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

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About this study

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.

Condition
Melanoma (Skin Cancer)
Tested
A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma
Sponsor
Rutgers, The State University of New Jersey

Who can join

Age
18 to 90 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 90 years
  • Study condition: Melanoma (Skin Cancer)
  • 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.

Exclusion 8

  • 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.

Where

1 site, 1 recruiting

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.