Status:
UNKNOWN
Nivolumab, Ipilimumab and OTSGC-A24 Therapeutic Peptide Vaccine in Gastric Cancer - a Combination Immunotherapy Phase Ib Study.
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
OncoTherapy Science, Inc.
Bristol-Myers Squibb
Conditions:
Gastric Cancer
Eligibility:
All Genders
21-99 years
Phase:
PHASE1
Brief Summary
The primary hypothesis is that cancer vaccine can convert non-immunogenic gastric cancer into immunogenic phenotype susceptible to PD1 inhibition. This would lead to an improved radiological response ...
Detailed Description
Primary Objectives 1. Safety cohorts: To evaluate the safety of OTSGC-A24 and nivolumab (+ ipilimumab) in patients with refractory gastric cancer. 2. Arm A: To determine the objective response rate o...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed inoperable or metastatic gastric cancer that has failed or demonstrated intolerance to standard therapy - which includes platinum or fluoropyrimidine or taxane based chemotherapy.
- Patients must have measurable disease.
- Age ≥ 21 years
- ECOG performance status (PS) of 0 to 1
- Life expectancy at least 3 months
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
- Creatinine \<1.5x normal institutional limits
- Patients must be HLA-A\*24:02
- Patients must have recovered (\< grade 1) from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients receiving any other investigational products
- Patients who have previously received prior nivolumab or PD-/L1 blockade therapy
- Active autoimmune disease requiring disease-modifying therapy.
- Concurrent systemic steroid therapy higher than physiologic dose (equivalent of prednisolone 10mg daily)
- Any form of active primary or secondary immunodeficiency.
- History of significant gastrointestinal bleeding that required intervention within the prior 1 month is ineligible; inherited bleeding diathesis or coagulopathy.
- Serious non healing wound and peptic ulcer disease
- Previous history of intestinal perforation
- Symptomatic central nervous system (CNS) metastasis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension (systolic \>160 mmHg and/or diastolic \>100 mmHg), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction/cerebrovascular event (≤ 6 months prior to study entry), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, long term systemic immunosuppressant or corticosteroid, and active viral hepatitis.
- Women who are breast-feeding or pregnant are excluded from this study.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03784040
Start Date
February 21 2019
End Date
March 1 2024
Last Update
April 8 2019
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074