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Ipilimumab for Melanoma

Phase 2
Waitlist Available
Research Sponsored by Robert R. McWilliams, MD
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 1.5 years
Awards & highlights

Study Summary

This trial is testing a combo of 2 drugs to treat patients with a specific type of skin cancer. The drugs will be given in different doses and frequencies over the course of 15 cycles.

Eligible Conditions
  • Mucosal Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 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
Assess Recurrence-free survival time (RFS)
Secondary outcome measures
Assess the Adverse Events
Overall Survival (OS)

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IVExperimental Treatment2 Interventions
Cycles 1-4: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV Day 1 of each Cycle Each Cycle = 21 days Cycles 5-15: Nivolumab IV 480 mg Day 1 of each Cycle Each Cycle = 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Robert R. McWilliams, MDLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,636 Previous Clinical Trials
4,127,528 Total Patients Enrolled
177 Trials studying Melanoma
57,507 Patients Enrolled for Melanoma
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,719 Total Patients Enrolled
1 Trials studying Melanoma
216 Patients Enrolled for Melanoma

Frequently Asked Questions

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

Are there any additional research projects available that assess Ipilimumab?

"Ipilimumab was first examined at Texas Children's Hospital in 2009, and since then 365 studies have been concluded. Currently, there are 765 live trials involving the medication; many of these experiments taking place within Rochester, Minnesota."

Answered by AI

Are there a substantial number of sites performing this clinical examination within the city's boundaries?

"This experiment is being conducted at Mayo Clinic Rochester in Minnesota, Providence Portland Medical Centre in Oregon and Mayo Clinic- Florida located in Jacksonville. There are 4 additional sites that are part of this trial."

Answered by AI

How many individuals are enrolled in this medical experiment?

"This research initiative is no longer soliciting new participants, having been posted on September 12th 2017 and last updated October 25th 2022. If you are searching for alternatives, there exist 754 trials seeking volunteers with melanoma and another 765 studies utilising Ipilimumab recruiting patients at the moment."

Answered by AI

Is the recruitment period for this research project still available?

"As of October 25th 2022, this clinical trial is not actively recruiting participants. It was first posted in September 12th 2017 and last modified on the aforementioned date. Should you seek other trials to join, there are presently 754 studies looking for patients affected by melanoma as well as 765 medical interventions using ipilimumab that need volunteers."

Answered by AI

How is Ipilimumab commonly employed in medical treatments?

"Ipilimumab can be used to treat conditions that were previously unresponsive to anti-angiogenesis therapies, such as malignant neoplasms, inoperable melanoma and squamous cell carcinoma."

Answered by AI

What potential adverse reactions have been observed with Ipilimumab usage?

"There is limited data affirming the safety of ipilimumab, so it obtained a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma
Robert R. McWilliams, MD 2017. "Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03241186.
~5 spots leftby Apr 2025
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