Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT05498792

Recrutement en cours

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

Interventionnel

Phase précoce 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.

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Catégorie de traitement

Autres médicaments, Inhibiteurs de points de contrôle

Mutations requises

Aucun

Essai commencé

2022-11-30

Dernière mise à jour par le sponsor

2025-04-04

Achèvement estimé

2026-03-04

Éligibilité

Critères d'inclusion

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

Critères d'exclusion

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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Détails de la conception

AllocationNon-Randomized

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire12

Bras et interventions

Bras

Interventions

Type : Experimental

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

Interventions :

CBL0137
Ipilimumab
Nivolumab

Mesures des résultats

Mesures des résultats primaires

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)

Mesures des résultats secondaires

Aucun

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Sites d'essai

Cette étude compte 1 site d'essai

Fox Chase Cancer Center
Philadelphia, Pennsylvania, US

Recrutement en cours

Philadelphia, Pennsylvania, 19111 US

Fox Chase Cancer Center

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