Recruiting
Early Phase 1

CBL0137 & Ipilimumab, Nivolumab

Sponsor:

Fox Chase Cancer Center

Code:

NCT05498792

Conditions

Locally Advanced or Metastatic Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBL0137

Ipilimumab

Nivolumab

Study Details

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

Study ID

NCT05498792

Start date

Nov 30, 2022

Status verified date

May, 2026

Completion date

Sep 2, 2027

Anticipated

Primary completion date

Mar 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBL0137 (Dose level 1) +Ipilimumab + Nivolumab

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

experimental: CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab

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

experimental: CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab

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

Interventions

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)

Primary outcome measure

  • Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab. [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Principal Investigator:

Anthony J. Olszanski

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2026-05-22.