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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other 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
~2610
Nivolumab
2014
Completed Phase 3
~4740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for melanoma, particularly advanced stages, include immune checkpoint inhibitors such as anti-PD-1 therapies (e.g., pembrolizumab, nivolumab). These therapies work by blocking the programmed cell death protein 1 (PD-1) pathway, which tumors exploit to evade the immune system. By inhibiting PD-1, these drugs enhance the body's immune response against melanoma cells. This mechanism is crucial for melanoma patients as it can lead to durable responses and improved survival rates. The trial on biomarker-guided early discontinuation of anti-PD-1 therapy aims to optimize treatment duration, potentially reducing side effects and healthcare costs while maintaining efficacy.

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
13,743 Previous Clinical Trials
40,957,710 Total Patients Enrolled
559 Trials studying Melanoma
195,292 Patients Enrolled for Melanoma
Geoffrey T GibneyPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Nivolumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04462406 — Phase 2
Melanoma Research Study Groups: Arm A (active surveillance), Arm B (nivolumab, pembrolizumab, ipilimumab), Standard of Care (nivolumab, pembrolizumab, ipilimumab)
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04462406 — Phase 2
Nivolumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04462406 — Phase 2
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