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

Locally Advanced or Metastatic Melanoma Clinical Trial

Official title:

MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05498792
• Other study ID #: MEL-212
• Secondary ID: 22-1028
• Status: Suspended
• Phase: Early Phase 1
• Start date: November 30, 2022
• Est. completion date: September 2, 2025

Study information

• Verified date: March 2024
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 12
• Est. completion date: September 2, 2025
• Est. primary completion date: March 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Melanoma
• Melanoma

Intervention

Drug:
• 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)
• Ipilimumab
Patient will be on Ipilimumab (1 mg/kg)
• Nivolumab
Patient will be on Nivolumab (3 mg/kg)

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	Incuron

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.	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)	28 days