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Checkpoint Inhibitor

Ipilimumab +/− Sargramostim for Skin Cancer

Phase 2

Waitlist Available

Led By Frank S Hodi

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

No active infection with hepatitis B

No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks

Must not have

Patients are excluded if they have a history of prior treatment with ipilimumab or prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist

Patients with any history of central nervous system (CNS) metastases are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 2 years, then every 6 months for 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying ipilimumab with or without sargramostim to see how well they work in treating patients with stage III or stage IV melanoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ipilimumab may cause immune-related side effects such as inflammation in various organs, skin rash, diarrhea, and hormone gland problems. Sargramostim can lead to bone pain, fever-like symptoms and injection site reactions.

Eligibility Criteria

Inclusion Criteria

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

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I do not have an active hepatitis B infection.

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

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

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I have had only one treatment for advanced melanoma.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 2 years, then every 6 months for 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months for 2 years, then every 6 months for 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, then every 6 months for 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Progression-free Survival (PFS)

Proportion of Patients With Objective Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

2006

Completed Phase 4

~850

Ipilimumab

2015

Completed Phase 3

~3420