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NCT Number: NCT05498792

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

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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Key information

Conditions

Locally Advanced or Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location status: Recruiting

Location contact

Anthony J. Olszanski

CONTACT

[email protected]

215-214-1676

Anthony J. Olszanski

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Other names: Curaxin

Ipilimumab

Drug

Patient will be on Ipilimumab (1 mg/kg)

Nivolumab

Drug

Patient will be on Nivolumab (3 mg/kg)

Primary outcomes

  1. Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Olszanski, MD

CONTACT

[email protected]

2152141676

Tanu Singh, PhD

CONTACT

[email protected]

2152141439

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Incuron

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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