Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for 2 years, then every 6 months for 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I do not have an active hepatitis B infection.
Select...
I am not currently on treatments like IL2, interferon, chemotherapy, or steroids.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have had only one treatment for advanced melanoma.
Select...
My melanoma diagnosis was confirmed through tissue biopsy, not just a needle test.
Select...
I do not have an active or chronic hepatitis C infection.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Progression-free Survival (PFS)
Proportion of Patients With Objective Response
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
Ipilimumab
2014
Completed Phase 3
~2670
Sargramostim
2008
Completed Phase 4
~710
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,908 Total Patients Enrolled
557 Trials studying Melanoma
192,988 Patients Enrolled for Melanoma
Frank S HodiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
847 Total Patients Enrolled
3 Trials studying Melanoma
847 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active hepatitis B infection.I do not have an autoimmune disease, or if I have thyroid issues, they are stable with treatment.I have never been treated with ipilimumab or drugs targeting CD137 or CTLA-4.Your AST and ALT levels are not more than 2.5 times the upper limit of normal.I do not have any health or mental conditions that could make treatment risky.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 never had cancer spread to my brain or spinal cord.I have had only one treatment for advanced melanoma.Your white blood cell count is at least 2000 cells per microliter within the last 4 weeks before starting the trial.I am not pregnant or breastfeeding and am using effective birth control.Your platelet count is at least 100,000 per microliter of blood, as measured within the last 4 weeks.I have been cancer-free for over 2 years, except for certain skin, bladder, or cervical cancers.Your bilirubin levels must be within a certain range, unless you have Gilbert's syndrome, in which case there is a different limit for bilirubin levels.My melanoma diagnosis was confirmed through tissue biopsy, not just a needle test.Your white blood cell count is above 1500 cells per microliter.I am not on systemic steroids, but I may use inhaled or topical ones.I do not have HIV.I do not have an active or chronic hepatitis C infection.All my cancer sites were checked within the last month and can be measured.Your hemoglobin level is at least 8 grams per deciliter, as measured within the last 4 weeks before the start of the study.I haven't had vaccines for infectious diseases 4 weeks before or after ipilimumab.Your kidney function test must show a level of creatinine that is no more than three times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (ipilimumab)
- Group 2: Arm A (ipilimumab and sargramostim)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To which illnesses is Ipilimumab generally prescribed?
"Ipilimumab is primarily prescribed to treat liver carcinoma, but can also be effective for cases of advanced renal cell carcinoma (ARCC) in patients who have not previously received treatment or are considered at higher risk."
Answered by AI
What other experiments have utilized Ipilimumab in the past?
"Ipilimumab was initially examined in 2001 at the Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, and since then 336 trials have been completed. At present there are 354 ongoing clinical studies, with a significant portion conducted from Coon Rapids, Minnesota."
Answered by AI
Has the FDA authorized Ipilimumab for use in medical treatments?
"With a score of 2, Ipilimumab's safety has been deemed reliable based on the Phase 2 trial data that are available; however, there is currently no evidence supporting its efficacy."
Answered by AI
How many participants is this clinical trial accommodating?
"This trial has finished recruiting and last updated on November 16th 2022. However, for those searching for other clinical trials involving cutaneous melanoma there are 827 registered medical studies looking for participants and 354 that involve Ipilimumab specifically."
Answered by AI
How many sites are facilitating the execution of this research?
"Across the country, 100 patients are currently being recruited for this trial. For example, Mercy Hospital in Coon Rapids, Hennepin County Medical Center in Minneapolis and Cancer Center of Kansas - Winfield in Winfield have all been identified as locations for participation."
Answered by AI
Are there any open slots for participants in this clinical trial currently?
"At this moment, recruitment for this trial is on hiatus. It was first posted in late 2010 and last updated in mid-2022. If you're interested in additional studies, 827 trials are enrolling patients with cutaneous melanoma while 354 have openings for individuals receiving Ipilimumab therapy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger