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

ConditionLocally Advanced or Metastatic Melanoma

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorFox Chase Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

12 Participants

are divided into 3 treatment groups

Group A: CBL0137 (Dose level 1) +Ipilimumab + NivolumabExperimental treatment 3 interventions

Group B: CBL0137 ( Dose level 2) +Ipilimumab + NivolumabExperimental treatment 3 interventions

Group C: CBL0137 ( Dose level -1) +Ipilimumab + NivolumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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)

Time frame

28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fox Chase Cancer Center

Lead sponsor

Incuron

Collaborator

Source ClinicalTrials.gov

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