Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05498792

Recruiting

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

Interventional

Early Phase 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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Treatment Category

Other Drugs, Checkpoint Inhibitors

Required Mutations

None

Trial Started

2022-11-30

Last Updated by Sponsor

2025-04-04

Estimated Completion

2026-03-04

Eligibility

Inclusion Criteria

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

Exclusion Criteria

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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Design Details

AllocationNon-Randomized

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll12

Arms & Interventions

Arms

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

Outcome Measures

Primary Outcome Measures

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)

Secondary Outcome Measures

None

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Trial Sites

This study has 1 trial site

Fox Chase Cancer Center
Philadelphia, Pennsylvania, US

Recruiting

Philadelphia, Pennsylvania, 19111 US

Fox Chase Cancer Center

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