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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07830225
Status
Recruiting

Conditions

  • Melanoma (Skin Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 3, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ctDNA Feasibility
    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.

Primary Outcome Measure

Primary Outcome [ Time Frame: 12-month sustained ctDNA negativity rate after ICI discontinuation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Olutobi Adewale
1 732-423-4822

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