Personalized neoantigen peptide vaccine for advanced solid cancer

Phase 1

Recruiting

• Conditions: stage non- Metastatic cancer; small cell lung cancer (NSCLC), pancreatic cancer and melanoma; advanced- colorectal cancer (CRC), Immunotherapy, Neoantigen peptide vaccine&#44

• Registration Number: TCTR20191003001
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-03
• Study Completion: 2023-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

- Age > 18 years
- Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation
- The life expectancy of at least 3 months
- Eastern Cooperative Oncology (ECOG) performance status of 0 to 1
- Criteria specific to each tumor type:
- For NSCLC: Histologically confirmed the diagnosis of unresectable or
metastatic NSCLC 

- For CRC: Histologically confirmed the diagnosis of metastatic colorectal cancer

- For melanoma: Histologically confirmed the diagnosis of metastatic ovarian
cancer
- For pancreatic cancer: Histologically confirmed the diagnosis of unresectable
or metastatic pancreatic cancer

- Provide either a newly obtained or archival tissue sample sufficient for neoantigen peptide vaccine development. Newly obtained tissue is preferred.
- Adequate organ function

Exclusion Criteria

- History of severe hypersensitivity reaction to any peptide vaccines.
- Any active or suspected autoimmune diseases or a documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
- Prior immunotherapy including cell-based therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways within 3 months before the first dose of the study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate at week 9, 18 on treatment period and every 12 weeks until disease progression or up to 12 months modified RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Progression free survival at 6 month and 12 month modified RECIST 1.1,The incidence of grade 3 or 4 or greater toxicity During treatment and follow-up period NCI CTCAE v4.0,Overall survival at 6 month and 12 month medical record