Your session is about to expire
← Back to Search
Pre-surgery Immunotherapy for Melanoma
Phase 2
Recruiting
Led By Michael Postow, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Adults at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of two immunotherapy drugs given before surgery to see if it can kill melanoma tumors and prevent the disease from coming back.
Who is the study for?
This trial is for adults over 18 with certain stages of melanoma (IIIB, IIIC, IIID, or IV) that can be removed by surgery. Participants must understand the study and agree to its rules. They should have good physical function and not be pregnant or nursing. People who've had specific immunotherapies or suffer from autoimmune diseases, severe allergies to antibodies, HIV/AIDS, hepatitis B infection, or other conditions making treatment risky are excluded.Check my eligibility
What is being tested?
The trial tests if combining nivolumab and ipilimumab as pre-surgery (neoadjuvant) therapy helps shrink melanoma tumors and prevent their return post-surgery. It also examines a new PET scan technique to see how well the immune system responds to this treatment.See study design
What are the potential side effects?
Nivolumab and Ipilimumab may cause side effects like fatigue, skin reactions, digestive issues (diarrhea), liver inflammation (hepatitis), hormone gland problems (like thyroid disorders), lung inflammation (pneumonitis), kidney inflammation (nephritis), muscle pain/inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
I understand the study requirements and have signed the consent form.
Select...
I am using birth control and my pregnancy test was negative.
Select...
My melanoma is at an advanced stage but can be removed with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major pathologic responses/MPR
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Stage III MelanomaExperimental Treatment4 Interventions
All participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET Scan
2006
Completed Phase 3
~590
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,827 Total Patients Enrolled
76 Trials studying Melanoma
15,950 Patients Enrolled for Melanoma
Michael Postow, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
165 Total Patients Enrolled
5 Trials studying Melanoma
165 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I do not have an active autoimmune disease or need for immunosuppression.I have received immunotherapy targeting CTLA-4 or PD-1/PD-L1 before.My cancer's BRAF status does not affect my eligibility.I have an active hepatitis B infection confirmed by a test.I am 18 years old or older.I haven't taken any experimental drugs within the last 30 days.I understand the study requirements and have signed the consent form.I use a highly effective birth control method.I have health issues that could make treatment risky or affect its side effects.My melanoma is in-transit.I am using birth control and my pregnancy test was negative.I have had my spleen removed or have a spleen disorder.My melanoma is at an advanced stage but can be removed with surgery.I have tested positive for HIV/AIDS.My melanoma might not be removable with surgery.You have had a serious allergic reaction to any monoclonal antibody in the past.The tumor needs to be at least 1cm big and visible on a standard imaging test like a PET or CT scan.Your blood test results need to be within certain ranges for white blood cells, neutrophils, platelets, hemoglobin, creatinine, AST, ALT, and bilirubin.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Stage III Melanoma
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.
How many people will be given the chance to participate in this clinical trial?
"Yes, the study is still recruiting patients. According to the information available on clinicaltrials.gov, this trial was first posted on March 11th, 2020 and was last updated on June 24th, 2020. They are currently looking for 28 participants across 1 site."
Answered by AI
Are people currently signing up for this clinical trial?
"From what is detailed on clinicaltrials.gov, this research is currently looking for participants. The listing was first created on March 11th, 2022 and was edited most recently on June 24th, 2022."
Answered by AI
Is there a high mortality rate associated with Surgical Resection of Melanoma?
"Surgical Resection of Melanoma received a score of 2 because, while there is data supporting its safety, there is currently no evidence that it is an effective treatment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger