Ipilimumab +/− Sargramostim for Skin Cancer

Palo Alto (17 mi)

Overseen byFrank S Hodi

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.

Eligibility Criteria

This trial is for adults with advanced melanoma that can't be surgically removed. They must have a certain level of white blood cells, no HIV or hepatitis infections, and be in good physical condition (ECOG 0-1). Women who could get pregnant must use effective birth control. Participants cannot have brain metastases, autoimmune diseases, or a history of certain treatments like ipilimumab.

Inclusion Criteria

I do not have an active hepatitis B infection.

I am not currently on treatments like IL2, interferon, chemotherapy, or steroids.

I am fully active or restricted in physically strenuous activity but can do light work.

I have had only one treatment for advanced melanoma.

My melanoma diagnosis was confirmed through tissue biopsy, not just a needle test.

I do not have an active or chronic hepatitis C infection.

Exclusion Criteria

I have never been treated with ipilimumab or drugs targeting CD137 or CTLA-4.

I have never had cancer spread to my brain or spinal cord.

I am not on systemic steroids, but I may use inhaled or topical ones.

Treatment Details

The study is testing if combining the immune system booster Ipilimumab with Sargramostim (GM-CSF), which helps grow more immune cells, works better than Ipilimumab alone for treating unresectable stage III/IV melanoma. Patients are randomly assigned to one of the two treatment groups.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (ipilimumab and sargramostim)Experimental Treatment2 Interventions

Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

Group II: Arm B (ipilimumab)Active Control1 Intervention

Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: