NCT05498792RecruitingEarly phase 1
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 10 Aug 2022
- Start date
- 30 Nov 2022
- Primary completion date
- 4 Mar 2027
- Lead sponsor
- Fox Chase Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT05498792
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 12
- From 30 Nov 2022 to the primary completion date, 4 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients may not be receiving any other investigational agents
- 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
- Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy
Other illness
- Patients with a known active autoimmune disease
Who the study is looking for
- Patients must have:
- 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:
- 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
- Patients must have normal organ and marrow function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.