Status:
COMPLETED
Phase IIB TL + YCWP + DC in Melanoma
Lead Sponsor:
Elios Therapeutics, LLC
Collaborating Sponsors:
LumaBridge
Conditions:
Melanoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants...
Detailed Description
Stage III and Stage IV (resected) melanoma patients will be identified prior to definitive surgery and screened for inclusion/exclusion criteria. Eligible patients will be counseled and consented for ...
Eligibility Criteria
Inclusion
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1 (Appendix D)
- AJCC stage III or IV completely resectable melanoma identified before surgery
- Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
- Clinically disease-free after surgery
- Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
- Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
- Adequate organ function as determined by the following laboratory values:
- ANC ≥ 1,000/μL
- Platelets ≥ 75,000/μL
- Hgb ≥ 9 g/dL
- Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50%
- Total bilirubin ≤ 1.5 ULN
- ALT and AST ≤ 1.5 ULN
- For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
- Signed informed consent
Exclusion
- Evidence of residual disease after surgery and SoC adjuvant therapies
- Insufficient tumor available to produce vaccine
- ECOG \>2 performance status (Appendix D)
- Immune deficiency disease or known history of HIV, HBV, HCV
- Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
- Pregnancy (assessed by urine HCG)
- Breast feeding
- Active pulmonary disease requiring medication to include multiple inhalers (\>2 inhalers and one containing steroids)
- Involved in other experimental protocols (except with permission of the other study PI)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT02301611
Start Date
January 1 2015
End Date
May 11 2022
Last Update
November 29 2024
Active Locations (18)
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1
University of Alabama Birmingham (UAB) Comprehensive Cancer Center
Birmingham, Alabama, United States, 35243
2
Mayo Clinic - Cancer Clinical Research Office
Phoenix, Arizona, United States, 85054
3
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
The Angeles Clinic and Research Institute A Cedars-Sinai Affiliate
Los Angeles, California, United States, 90025