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Monoclonal Antibodies

Triple Drug Therapy for Melanoma

Phase 2

Waitlist Available

Led By Jeffrey Weber, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration

Tumor tissue from the resected site of disease must be provided for biomarker analyses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a combination of three drugs to treat melanoma. The drugs will be given for different lengths of time depending on whether the patient is in the induction or maintenance phase of the trial. The trial will assess the safety and tolerability of the combination and the pharmacodynamic activity of one of the drugs.

Who is the study for?

This trial is for adults with advanced melanoma that can't be removed by surgery. Participants must have a good performance status, meaning they're fairly active and able to care for themselves. They should not have had certain previous cancer treatments or serious health conditions like heart failure or uncontrolled disorders. Women who can become pregnant and men with partners of childbearing potential must agree to use contraception.Check my eligibility

What is being tested?

The study tests Tocilizumab combined with Ipilimumab and Nivolumab in patients with stage III or IV melanoma. It's an open-label, single-arm Phase II trial where everyone gets the same treatment: Tocilizumab every 6 weeks for five doses plus four induction doses of the other two drugs until week 12, followed by maintenance Nivolumab alone up to one year.See study design

What are the potential side effects?

Possible side effects include immune system reactions affecting organs, infusion-related symptoms (like fever or chills), fatigue, increased risk of infections due to weakened immunity, liver function changes, skin reactions at injection sites, and potentially others as this combination is still under investigation.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery with general anesthesia over 4 weeks ago.

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I can provide a sample of my tumor tissue for testing.

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I have signed the required consent form for this study.

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My brain metastases have been treated and show no signs of returning for at least 4 weeks.

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I am fully active or have some restrictions but can still care for myself.

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My melanoma is at Stage IIIb/c/d or IV and cannot be removed with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Antitumor activity of tocilizumab administered in combination with ipilimumab and nivolumab

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

Inpatient admission

fatigue

agranulocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Tocilizumab

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Induction Phase, Maintenance PhaseExperimental Treatment3 Interventions

Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the DLT period. Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.

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

Tocilizumab

2012

Completed Phase 4

~1840

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,686 Total Patients Enrolled

11 Trials studying Melanoma

280 Patients Enrolled for Melanoma

Jeffrey Weber, MDPrincipal InvestigatorNew York Langone Health

2 Previous Clinical Trials

14 Total Patients Enrolled

2 Trials studying Melanoma

14 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03999749 — Phase 2

Melanoma Research Study Groups: Induction Phase, Maintenance Phase

Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03999749 — Phase 2

Ipilimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999749 — Phase 2

Frequently Asked Questions

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

Tocilizumab has been used to help patients, but are there any safety concerns that come with this medication?

"Tocilizumab's safety is based on data from Phase 2 clinical trials, which means that while there is evidence that the drug is safe, its efficacy has not been studied."

Answered by AI

Are people still signing up to participate in this clinical trial?

"That is correct, the clinical trial indicated on clinicaltrials.gov is still recruiting patients. This particular study was first posted on 6/11/2019, and the most recent update was made on 3/29/2022. There are 4 locations enrolling a total of 67 participants."

Answered by AI

For what type of patients is Tocilizumab most often prescribed?

"Tocilizumab, while most commonly used to treat unresectable melanoma, can also be useful in treating other cancers like squamous cell carcinoma. Additionally, this medication can help patients who are at a high risk of disease recurrence."

Answered by AI

Does Tocilizumab have a long history of research?

"Tocilizumab was first researched in 2009 by the team at Texas Children's Hospital. As of now, 582 total studies have been completed while 866 are ongoing. A large majority of these latter trials take place in Boston, MA."

Answered by AI

How many participants are being allowed in this research project?

"Yes. The clinical trial's information page on clinicaltrials.gov indicates that it is still recruiting patients. This specific study was originally posted on 6/11/2019, with the most recent edit being made on 3/29/2022. There are 4 sites for this 67-patient study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

2019. "A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999749.

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