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Checkpoint Inhibitor

Ipilimumab for Melanoma

Q: What health conditions is Ipilimumab commonly prescribed to treat?

<p>For the treatment of unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, ipilimumab is a frequent choice. This <a href="https://www.withpower.com/clinical-trials/immunotherapy">immunotherapy</a> has proved to be efficacious in treating keratinization disorders of the feet, dermatologic issues, and benzyl violet conditions as well.</p>

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from the time of study enrollment for each patient.

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

Pain in extremity

Weight decreased

Leukopenia

Alanine aminotransferase increased

Hyponatraemia

Pneumonia

Haemoglobin decreased

Neutrophil count decreased

Dizziness

Malignant neoplasm progression

Aspartate aminotransferase increased

Bone pain

Haemoptysis

Back pain

Headache

Hypomagnesaemia

Stomatitis

Abdominal pain upper

Oedema peripheral

White blood cell count decreased

Chest pain

Dehydration

Abdominal pain

Febrile neutropenia

Paraesthesia

Musculoskeletal pain

Colitis

Death

Lung infection

Pulmonary embolism

Mucosal inflammation

Multi-organ failure

Cerebrovascular accident

Lung neoplasm malignant

Lung abscess

General physical health deterioration

Interstitial lung disease

Liver function test abnormal

Sudden death

Chronic obstructive pulmonary disease

Metastases to central nervous system

Blood creatinine increased

Atrial fibrillation

Cardio-respiratory arrest

Confusional state

Intestinal perforation

Pulmonary haemorrhage

Drug hypersensitivity

Infection

Pneumothorax

Renal failure

Lower respiratory tract infection

Pain

Respiratory failure

Syncope

Hyperglycaemia

Sepsis

Acute kidney injury

Hypersensitivity

Urinary tract infection

Disease progression

Pneumonitis

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,573 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

Frequently Asked Questions

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

Is enrollment for the research project open to individuals over 30 years old?

"Requirements for applicants in this medical trial demand that they are aged between 18 and 89. Additionally, 76 studies have been conducted on those under the age of 18 while 1,072 such trials have been completed with participants over 65 years old."

Answered by AI

Is Ipilimumab a secure treatment for individuals?

"Based on the evidence available, our team at Power gave Ipilimumab a 2 out of 3 rating. This is because while it has some data to suggest safety, there is yet no documentation that confirms its efficacy."

Answered by AI

How many participants are enrolled in the investigation?

"Unfortunately, the trial is not recruiting at present. It was first published on December 17th 2015 and last updated on September 7th 2022. If you are in search of studies to participate in, there currently exists 754 trials for melanoma patients and 337 related to Ipilimumab that actively have open recruitment positions."

Answered by AI

Are there any openings to participate in this exploration?

"Data hosted on clinicaltrials.gov states that this medical trial is no longer actively recruiting patients; it was initially posted in December 2015 and last updated in September 2022. However, a plethora of other studies are currently enrolling participants."

Answered by AI

Has Ipilimumab been evaluated in other clinical experiments?

"Currently, there are 337 clinical trials in operation conducting research on Ipilimumab. Of those experiments, 42 are currently at Phase 3 of the study process. Most trials for this drug take place in Pittsburgh, Pennsylvania; however, 20613 other medical sites across the US also run these studies."

Answered by AI

Is there a way for me to participate in this clinical trial?

"This clinical trial requires 10 volunteers between 18 and 89 years old with an advanced melanoma diagnosis. Furthermore, the participants must be eligible for ipilimumab therapy, able to comprehend a written informed consent document, and willing to have frequent blood tests before and during treatment."

Answered by AI

What health conditions is Ipilimumab commonly prescribed to treat?

"For the treatment of unresectable melanoma, ipilimumab is a frequent choice. This immunotherapy has proved to be efficacious in treating keratinization disorders of the feet, dermatologic issues, and benzyl violet conditions as well."

Answered by AI

Recent research and studies

International ImmunopharmacologyJournal

Targeting Myeloid-derived Suppressor Cells Using All-trans Retinoic Acid in Melanoma Patients Treated with Ipilimumab

Tobin, Richard P., Kimberly R. Jordan, William A. Robinson, Dana Davis, Virginia F. Borges, Rene Gonzalez, Karl D. Lewis, and Martin D. McCarter. 2018. “Targeting Myeloid-derived Suppressor Cells Using All-trans Retinoic Acid in Melanoma Patients Treated with Ipilimumab”. International Immunopharmacology. Elsevier BV. doi:10.1016/j.intimp.2018.08.007.

clinicaltrials.govStudy

Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma

2015. "Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02403778.