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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2026-09-02

Brief Summary

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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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Detailed Description

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The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Conditions

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Locally Advanced or Metastatic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

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

Group Type EXPERIMENTAL

CBL0137

Intervention Type DRUG

Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

Ipilimumab

Intervention Type DRUG

Patient will be on Ipilimumab (1 mg/kg)

Nivolumab

Intervention Type DRUG

Patient will be on Nivolumab (3 mg/kg)

CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab

Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Group Type EXPERIMENTAL

CBL0137

Intervention Type DRUG

Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

Ipilimumab

Intervention Type DRUG

Patient will be on Ipilimumab (1 mg/kg)

Nivolumab

Intervention Type DRUG

Patient will be on Nivolumab (3 mg/kg)

CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab

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

Group Type EXPERIMENTAL

CBL0137

Intervention Type DRUG

Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

Ipilimumab

Intervention Type DRUG

Patient will be on Ipilimumab (1 mg/kg)

Nivolumab

Intervention Type DRUG

Patient will be on Nivolumab (3 mg/kg)

Interventions

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CBL0137

Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

Intervention Type DRUG

Ipilimumab

Patient will be on Ipilimumab (1 mg/kg)

Intervention Type DRUG

Nivolumab

Patient will be on Nivolumab (3 mg/kg)

Intervention Type DRUG

Other Intervention Names

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Curaxin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No