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

NCT05498792 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: MEL-21222-1028
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

EXPERIMENTAL

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

Drug: CBL0137; Drug: Ipilimumab; Drug: Nivolumab

CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab

EXPERIMENTAL

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

Drug: CBL0137; Drug: Ipilimumab; Drug: Nivolumab

CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab

EXPERIMENTAL

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

Drug: CBL0137; Drug: Ipilimumab; Drug: Nivolumab

Interventions

CBL0137 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)

Also known as: Curaxin

CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab; CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab; CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

Ipilimumab DRUG

Patient will be on Ipilimumab (1 mg/kg)

CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab; CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab; CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

Nivolumab DRUG

Patient will be on Nivolumab (3 mg/kg)

CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab; CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab; CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• 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:
• 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.
• Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
• Age \> 18 years
• ECOG performance status 0 or 1
• Patients must have normal organ and marrow function

You may not qualify if:

• Patients may not be receiving any other investigational agents
• Patients with a known active autoimmune disease
• Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
• Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
• Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Incuron: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

CBLC137; Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anthony Olszanski, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Olszanski, MD

CONTACT

2152141676; Anthony.Olszanski@fccc.edu

Tanu Singh, PhD

CONTACT

2152141439; Tanu.Singh@fccc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: November 30, 2022
• Primary Completion: March 4, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)