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Checkpoint Inhibitor

Nivolumab +/− Ipilimumab for Melanoma

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed stage III (unresectable) or stage IV melanoma
Treatment naïve patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until date of disease progression or the date of subsequent anti-cancer therapy, whichever occurs first (assessed up to february 2015, approximately 20 months)
Awards & highlights

Study Summary

This trial will compare the effectiveness of two immunotherapy drugs, Nivolumab and Ipilimumab, given alone or in combination, to Ipilimumab given alone in patients with advanced melanoma.

Who is the study for?
This trial is for adults with advanced melanoma that hasn't been treated yet. They must have a certain level of fitness (able to carry out daily activities) and measurable disease by scans. Participants need available tumor tissue for testing but can't join if they have active brain cancer spread, eye melanoma, autoimmune diseases, or are on high-dose steroids or other immune-weakening drugs.Check my eligibility
What is being tested?
The study tests Nivolumab alone or combined with Ipilimumab against Ipilimumab alone in patients who haven't had treatment before. It aims to see if these treatments can slow down the cancer's progression and help patients live longer compared to just using Ipilimumab.See study design
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects like inflammation in various organs including the intestines, liver, skin, and lungs; hormone gland problems; fatigue; rash; itching; diarrhea; nausea; weakness and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma is at an advanced stage and cannot be surgically removed.
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I have not received any treatment for my condition.
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My cancer can be measured by scans.
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I can provide a tissue sample from my cancer that cannot be surgically removed or has spread.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until disease progression or death, whichever occurred first (assessed up to february 2015, approximately 20 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until disease progression or death, whichever occurred first (assessed up to february 2015, approximately 20 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
Rate of Overall Survival
Rate of Progression-Free Survival
Secondary outcome measures
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
+8 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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
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%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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
Group I: Arm C: Ipilimumab+Placebo for NivolumabExperimental Treatment2 Interventions
Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends (Placebo matching with Nivolumab is no longer required)
Group II: Arm B: Nivolumab+Ipilimumab+Placebo for NivolumabExperimental Treatment3 Interventions
Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Group III: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for NivolumabExperimental Treatment3 Interventions
Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,125,020 Total Patients Enrolled
177 Trials studying Melanoma
56,270 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01844505 — Phase 3
Melanoma Research Study Groups: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab, Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab, Arm C: Ipilimumab+Placebo for Nivolumab
Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT01844505 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01844505 — Phase 3

Frequently Asked Questions

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

How many research facilities are overseeing this trial?

"There are a total of 100 patients enrolled in this study, with some coming from Local Institution - 0098 in Washington, Local Institution - 0080 in Lutherville, and the California Pacific Medical Center Research Institute in San Francisco. There are 100 other locations participating as well."

Answered by AI

Does Nivolumab have any serious side effects?

"Nivolumab's safety was ranked a 3 by our analysts at Power. This is due to the fact that this is a Phase 3 trial, which means that, in addition to some data supporting efficacy, there are multiple rounds of data supporting safety."

Answered by AI

How many people are expected to sign up for this research project?

"Unfortunately, this specific clinical trial is not recruiting patients right now. Although, it was updated as recently as October 7th, 2022. There are 782 other trials for unresectable or metastatic melanoma and 801 for Nivolumab that are still looking for patients to enroll."

Answered by AI

What are the standard treatments for which Nivolumab is used?

"Nivolumab has been found to be an effective treatment against various conditions, such as malignant neoplasms and unresectable melanoma. It is often used as a form of anti-angiogenic therapy."

Answered by AI

Are there other similar treatments to Nivolumab that have been studied before?

"Out of the 801 ongoing Nivolumab trials, 87 of them are in Phase 3 testing. Although the city of Pittsburgh, Pennsylvania has a significant amount of trials underway, 43516 locations worldwide are running Nivolumab studies."

Answered by AI

Are there any patients currently being sought for this trial?

"Unfortunately, this specific trial is not currently recruiting patients. Although, there are 1583 other active trials that are seeking participants. This trial was originally posted on June 11th, 2013 and was last updated on October 7th, 2022."

Answered by AI
Recent research and studies
~110 spots leftby Mar 2025