
What is being tested?
The trial is examining how tumors in patients respond to Nivolumab alone or combined with Ipilimumab. It aims to identify tumor characteristics that predict whether these treatments will be effective for advanced melanoma or bladder cancer.See study design
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs (like the lungs or intestines), skin rash, hormone gland problems (like thyroid dysfunction), liver inflammation, kidney injury and infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread to other parts of my body.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is advanced and cannot be removed by surgery.
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My cancer can be measured on scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
response rate
Secondary outcome measures
PD-L1 expression
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%
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%
Sepsis
2%
Malignant pleural effusion
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
1Treatment groups
Experimental Treatment
Group I: melanoma and bladder cancer patientsExperimental Treatment2 Interventions
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
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?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,817 Total Patients Enrolled
76 Trials studying Melanoma
15,897 Patients Enrolled for Melanoma
UConn HealthOTHER
211 Previous Clinical Trials
60,540 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,129,983 Total Patients Enrolled
177 Trials studying Melanoma
57,405 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- All my side effects from previous cancer treatments, except hair loss and tiredness, are mild or gone.I have tested positive for HIV/AIDS.I am a male willing to use contraception during and for 31 weeks after treatment.I am willing and able to follow the study's schedule and requirements.You have a positive test for hepatitis B or C indicating infection.I haven't taken steroids or immunosuppressants in the last 14 days.My cancer is advanced or has spread to other parts of my body.I agree to provide a tumor sample before starting the study treatment.I am 18 years old or older.I am allowed to have targeted radiation therapy while on the study drug, if certain conditions are met.I have not taken drugs targeting T cells like anti-PD-1 or anti-CTLA-4.I am using birth control during and for 23 weeks after the study.I am fully active or can carry out light work.My cancer is advanced and cannot be removed by surgery.I have not had any other cancer besides my current one in the last 2 years.My melanoma cannot be removed by surgery and is advanced.I have an active autoimmune disease or symptoms.My cancer can be measured on scans.I have active cancer spread to my brain or its coverings.
Research Study Groups:
This trial has the following groups:- Group 1: melanoma and bladder cancer patients
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.
How many individuals are being accepted into the cohort of this research?
"At the present, this clinical trial is not looking to take on new patients. It was first posted in September 2015 and its last update occurred in May 2022. If you are searching for alternative studies, there are 1094 skin cancer trials recruiting participants as well as 765 Nivolumab investigations requiring volunteers."
Answered by AI
How many venues are facilitating this experiment?
"Memorial Sloan Kettering Monmouth in Middletown, Memorial Sloan Kettering Cancer Center in New york, and Lehigh Valley Health Network in Allentown are three of the five available sites for this clinical trial. The other two locations have yet to be revealed."
Answered by AI
Are participants still being accepted into this research endeavor?
"The trial as listed on clinicaltrials.gov is no longer actively recruiting for participants, with the last update dated at May 9th 2022 and initial posting of September 14 2015. However, there are 1859 other medical studies that continue to search for volunteers."
Answered by AI
What maladies does Nivolumab typically address?
"Nivolumab can provide therapeutic benefits to those who have had unsuccessful anti-angiogenic therapy, been diagnosed with malignant neoplasms, or are suffering from unresectable melanoma."
Answered by AI
Could you elucidate on the previous research associated with Nivolumab?
"Nivolumab was initially explored in 2009 when it was tested at Texas Children's Hospital. Since then, 365 studies have been completed and 765 are still ongoing; many of these trials are conducted within Middletown, New jersey."
Answered by AI
To what extent can Nivolumab be detrimental to patient health?
"Nivolumab's safety has been partially established, so it was assigned a score of 2. No efficacy data is available to support this medication at the moment."
Answered by AI
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