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Trial Title: Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

NCT ID: NCT05498792

Condition: Locally Advanced or Metastatic Melanoma

Conditions: Official terms:
Melanoma
Nivolumab
Ipilimumab

Study type: Interventional

Study phase: Early Phase 1

Overall status: Suspended

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CBL0137
Description: 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)
Arm group label: CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab
Arm group label: CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
Arm group label: CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

Other name: Curaxin

Intervention type: Drug
Intervention name: Ipilimumab
Description: Patient will be on Ipilimumab (1 mg/kg)
Arm group label: CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab
Arm group label: CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
Arm group label: CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

Intervention type: Drug
Intervention name: Nivolumab
Description: Patient will be on Nivolumab (3 mg/kg)
Arm group label: CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab
Arm group label: CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
Arm group label: CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

Summary: 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.

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

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fox Chase Cancer Center

Address:
City: Philadelphia
Zip: 19111
Country: United States

Start date: November 30, 2022

Completion date: September 2, 2025

Lead sponsor:
Agency: Fox Chase Cancer Center
Agency class: Other

Collaborator:
Agency: Incuron
Agency class: Industry

Source: Fox Chase Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05498792

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