Triple Drug Therapy for Melanoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byJanice M. Mehnert

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase II, open-label, single arm study. The study will consist of an assessment of the safety and tolerability of tocilizumab administered concurrently at 4 mg/kg every 6 weeks for 5 doses in combination with ipilimumab and nivolumab for four induction doses to week 12, then maintenance nivolumab alone up to one year to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will inform the use of this 3-drug combination for further phase II and/or phase III clinical testing. The trial will include an assessment of the pharmacodynamic activity of tocilizumab administered in combination with ipilimumab and nivolumab.

Research Team

Janice M. Mehnert

Principal Investigator

New York Langone Health

Eligibility Criteria

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.

Inclusion Criteria

I haven't had cancer treatment for metastatic disease, with some exceptions.

I had surgery with general anesthesia over 4 weeks ago.

My cancer's current state is documented by recent exams and scans.

See 13 more

Exclusion Criteria

You have an ongoing autoimmune disease or are suspected to have one.

I don't have a history of heart rhythm problems or need drugs that affect heart rhythm.

I had cancer other than melanoma, was treated successfully over 2 years ago, and don't need more treatment.

See 6 more

Treatment Details

Interventions

Ipilimumab (Monoclonal Antibodies)
Nivolumab (Monoclonal Antibodies)
Tocilizumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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 dose-limiting toxicity (DLT) period. Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.