- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072900
A Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Melanoma
A Phase I Study With a Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Metastatic Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Xiang Chen, Doctor's
- Phone Number: +86-8975-3406
- Email: chenxiangck@126.com
Study Contact Backup
- Name: Juan Su, Doctor's
- Phone Number: _86-8432-8478
- Email: sujuanderm@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital, Central South University
-
Contact:
- Juan Su
- Phone Number: +86-8432-7128
- Email: sujuanderm@csu.edu.cn
-
Contact:
- Xiang Chen
- Phone Number: +86-8975-3406
- Email: chenxiangck@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention/Treatment
Personalized NeoAntigen Cancer Vaccine- Neo-Vac-Mn (peptides + rhGM-CSF+anti-PD1+Imiquimod 5% Topical Cream) NeoAntigen peptides:4 x 2 mg the total peptides given on days 84,87,91,98,105,133,and 161 Anti-PD-1 Toripalimab: 3mg/kg, ivgtt, Q2w rhGM-CSF: 3μg/kg given on Days 81,82,83,95,96,97,102,103,104,130,131,132,158,159,and 160 Imiquimod 5% Topical Cream:topical application on the injection site 6 hours before each NeoAntigen peptides injection |
4 x 3 mg all the peptides given on days 84,87,91,98,105,133,and 161
Other Names:
3mg/kg, ivgtt, Q2w
Other Names:
3μg/kg given on Days 81,82,83,95,96,97,102,103,104,130,131,132,158,159,and 160
topical application on the injection site 6 hours before each NeoAntigen peptides injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants experiencing adverse events
Time Frame: up to a maximum of 252 days
|
Number of participants experiencing clinical and laboratory adverse events (AE)
|
up to a maximum of 252 days
|
Number of Patients with Complete Remission Rate
Time Frame: up to a maximum of 252 days
|
Number of Patients with Complete Remission Rate(CRR)
|
up to a maximum of 252 days
|
Number of Patients with Progressive Disease
Time Frame: up to a maximum of 252 days
|
Number of Patients with Progressive Disease(PD)
|
up to a maximum of 252 days
|
Number of Patients with Partial Response
Time Frame: up to a maximum of 252 days
|
Number of Patients with Partial Response(PR)
|
up to a maximum of 252 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitoring of cellular immune response
Time Frame: up to a maximum of 252 days
|
the immune response of serum and tumor tissue
|
up to a maximum of 252 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xiang Chen, Doctor's, Xiangya Hospital of Central South University
Publications and helpful links
General Publications
- Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5. Erratum In: Nature. 2018 Mar 14;555(7696):402.
- Sahin U, Derhovanessian E, Miller M, Kloke BP, Simon P, Lower M, Bukur V, Tadmor AD, Luxemburger U, Schrors B, Omokoko T, Vormehr M, Albrecht C, Paruzynski A, Kuhn AN, Buck J, Heesch S, Schreeb KH, Muller F, Ortseifer I, Vogler I, Godehardt E, Attig S, Rae R, Breitkreuz A, Tolliver C, Suchan M, Martic G, Hohberger A, Sorn P, Diekmann J, Ciesla J, Waksmann O, Bruck AK, Witt M, Zillgen M, Rothermel A, Kasemann B, Langer D, Bolte S, Diken M, Kreiter S, Nemecek R, Gebhardt C, Grabbe S, Holler C, Utikal J, Huber C, Loquai C, Tureci O. Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer. Nature. 2017 Jul 13;547(7662):222-226. doi: 10.1038/nature23003. Epub 2017 Jul 5.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XYM001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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