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This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg of VS-101 + CRT | Experimental | 2 mg of VS-101 + CRT |
|
| 5 mg of VS-101 + CRT | Experimental | 5 mg of VS-101 + CRT |
|
| Only CRT | Placebo Comparator | Only CRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS-101 | Drug | VS-101 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The proportion of participants who achieve an ORR at 6 months and 12 months will be summarized with the 95% confidence interval on the mITT and PP samples. | 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | proportion of subjects who have a complete response (CR), partial response (PR), or stable disease (SD) at 6 months and 12 months will be summarized with the 95% confidence interval on the mITT and PP samples. | 6 months and 12 months |
| Best overall response (BOR) |
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Inclusion Criteria:
Males or females aged more than 18 years at the time of ICF signing
Diagnosed based on position emission tomography (PET), computed tomography (CT), or magnetic resonance imaging (MRI) with pathologically confirmed (histologic or cytological) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Defined by American Joint Committee on Cancer [AJCC] Guidelines 8th Edition:
Have measurable disease based on RECIST 1.1
Participants with head and neck cancer who have limited to those receiving definitive CRT without surgical excision
Participants prescribed standard intensity-modulated radiation therapy (IMRT) with a cumulative planned dose of approximately 70 Gy
Participants with Eastern Cooperative Oncology Group (ECOG) Performance Statue (PS) of 0 ~ 2
Participants with the status of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 Grade 2 if stable and not clinically significant, or lower for acute or chronic adverse reaction at the time of screening
Participants with an expected survival period of at least 20 weeks
Participants who can comply with the requirements of the clinical trial protocol
Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
Medical History
Patients who show abnormalities in the following test results at the time of screening:
Patients who received hypofractionated chemoradiation regimens (> 2 Gy per day) Note:If it is established that the abnormal lab values are a consequence of their underlying malignant disease rather than any other co-existing condition, reflect minor variations attributable to individual differences or testing conditions, and is not considered clinically significant, the Principal Investigator (PI) may discuss the case with the Medical Monitor to determine eligibility.
Patients with known hypersensitivity to components or excipients of clinical investigational drugs
Participants with a history of drug addiction within 3 months before ICF signing, unless a Urine drug screen negative result is obtained prior to randomization
Contraindicated Drugs and Treatments:
Participants and their spouses (or partners) with childbearing potential who are not using medically acceptable methods of contraception for the duration of the trial and for 14 months (in female participants) and 11 months (in male participants) after the last dose of cisplatin treatment
Participants who, in the judgment of other investigators, are not suitable to participate in the study"
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin |
| Drug |
Cisplatin |
|
| Radiation | Radiation | Radiation |
|
The BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. BOR will be summarized for the following categories: CR, PR, SD, PD and non-evaluable. |
| 6 months and 12 months |
| Progression-free survival (PFS) | The PFS will be analyzed using Kaplan-Meier methods on the mITT and PP samples. KM estimates and associated two-sided 95% confidence intervals will be presented for each cohort. Participants who have no documented progression and are still alive at the time of analysis will be censored at the time of the latest date of assessment. | At 6 month and 1 year |
| Locoregional control (LRC) | Rate of Locoregional recurrence after end of treatment (FDG-PET/CT scan). | At 6 month and 1 year |
| Distant metastasis (DM) | The proportion of participants who develop DM will be summarized with the 95% confidence interval on the mITT and PP samples | through study completion, at most 1 year |
| Overall survival (OS) | The OS will be analyzed using Kaplan-Meier methods on the mITT and PP samples. KM estimates and associated two-sided 95% confidence intervals will be presented for each cohort, and 1-year survival estimate will be calculated | 1 year |
| Changes in tumor size | Tumor imaging (CT and MRI) will be performed. | through study completion, at most 1 year |
| Number and severity of treatment-emergent adverse events (TEAEs), treatment-related AEs, and serious adverse events (SAEs) for all dose groups according to the NCICTCAE version 5.0 | AE will be measured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | through study completion, at most of 1 year |
| Health-related quality of life (HR-QoL) | FACT-H&N V4.
| at week1, week8, week11, week 19, week 27 and week 52 |
| NYU Langone Health | Recruiting | Manhattan | New York | 10016 | United States |
|
| D055585 |
| Physical Phenomena |