Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Anjana Menon
- Telefonnummer: 813-745-5537
- E-post: Anjana.Menon@moffitt.org
Studieorter
-
-
Florida
-
Tampa, Florida, Förenta staterna, 33612
- Rekrytering
- Moffitt Cancer Center
-
Underutredare:
- Ahmad Tarhini, MD
-
Underutredare:
- Nikhil Khushalani, MD
-
Underutredare:
- Andrew Brohl, MD
-
Huvudutredare:
- Zeynep Eroglu, MD
-
Underutredare:
- Edith Abraham, MD
-
Underutredare:
- Lilit Karapetyan, MD
-
Underutredare:
- Joseph Markowitz, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age ≥18 years
- Histologically confirmed melanoma (excluding uveal melanoma)
- Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma
- Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma
- ECOG Performance Status ≤2
- Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN.
- Baseline imaging obtained within 28 days prior to treatment initiation
- Negative pregnancy test for women of childbearing potential
- Ability to understand and sign informed consent
Exclusion Criteria:
- Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment
- Contraindication to nivolumab and/or ipilimumab
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments
- Unresectable disease
- Uveal melanoma
- Any medical, psychiatric, or social condition that would interfere with protocol compliance or study participation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Neoadjuvant cohort
Patients with resectable stage III/IV melanoma eligible for neoadjuvant treatment will be enrolled. Patient cases will be reviewed with the surgery team to confirm surgical resectability prior to enrollment and CT imaging will be obtained at baseline, as per standard of care. |
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules. Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation. Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation. |
|
Experimentell: Adjuvant cohort
Patients who already underwent complete surgical resection of stage IIB/IIC/III/IV melanoma (and did not receive prior neoadjuvant treatment.) All patients in this cohort must be within 10 weeks of surgery and have CT scans post-surgery prior to study enrollment to confirm they are radiographically disease-free. Following study enrollment, all patients will have the first ctDNA analyses done within 12 weeks of date of surgery. |
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules. Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation. Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Event-Free Survival (EFS) in the Neoadjuvant Cohort
Tidsram: Up to 5 Years
|
Defined as the time from initiation of study treatment to disease progression precluding surgery, melanoma recurrence, progression, or death from any cause. |
Up to 5 Years
|
|
Relapse-Free Survival (RFS) in the Adjuvant Cohort
Tidsram: Up to 5 years
|
Defined as the time from initiation of adjuvant treatment to melanoma recurrence or death from any cause. |
Up to 5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pathologic Response Rate (Neoadjuvant Cohort)
Tidsram: Up to 12 weeks
|
Proportion of participants achieving pathologic response in the surgical specimen following neoadjuvant treatment, including pathologic complete response (pCR) and major pathologic response (MPR). |
Up to 12 weeks
|
|
Objective Response Rate (ORR) by RECIST v1.1 (Neoadjuvant Cohort)
Tidsram: Up to 12 weeks
|
Proportion of participants achieving a complete response or partial response according to RECIST version 1.1 based on radiographic assessments performed during neoadjuvant treatment. |
Up to 12 weeks
|
|
Relapse With Undetectable ctDNA
Tidsram: Up to 5 years
|
Frequency of participants who maintain undetectable circulating tumor DNA (ctDNA) during serial monitoring and subsequently experience clinical and/or radiographic melanoma relapse. |
Up to 5 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Zeynep Eroglu, MD, Moffitt Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Hudsjukdomar
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neuroendokrina tumörer
- Nevi och melanom
- Neoplasmer i huden
- Hud- och bindvävssjukdomar
- Melanom
- Aminosyror, peptider och proteiner
- Proteiner
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Nivolumab
- Ipilimumab
Andra studie-ID-nummer
- MCC-23763
Läkemedels- och apparatinformation, studiedokument
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