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

Conditions

• Locally Advanced or Metastatic Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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)
• Ipilimumab — DRUG
  Patient will be on Ipilimumab (1 mg/kg)
• Nivolumab — DRUG
  Patient will be on Nivolumab (3 mg/kg)

Study Details

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.

Key Dates

Start date

Nov 30, 2022

Status verified

May 2026

Primary completion

Mar 4, 2027

Completion

Sep 2, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Anthony Olszanski, MD
  2152141676
  [email protected]
• Tanu Singh, PhD
  2152141439
  [email protected]

Locations (1)

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