Head and Neck Squamous Cell Carcinoma MedDRA version: 16.1 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: S-488210
Pharmaceutical Form: Powder for injection
Current Sponsor code: S-488210
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed to be HLA-A*02:01-positive (Phase 1 part only) 2. Has unresectable locoregionally recurrent and/or metastatic HNSCC after failure of platinum based chemotherapy (including patients who are intolerant to platinum based chemotherapy due to adverse or toxic effects) 3. Has previously received platinum based chemotherapy containing either cisplatin or carboplatin as monotherapy or in combination with radiation 4. Has histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx 5. Has the presence of measurable disease as defined by response evaluation criteria in solid tumors (RECIST) that is confirmed on imaging within 4 weeks before enrollment 6. Has an ECOG PS of 0 or 1 within 2 weeks before enrollment 7. Has an expected life span of at least 3 months from the time of enrollment 8. Is willing and able to provide a tumor tissue sample 9. Is a male or female aged =18 years at enrollment 10. Has been informed of the full nature and purpose of the study, including possible risks and side effects, and has been given ample time and opportunity to read and understand this information, and has signed the ICF Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: 1. Has been treated with 3 or more chemotherapy regimens 2. Is human immunodeficiency virus positive, hepatitis B surface antigen positive, hepatitis C virus positive, or has other positive laboratory tests suggestive of active infection 3. Has human papilloma virus-positive tumor (Phase 2 part only) 4. Has any other malignant disease within the past 3 years, except for cervical carcinoma in situ or skin cancers other than melanoma 5. Has brain metastasis 6. Has received any of the following within 28 days of enrollment: anti malignant tumor drugs, immunosuppressants, corticosteroids, radiation therapy, immunotherapy, thermotherapy, and/or major surgery 7. Has an uncontrolled systemic or active infection 8. Has uncontrolled comorbidities such as hepatic insufficiency, renal insufficiency, heart failure, chronic obstructive pulmonary disease, bleeding disorders, or metabolic disease 9. Has an autoimmune disease including rheumatoid arthritis, systemic lupus erythematosus, or psoriasis 10. Has a current drug allergy or a past history of drug allergy 11. Has a past history of hypersensitivity to vaccines (eg, prophylactic vaccination) 12. Has received any systematic radiation therapy within 28 days of enrollment 13. Has inadequate bone marrow function, hepatic, or renal function test values that meet the following criteria within 2 weeks before enrollment: - White blood cell count 20 000/mm^3 - Platelet count 5 × the upper limit of the reference range - Total bilirubin >3 × the upper limit of the reference range - Serum creatinine >3 × the upper limit of the reference range 14. Is a female who is breastfeeding or pregnant, or who might be pregnant 15. Cannot or does not intend to use adequate means of contraception (barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel]; hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings]; or intrauterine devices) from enrollment until 12 weeks after final study drug administration 16. Has received another investigational product (including clinical study drugs) within 60 days of enrollment 17. Has received another investigational product (including clinical study drugs) within 28 days of enrollment, or still has adverse effects attributable to a previous investigational product at the time of screening 18. Has previously been genotyped for HLA status (Phase 2 part only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: * Phase 1 part To evaluate the safety and tolerability of S-488210 in HLA A*02:01-positive patients with head and neck squamous cell carcinoma (HNSCC) receiving 4 vaccinations of S-488210 * Phase 2 part To compare the overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients receiving S-488210;Secondary Objective: * Phase 1 part To evaluate the specific CTL response * Phase 2 part To evaluate: - The specific CTL response - The antitumor efficacy - The safety and tolerability - Any improvement in general health status based on EORTC QLQ-C30 and QLQ-H&N35 questionnaires - The progression-free survival - The overall survival;Primary end point(s): * Phase 1 part AE grades assessed by CTCAE Version 4.0; incidence and causality of AEs * Phase 2 part Comparison of overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients;Timepoint(s) of evaluation of this end point: Overall survival (OS) will be assessed for the Phase 1 part 6 months after the last patient has completed Step 1 of the Phase 1 part, when all patients complete Step 1 of the Phase 2 part, then 6, 12, and 18 months following completion of Step 1 of the Phase 2 part. Overall survival will be assessed for the Phase 2 part when all patients complete Step 1 of the Phase 2 part, then 6, 12, and 18 months following completion of Step 1 of the Phase 2 part. Patients who discontinue the study (either before or after Step 1) will also be followed up at these time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Phase 1 part Immune response, as evidenced by CTL induction rate * Phase 2 part - Immune response, as evidenced by CTL induction rate - Progression free survival - Overall survival - Antitumor efficacy, as evidenced by: objective response rate (complete response [CR] + partial response [PR] to the analysis population), overall response rate (CR + PR + stable disease [SD] to the analysis population) according to RECIST Version 1.1 - AE grades assessed by CTCAE Version 4.0; incidence and causality of AEs - Improvement in the general health status of patients compared with baseline based on the EORTC QLQ-C30 and QLQ-H&N35 questionnaires;Timepoint(s) of evaluation of this end point: OS and PFS Phase 1 6 months after the last patient has completed Step 1 of the Phase 1 part, when all patients complete Step 1 of the Phase 2, then 6, 12 and 18 months following completion of Step 1 of Phase 2. OS and PFS Phase 2 when all patients complete Step 1 of the Phase 2 part, then 6, 12 and 18 months following completion of Step 1 of the Phase 2 part Patients who discontinue the study (either before or after Step 1) will also be followed up at these time points. Blood samples for specific CTL measurement for Phases 1 and 2 at visit 1, 5, 9 and 13. Tumor evaluation will be assessed every 8 weeks for Phases 1 and 2. Any improvement in general health status of patients compared with baseline will be assessed every 8 weeks from previous until Visit 25 for Phases 1 and 2. | — |
Countries
Belgium, Germany
Contacts
Public ContactKenji Igarashi
Shionogi & Co., Ltd.
Outcome results
None listed