Status:
UNKNOWN
A Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Melanoma
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study assessed the safety and efficacy of individualized new antigen cancer vaccine combined with Programmed Cell Death Protein 1（PD1） inhibitor Toripalimab in the treatment of metastatic cutaneo...
Eligibility Criteria
Inclusion
- Patients must meet the following criteria on screening examination to be eligible to participate in the study:
- Patient is willing and able to give written informed consent.
- Age ≥ 18 years, ≤75 years
- Pathologically confirmed, clinically evident (by physical examination or radiographic imaging) stage IIIDN3c、IVM1a、M1b、M1c cutaneous melanoma.
- Lesions that can be measured，and at least one lesion that can be used to evaluate the efficacy of immunotherapy;Multiple biopsies are available for lesions.
- Patient is agreeable to allow tumor、normal tissue samples and blood samples to be submitted for genomic/complete exome/transcriptional sequencing；
- ECOG score is 0 or 1
- Life expectancy \>6 months
- Normal organ and bone marrow function as defined below:
- Leukocytes ≥ 3,500/mcL Absolute lymphocyte count \> 800/mcL Absolute neutrophil count \> 1,500/mcL Platelets \> 100,000/mcL Hemoglobin \> 10.0 g/dL Total serum bilirubin \< 1.0 x institutional upper limit of normal AST (SGOT)/ALT (SGPT) \< 2.0 x institutional upper limit of normal Serum creatinine\< 1.5 x institutional upper limit of normal
- Women of childbearing potential (WOCBP) must have a negative pregnancy test before entering the trial and within 7 days prior to start of study medication.
- Female patients enrolled in the study, short-term have no fertility plan and must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.
- Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.
- Good compliance, able to follow research protocols and follow-up procedures.
Exclusion
- Patients who meet any of the following criteria will not be eligible for this study.
- Uveal or mucosal melanoma；
- Patients who received immunotherapy or other targeted cancer therapy within 4 weeks (including, but not limited to: IL-2, CTLA-4 blockade, PD-1/PD-L1 blockade, but exception of INF-α given as adjuvant treatment)
- Previous bone marrow or stem cell transplant
- History of severe allergic reactions attributed to any vaccine therapy
- Active, known, or suspected autoimmune disease with the exception of vitiligo, type 1 diabetes, or psoriasis not requiring systemic treatment.
- Use of a non-oncology vaccine therapy for prevention of infectious diseases (up-to) 4 weeks prior to enrollment to the study. Patients may not receive any non-oncology vaccine therapy during the period of NeoVax administration and until at least 8 weeks after the last dose of study therapy
- In an immunosuppressive stage or immunosuppressive drugs were used systematically within 2 weeks.
- Patients with long-term use of glucocorticoids or with experimental anti-tumor drugs
- Active bacterial or fungal infections identified clinically (\>= level 2 of NCI-CTC edition 3);
- Known chronic infections with HIV, hepatitis B or C
- Known active or latent tuberculosis infection
- A history of idiopathic pulmonary fibrosis and organized pneumonia, or active pneumonia on chest computed tomography.
- Complicated with other tumors, except for cervical cancer in situ and basal cell carcinoma five years ago.
- Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;
- Drug abuse, Clinical, psychological or social factor result in affecting informed consent or research implementation.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04072900
Start Date
April 21 2020
End Date
September 1 2022
Last Update
April 28 2020
Active Locations (1)
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1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008