Locally Advanced or Metastatic MelanomaEarly Phase 1NCT05498792
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
A Early Phase 1 study testing CBL0137, Ipilimumab and Nivolumab in people with Locally Advanced or Metastatic Melanoma, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Melanoma
- What is being tested?
- CBL0137, Ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 2 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients may not be receiving any other investigational agents
- Patients with a known active autoimmune disease
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Anthony J. Olszanski, 215-214-1676, Anthony.Olszanski@fccc.edu
Anthony J. Olszanski
About this study
Official title: MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma
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.
Read the detailed description
The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
- Conditions
- Locally Advanced or Metastatic Melanoma
- Being tested
- CBL0137, Ipilimumab, Nivolumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL0137Drug
Also called Curaxin
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)
IpilimumabDrug
Patient will be on Ipilimumab (1 mg/kg)
NivolumabDrug
Patient will be on Nivolumab (3 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| CBL0137 (Dose level 1) +Ipilimumab + Nivolumab | Experimental | Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles. Receives: Drug: CBL0137; Drug: Ipilimumab; Drug: Nivolumab |
| CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab | Experimental | Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles. Receives: Drug: CBL0137; Drug: Ipilimumab; Drug: Nivolumab |
| CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab | Experimental | Dose level -1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles. Receives: Drug: CBL0137; Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start30 Nov 2022
- Primary completion4 Mar 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Incuron
- Responsible party
- Sponsor
- Investigators
- Anthony Olszanski, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498792
- Sponsor's protocol ID
- MEL-212
- Other IDs
- 22-1028
- Status last verified
- May 2026
- First submitted
- 10 Aug 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT05498792
- Acronym / sponsor ID
- MEL-212
- Conditions
- Locally Advanced or Metastatic Melanoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Incuron
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBL0137 (Dose level 1) +Ipilimumab + Nivolumab | Experimental | Drug: CBL0137, Drug: Ipilimumab, Drug: NivolumabDose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles. |
| CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab | Experimental | Drug: CBL0137, Drug: Ipilimumab, Drug: NivolumabDose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles. |
| CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab | Experimental | Drug: CBL0137, Drug: Ipilimumab, Drug: NivolumabDose level -1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have:
- Age > 18 years
- ECOG performance status 0 or 1
- Patients must have normal organ and marrow function
Key exclusion criteria (5 listed)
- Patients may not be receiving any other investigational agents
- Patients with a known active autoimmune disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL0137Also: CuraxinPatient 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) | Drug | CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab, CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab, CBL0137 (Dose level 1) +Ipilimumab + Nivolumab |
| IpilimumabPatient will be on Ipilimumab (1 mg/kg) | Drug | CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab, CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab, CBL0137 (Dose level 1) +Ipilimumab + Nivolumab |
| NivolumabPatient will be on Nivolumab (3 mg/kg) | Drug | CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab, CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab, CBL0137 (Dose level 1) +Ipilimumab + Nivolumab |
Primary outcome
Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
Time frame: 28 days
The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Olszanski, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CBL0137, Ipilimumab and Nivolumab in people with Locally Advanced or Metastatic Melanoma, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Olszanski, MD (2152141676, Anthony.Olszanski@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.