Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Recruiting
Early Phase 1
Interventional Study
Locally Advanced or Metastatic Melanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- Fox Chase Cancer Center · Other
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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.
Trial Locations
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Eligibility Criteria
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 ser…
Contacts