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PD-1 Inhibitor
Biomarker-Guided Immunotherapy Discontinuation for Melanoma
Phase 2
Recruiting
Led By Geoffrey T Gibney
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition
Patient must have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on restaging scans obtained at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if doctors can safely shorten the use of anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.
Who is the study for?
This trial is for adults with unresectable stage IIIB-IV melanoma. Participants must have had a positive response to initial anti-PD-1 therapy, meet specific health criteria (like normal organ function tests), and not be pregnant or breastfeeding. They should not have brain metastases or other conditions that could affect the study's safety or results.Check my eligibility
What is being tested?
The PET-Stop Trial is testing if biomarkers from PET/CT imaging can guide when to safely stop immunotherapy in patients with advanced melanoma. It involves drugs like Pembrolizumab, Ipilimumab, Nivolumab, and patient observation to determine the effectiveness of early discontinuation.See study design
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, skin rash, fatigue, digestive issues like diarrhea or colitis, hormonal gland problems (like thyroid dysfunction), and potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is advanced and cannot be removed by surgery.
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My cancer has not worsened after starting anti-PD-1 therapy according to recent scans.
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My melanoma comes from the skin, acral-lentiginous areas, or mucosal areas, not the eye.
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My cancer was measurable by specific criteria before starting anti-PD-1 therapy.
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I am able to get out of my bed or chair and move around.
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My hepatitis B virus load is undetectable with treatment.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival (EFS) rate (Arm A)
Secondary outcome measures
EFS
Therapeutic procedure
Overall survival
+2 moreOther outcome measures
Tumor Markers
Determine FDG-PET/CT positivity between the local site read and central review
Metabolic response on serial FDG-PET/CT
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care (nivolumab, pembrolizumab, ipilimumab)Experimental Treatment3 Interventions
Patients continue their standard of care anti-PD-1 therapy. Treatment may consist of the following regimens: 1) nivolumab IV over 30 minutes Q2W or Q4W; 2) pembrolizumab IV over 30 minutes Q3W or Q6W; 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (active surveillance)Experimental Treatment1 Intervention
Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance.
Group III: Arm B (nivolumab, pembrolizumab, ipilimumab)Active Control2 Interventions
Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed continue their standard of care anti-PD-1 therapy for 12 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,772 Total Patients Enrolled
9 Trials studying Melanoma
3,384 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,371 Total Patients Enrolled
557 Trials studying Melanoma
193,083 Patients Enrolled for Melanoma
Geoffrey T GibneyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or willing to use effective birth control during and after the study as required.Your platelet count is at least 100,000 per microliter, as measured within the last 4 weeks before joining the study.I do not have cancer that has spread to my brain.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.Your total bilirubin level should be within the normal range, unless you have a history of Gilbert's syndrome, in which case it can be slightly higher.Your liver function tests should be within a certain range, which will be checked within 4 weeks before you join the study.My melanoma is advanced and cannot be removed by surgery.You must either have no signs of cancer on a certain scan after 52 weeks, or if you do have signs of cancer, you must either have had a biopsy to confirm if there is cancer present, or it must not be safe or possible to have a biopsy.My cancer has not worsened after starting anti-PD-1 therapy according to recent scans.I am currently on a standard anti-PD-1 therapy without severe side effects.I had a special scan called FDG-PET/CT around one year after starting my anti-PD-1 therapy.Your white blood cell count is at least 3,000 per microliter within the past 4 weeks before joining the study.My melanoma comes from the skin, acral-lentiginous areas, or mucosal areas, not the eye.Your kidney function test results should show creatinine levels within a certain range.Your white blood cell count is at least 1,500 per microliter.I am not on any cancer treatments other than standard anti-PD-1, but I may be taking medication for bone metastases.I can have a biopsy or have valid reasons for not being able to, and I can pause any blood thinner medication if needed.My cancer was measurable by specific criteria before starting anti-PD-1 therapy.I have another cancer type, but it won't affect this trial's treatment.I am able to get out of my bed or chair and move around.My hepatitis B virus load is undetectable with treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (active surveillance)
- Group 2: Arm B (nivolumab, pembrolizumab, ipilimumab)
- Group 3: Standard of Care (nivolumab, pembrolizumab, ipilimumab)
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.
What is the FDA's take on Patient Observation?
"While there is some data supporting the safety of Patient Observation, it remains unproven whether or not the intervention is actually effective. We've given it a score of 2."
Answered by AI
What other medical research studies have made use of Patient Observation as a data gathering method?
"There are presently 1741 clinical trials studying Patient Observation. Of these, 203 live trials are in Phase 3. The majority of the many trials for Patient Observation are based in Houston, Texas; however, there are 75686 locations running studies for this treatment globally."
Answered by AI
Are patients still being accepted into this research program?
"The website clinicaltrials.gov says that this trial is still looking for patients. It began on 8/27/2020 and the most recent update was on 7/28/2022."
Answered by AI
How many individuals are allowed to be enrolled in this research project?
"A total of 150 participants are required for this study, all of whom must meet the inclusion criteria. Patients can go to Wayne Hospital in Greenville, Ohio or Central Ohio Breast and Endocrine Surgery in Gahanna, Colorado (among other locations) to take part in this trial."
Answered by AI
Why is it common for patients to be observed after taking this medication?
"While it is primarily used as an intervention for those with unresectable melanoma, patient observation can also help treat microsatellite instability high, squamous cell carcinoma, and patients at a high risk of cancer recurrence."
Answered by AI
Could you please specify how many research facilities are conducting this trial?
"There are 100 sites around the nation that are presently conducting this trial. If you enroll, it is important to select a location near you from the list of Greenville, Gahanna, Springfield and other locations to reduce travel time commitments."
Answered by AI
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