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Checkpoint Inhibitor

Ipilimumab for Melanoma

Phase 2
Waitlist Available
Led By Martin McCarter, MD
Research Sponsored by University of Colorado, Denver
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 2 years from the time of study enrollment for each patient.
Awards & highlights

Study Summary

This trial is testing a new combination treatment for melanoma patients to see if it is safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the time of study enrollment for each patient.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from the time of study enrollment for each patient. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MDSC Frequency
MDSC Suppressive Function
Number of Adverse Events
Secondary outcome measures
Changes in the Frequency of Tumor-specific T Cell Responses
Unresectable Stage III and STAGE IV

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

2Treatment groups
Experimental Treatment
Active Control
Group I: VESANOIDExperimental Treatment2 Interventions
Arm B (VESANOID Therapy) will receive the standard 4 doses of either 3 or 10 mg/kg ipilimumab every three weeks plus the supplemental treatment of 150 mg/m2 of VESANOID orally for 3 days surrounding each dose of ipilimumab (day -1, day 0, day +1) for a total of 12 days of VESANOID treatment.
Group II: IpilimumabActive Control1 Intervention
Arm A (No VESANOIDTherapy) will receive the standard of care treatment with ipilimumab only, receiving the standard 4 doses of either 3 or 10 mg/kg ipilimumab every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tretinoin
FDA approved
Ipilimumab
FDA approved

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,752 Previous Clinical Trials
2,165,589 Total Patients Enrolled
10 Trials studying Melanoma
336 Patients Enrolled for Melanoma
Martin McCarter, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Melanoma
26 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02403778 — Phase 2
Melanoma Research Study Groups: VESANOID, Ipilimumab
Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02403778 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02403778 — Phase 2
~1 spots leftby Jun 2025
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