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Checkpoint Inhibitor

Ipilimumab for Cutaneous Melanoma

Q: What is the extent of participation in this clinical investigation?

This medical study is now closed for patient recruitment. Initial posts were made on July 17th, 2017 and the page was last edited on August 30th 2022. If you are looking to join other trials, there are currently 816 studies recruiting participants with unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> and 765 clinical trials that utilize Ipilimumab seeking enrolment.

Q: What other investigations have been undertaken to explore the efficacy of Ipilimumab?

Since its inception at <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Children's Hospital in 2009, ipilimumab has been tested in 365 clinical trials. Currently, there are 765 live studies of this medication taking place primarily out of Biddeford, <a href="https://www.withpower.com/clinical-trials/maine">Maine</a>.

Q: How many medical facilities are participating in the trial?

A total of 100 medical sites are presently enrolling patients for this clinical trial, with notable locations being Biddeford, Las Vegas and Saint George. To decrease the burden of travelling if you decide to partake in the study, it is advisable to select a centre located close proximity to your residence.

Q: What medical conditions typically warrant the prescribing of Ipilimumab?

Ipilimumab is an effective therapy for individuals with a history of anti-angiogenic treatments, malignant tumours, and inoperable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>.

Q: Is there still availability for enrollees in this research?

At this time, recruitment for the aforementioned trial has been concluded. Initially posted on July 17th 2017, it was last updated on August 30th 2022. For other similar studies presently looking for participants, 816 clinical investigations are open to those with unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> and 765 trials require Ipilimumab patients.

Q: What potential adverse effects should users of Ipilimumab be aware of?

There is limited clinical research regarding the safety of ipilimumab, so it has been given an estimated score of 2.

Phase 2

Waitlist Available

Led By Ari M Vanderwalde

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be >= 18 years of age

Patients must have Zubrod performance status of =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will study how well ipilimumab with or without nivolumab work in treating melanoma. Immunotherapy may help the body's immune system attack the cancer.

Who is the study for?

This trial is for adults with stage IV melanoma or unresectable stage III, excluding those with uveal primary. Participants must have measurable disease, previously treated with anti-PD1 or anti-PD-L1 agents without success, and no systemic therapy within 21 days before joining. They should not be pregnant/nursing and must agree to use contraception.Check my eligibility

What is being tested?

The study compares the effectiveness of two immunotherapy drugs: Ipilimumab alone versus a combination of Ipilimumab and Nivolumab in treating advanced melanoma. It aims to see how these treatments help the immune system fight cancer.See study design

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in organs like the intestines (colitis) or lungs (pneumonitis), fatigue, skin issues, hormone gland problems (like thyroid dysfunction), and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Progression Free Survival

Secondary outcome measures

Change in CD8+ Expression

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Objective Response Rate

+1 more

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

Lung neoplasm malignant

Multi-organ failure

Cerebrovascular accident

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: Arm II (nivolumab, ipilimumab)Experimental Treatment2 Interventions

Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ipilimumab)Active Control1 Intervention

Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,059 Total Patients Enrolled

4 Trials studying Cutaneous Melanoma

198 Patients Enrolled for Cutaneous Melanoma

Ari M VanderwaldePrincipal InvestigatorSWOG Cancer Research Network

Frequently Asked Questions

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

What is the extent of participation in this clinical investigation?

"This medical study is now closed for patient recruitment. Initial posts were made on July 17th, 2017 and the page was last edited on August 30th 2022. If you are looking to join other trials, there are currently 816 studies recruiting participants with unresectable melanoma and 765 clinical trials that utilize Ipilimumab seeking enrolment."

Answered by AI

What other investigations have been undertaken to explore the efficacy of Ipilimumab?

"Since its inception at Texas Children's Hospital in 2009, ipilimumab has been tested in 365 clinical trials. Currently, there are 765 live studies of this medication taking place primarily out of Biddeford, Maine."

Answered by AI

How many medical facilities are participating in the trial?

"A total of 100 medical sites are presently enrolling patients for this clinical trial, with notable locations being Biddeford, Las Vegas and Saint George. To decrease the burden of travelling if you decide to partake in the study, it is advisable to select a centre located close proximity to your residence."

Answered by AI

What medical conditions typically warrant the prescribing of Ipilimumab?

"Ipilimumab is an effective therapy for individuals with a history of anti-angiogenic treatments, malignant tumours, and inoperable melanoma."

Answered by AI

Is there still availability for enrollees in this research?

"At this time, recruitment for the aforementioned trial has been concluded. Initially posted on July 17th 2017, it was last updated on August 30th 2022. For other similar studies presently looking for participants, 816 clinical investigations are open to those with unresectable melanoma and 765 trials require Ipilimumab patients."

Answered by AI