Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
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 as defined below.
- - Leukocytes > 3,000/mcL.
- - Absolute neutrophil count > 1,500/mcL.
- - Platelets > 100,000/mcL.
- - Hemoglobin ≥ 9 mg/dL.
- - Total bilirubin ≤ 1.52.0x ULN.
- - Patients with suspected Gilbert's disease may enroll provided that historic fluctuations in total bilirubin does not exceed 3 mg/dL.
- - Patient with known liver metastasis may enroll provided total bilirubin has been stable over the screening period and at least 2 weeks, and not exceeding 23 times upper limit of normal.
- - AST/ALT (SGOT/SGPT) < 35 times institutional normal limits.
- - Creatinine ≤ 2x normal institutional limits OR.
- - Creatinine clearance > 40 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
Exclusion Criteria:1. Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2. Patients may not be receiving any other investigational agents. 3. Patients with a known active autoimmune disease. 4. History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study. 5. Receiving or requiring the continued use of medications that are known to strongly inhibit or induce CYP3A4/5 (Appendix III). To participate in this study, such subjects should discontinue use of such agents for at least 2 weeks before cycle 1 day 1. 6. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment. 7. Uncontrolled intercurrent illness including, but not limited to, other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8. Patients on any other active malignancy that is likely to interfere with the safety or efficacy assessment of the investigational regimen. Need for concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy outside of the context of this protocol with the following exceptions: Adjuvant endocrine therapy for a history of breast cancer, endocrine therapy for patients with prostate cancer, somatastatin analogue use and hormone use (not including steroid use) for nonmalignant diseases. 9. Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with CBL0137. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. 10. Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to >470 msec (female subjects) or >450 msec (male subjects) based on a screening single 12-lead ECG. 11. Active bacterial fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral (Testing IS required for eligibility). a. Patients with treated hepatitis B or C, with no evidence of continued infection or requirement for antiviral medications, are permitted. 12. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids. 13. Patients with ongoing diarrhea (> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy. 14. Major surgery (as assessed by treating clinician) within 28 days of study registration. 15. Patients with clinically significant intracranial hemorrhage/hemorrhagic cardiovascular accident (CVA), or patients with gastrointestinal bleeding due to thrombocytopenia that has not resolved with medical therapy. 16. Pregnant or breast feeding. Refer to section 4.4 for further detail.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fox Chase Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Anthony Olszanski, MD|
|Principal Investigator Affiliation||Fox Chase Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Locally Advanced or Metastatic Melanoma|
The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
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.
Drug: - CBL0137
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)
Drug: - Ipilimumab
Patient will be on Ipilimumab (1 mg/kg)
Drug: - Nivolumab
Patient will be on Nivolumab (3 mg/kg)
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Anthony Olszanski, MD
For additional contact information, you can also visit the trial on clinicaltrials.gov.