A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.

NCT07830225 | Recruiting

• 2 other identifiers: 092602Pro2026001627
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II pilot study evaluating the use of circulating tumor DNA (ctDNA) to guide the optimal duration of standard of care immune checkpoint inhibitor (ICI) therapy in patients with unresectable and/or metastatic melanoma who have radiographic evidence of disease control and/or response to treatment.

Conditions

Melanoma (Skin Cancer)

Keywords

Advanced Melanoma; ctDNA; treatment duration

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  To determine whether ctDNA can safely and feasibly guide ICI treatment duration decisions in patients with advanced melanoma by measuring the proportion of patients who demonstrate persistently undetectable ctDNA in the 12 months following treatment discontinuation

  12-month sustained ctDNA negativity rate after ICI discontinuation

Secondary Outcomes (3)

• Secondary Outcome 1

  1-year progression-free survival (PFS) among patients with undetectable ctDNA who discontinue ICI

• Secondary Outcome 2

  1-year overall survival (OS) among patients with undetectable ctDNA who discontinue ICI

• Outcome measure 3

  1-year treatment-free survival (TFS) among patients with undetectable ctDNA who discontinue ICI

Study Arms (1)

ctDNA Feasibility

EXPERIMENTAL

feasibility of utilizing ctDNA levels to inform immunotherapy treatment duration decisions in patients with advanced melanoma, in conjunction with standard imaging assessments to judge response.

Other: A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma

Interventions

A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma OTHER

This is a phase II pilot study evaluating the use of circulating tumor DNA (ctDNA) to guide the optimal duration of standard of care immune checkpoint inhibitor (ICI) therapy in patients with unresectable and/or metastatic melanoma who have radiographic evidence of disease control and/or response to treatment.

ctDNA Feasibility

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 with any subtype of unresectable stage III or stage IV melanoma treated with anti-PD-1-based ICI which includes both anti-PD-1 monotherapy and dual checkpoint inhibitor regimens such as ipilimumab plus nivolumab and nivolumab plus relatlimab.
• Disease control after at least 6-12 months of anti-PD-1-based ICI defined as a radiographic RECIST CR, PR, or SD and planned for at least 1 year of treatment
• Development of an irAE(s) on an anti-PD-1-based regimen requiring treatment interruption and immunosuppression where the investigator is considering treatment discontinuation. Patients must have a radiographic RECIST PR or CR at the treatment duration decision time point.
• Any line of therapy, with the exception of adjuvant therapy.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients with brain metastasis may be included only if there was also presence of extracranial disease.
• ECOG performance status 0-2.

You may not qualify if:

• Participants who are receiving investigational therapies.
• Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing.
• Intracranial-only metastatic melanoma.
• Patients with best response of progressive disease at time of screening.
• Patients who have had their melanoma completely surgically resected such that response to immunotherapy is no longer evaluable.
• Patients who are unwilling to continue or stop ICI therapy using ctDNA guidance in combination with imaging response.
• History of a life-threatening or severe irAE that would make ICI rechallenge unsafe. These cases will be discussed with the Principal Investigator.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (6)

• Amiot M, Mortier L, Dalle S, Dereure O, Dalac S, Dutriaux C, Leccia MT, Maubec E, Arnault JP, Brunet-Possenti F, De Quatrebarbes J, Granel-Brocard F, Gaudy-Marqueste C, Pages C, Stoebner PE, Saiag P, Lesimple T, Dupuy A, Legoupil D, Montaudie H, Oriano B, Lebbe C, Porcher R. When to stop immunotherapy for advanced melanoma: the emulated target trials. EClinicalMedicine. 2024 Dec 4;78:102960. doi: 10.1016/j.eclinm.2024.102960. eCollection 2024 Dec.

  PMID: 39717261 BACKGROUND

• Jansen YJL, Rozeman EA, Mason R, Goldinger SM, Geukes Foppen MH, Hoejberg L, Schmidt H, van Thienen JV, Haanen JBAG, Tiainen L, Svane IM, Makela S, Seremet T, Arance A, Dummer R, Bastholt L, Nyakas M, Straume O, Menzies AM, Long GV, Atkinson V, Blank CU, Neyns B. Discontinuation of anti-PD-1 antibody therapy in the absence of disease progression or treatment limiting toxicity: clinical outcomes in advanced melanoma. Ann Oncol. 2019 Jul 1;30(7):1154-1161. doi: 10.1093/annonc/mdz110.

  PMID: 30923820 BACKGROUND

• Robert C, Ribas A, Hamid O, Daud A, Wolchok JD, Joshua AM, Hwu WJ, Weber JS, Gangadhar TC, Joseph RW, Dronca R, Patnaik A, Zarour H, Kefford R, Hersey P, Zhang J, Anderson J, Diede SJ, Ebbinghaus S, Hodi FS. Durable Complete Response After Discontinuation of Pembrolizumab in Patients With Metastatic Melanoma. J Clin Oncol. 2018 Jun 10;36(17):1668-1674. doi: 10.1200/JCO.2017.75.6270. Epub 2017 Dec 28.

  PMID: 29283791 BACKGROUND

• Schroeder C, Gatidis S, Kelemen O, Schutz L, Bonzheim I, Muyas F, Martus P, Admard J, Armeanu-Ebinger S, Guckel B, Kustner T, Garbe C, Flatz L, Pfannenberg C, Ossowski S, Forschner A. Tumour-informed liquid biopsies to monitor advanced melanoma patients under immune checkpoint inhibition. Nat Commun. 2024 Oct 9;15(1):8750. doi: 10.1038/s41467-024-52923-0.

  PMID: 39384805 BACKGROUND

• Warburton L, Reid A, Amanuel B, Calapre L, Millward M, Gray E. Detectable ctDNA at the time of treatment cessation of ipilimumab and nivolumab for toxicity predicts disease progression in advanced melanoma patients. Front Oncol. 2023 Dec 19;13:1280730. doi: 10.3389/fonc.2023.1280730. eCollection 2023.

  PMID: 38179171 BACKGROUND

• Warburton L, Calapre L, Pereira MR, Reid A, Robinson C, Amanuel B, Ziman M, Millward M, Gray E. Circulating Tumour DNA in Advanced Melanoma Patients Ceasing PD1 Inhibition in the Absence of Disease Progression. Cancers (Basel). 2020 Nov 23;12(11):3486. doi: 10.3390/cancers12113486.

  PMID: 33238616 BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sarah Weiss, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Weiss, MD

CONTACT

732-235-2465; saweiss@cinj.rutgers.edu

Olutobi Adewale

CONTACT

732-235-2465; olutobi@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Medical Oncology

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)