Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Melanoma | Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBL0137 | Drug | FACT Complex-targeting Curaxin CBL0137 | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- CBL0137 (Dose level 1) +Ipilimumab + Nivolumab
- description
- Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.
- interventionNames
- Drug: CBL0137
- Drug: Ipilimumab
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
- description
- Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.
- interventionNames
- Drug: CBL0137
- Drug: Ipilimumab
- Drug: Nivolumab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available