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

NCT05498792 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

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)

DRUG

Ipilimumab

Patient will be on Ipilimumab (1 mg/kg)

DRUG

Nivolumab

Patient will be on Nivolumab (3 mg/kg)

Sponsors & Collaborators

  • Incuron

    collaborator INDUSTRY

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Anthony Olszanski, MD · Fox Chase Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2027-03-04
Completion
2027-09-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498792 on ClinicalTrials.gov