Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05498792

In fase di reclutamento

Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

Interventistico

Fase iniziale 1

Fox Chase Cancer Center

Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Farmaci, Inibitori dei Checkpoint

Mutazioni richieste

Nessuno

Studio Iniziato

2022-11-30

Ultimo Aggiornamento dello Sponsor

2025-04-04

Completamento Stimato

2026-03-04

Idoneità

Criteri di Inclusione

1. Patients must have:

1. Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and/or surgery OR:

2. Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.

3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.

2. Age > 18 years

3. ECOG performance status 0 or 1

4. Patients must have normal organ and marrow function

Criteri di Esclusione

1. Patients may not be receiving any other investigational agents

2. Patients with a known active autoimmune disease

3. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment

4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids

5. Patients with ongoing diarrhea (> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy

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Dettagli del Disegno

AllocazioneNon-Randomized

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare12

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Interventi:

CBL0137
Ipilimumab
Nivolumab

Misure di Esito

Misure di Esito Primarie

Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.28 days

The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)

Misure di Esito Secondarie

Nessuno

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Siti dello Studio

Questo studio ha 1 sito

Fox Chase Cancer Center
Philadelphia, Pennsylvania, US

In fase di reclutamento

Philadelphia, Pennsylvania, 19111 US

Fox Chase Cancer Center

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