Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial (NCT04462406)

🧪 Interventions in This Study

• Ipilimumab (BIOLOGICAL)
• Nivolumab (BIOLOGICAL)
• Pembrolizumab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. STEP 0 PRE-REGISTRATION INCLUSION CRITERIA
2. Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition
3. Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site
4. Patient must have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy
5. Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. Permitted systemic anti-PD-1 therapy regimens include:
6. Nivolumab 240 mg IV every (Q)2weeks or 480 mg IV Q4weeks
7. Pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks
8. Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance
9. Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance
10. Pembrolizumab 2 mg/kg (or 200 mg flat dose) plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks maintenance
11. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
12. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with detectable viral loads are excluded as it is unclear if these patients have a low risk of melanoma progression off anti-PD-1 treatment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (482 Sites)

Showing the first 25 of 482 sites.

• Thomas Hospital — Fairhope, Alabama
• Mobile Infirmary Medical Center — Mobile, Alabama
• Fairbanks Memorial Hospital — Fairbanks, Alaska
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
• CARTI Cancer Center — Little Rock, Arkansas
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
• Mercy Cancer Center - Carmichael — Carmichael, California
• Mercy San Juan Medical Center — Carmichael, California
• Kaiser Permanente Dublin — Dublin, California
• Mercy Cancer Center - Elk Grove — Elk Grove, California
• Kaiser Permanente-Fremont — Fremont, California
• Fresno Cancer Center — Fresno, California
• Kaiser Permanente-Fresno — Fresno, California
• The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California
• Cedars Sinai Medical Center — Los Angeles, California
• Mercy Cancer Center — Merced, California
• Kaiser Permanente-Modesto — Modesto, California
• Kaiser Permanente Oakland-Broadway — Oakland, California
• Kaiser Permanente-Oakland — Oakland, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Melanoma

• Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors — St Louis, Missouri
• FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma — Charlottesville, Virginia
• Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) — Phoenix, Arizona
• Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery — Birmingham, Alabama
• Naltrexone and Propranolol Combined With Immunotherapy — New Brunswick, New Jersey

Explore by condition: All Advanced Melanoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.