BridgeMD
Tests treatment safety and results for Head and Neck Cancer Squamous Cell Carcinoma
Official title Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer
ClinicalTrials.gov ID: NCT06959082
What this study is testing
What is VS-101?
VS-101 is an investigational medicine, being studied as a potential treatment for head and neck cancer squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Defined by American Joint Committee on Cancer [AJCC] Guidelines 8th Edition:
- Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or
- Oropharyngeal p16 negative disease: Stage III, IVa, IVb per TNM guidelines; or
You likely can't join if
- Medical History
- Patients with a history of prior radiation to the head and neck region which overlap with the planned radiation fields (or cumulative doses exceed...
- Patients with active or uncontrolled or clinically significant medical or psychiatric disorders that, in the investigator's opinion, may interfere...
- Patients with a history of uncontrolled seizure disorder. Patients with a remote history of a single provoked seizure or well-controlled seizures on...
- Patients who are unable to swallow the study tablet at the screening visit, unless a nasogastric (NG) tube or percutaneous endoscopic gastrostomy...
- Patients who show abnormalities in the following test results at the time of screening:
See the full eligibility criteria
Who can join
- 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...
- Defined by American Joint Committee on Cancer [AJCC] Guidelines 8th Edition:
- Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or
- Oropharyngeal p16 negative disease: Stage III, IVa, IVb per TNM guidelines; or
- Oropharyngeal p16 positive disease: Stage III per TNM guidelines
- 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...
- 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
What rules you out
- Medical History
- Patients with a history of prior radiation to the head and neck region which overlap with the planned radiation fields (or cumulative doses exceed the constraints for organs-at-risk [OAR]) or with a known susceptibility...
- Patients with active or uncontrolled or clinically significant medical or psychiatric disorders that, in the investigator's opinion, may interfere with informed consent, adherence, or patient safety. Stable medical or...
- Patients with a history of uncontrolled seizure disorder. Patients with a remote history of a single provoked seizure or well-controlled seizures on stable monotherapy may be eligible.
- Patients who are unable to swallow the study tablet at the screening visit, unless a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube is already in place for clinically indicated reasons and the...
- Patients who show abnormalities in the following test results at the time of screening:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × upper limit of normal (ULN)
- Creatine clearance ≤50 mL/min (using Cockcroft-Gault (C-G) formula)
- Absolute neutrophil count (ANC) \<1,500/µL
- Platelets \<100,000/µL
- Hemoglobin \<9 g/dL
- Serum calcium \>1.5 × ULN
- Total bilirubin \> 2 × ULN
- Prothrombin time (PT) (International Normalized Ratio [INR]) \>1.5 × ULN or activated partial thromboplastin time (aPTT) (sec)
- Positive result for serum tests (hepatitis B or C virus, human immunodeficiency virus [HIV], rapid plasma reagin [RPR] test)
- Patients who show significant abnormalities in electrocardiogram (ECG) test results (e.g.,QTcF \> 450 msec)
- 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...
- 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 who have administered strong cytochrome P450 (CYP) 3A4 or CYP2D6 inducers or inhibitors within 14 days of baseline or 5 times the drug's half-life, whichever is longer.
- Participants who received chemotherapy within 14 days of baseline (drugs or treatment known to have anticancer effects such as cytotoxic chemotherapy, antihormonal therapy, and targeted therapy).
- Participants who required intravenous antibiotics, antivirals, or antifungals for active or uncontrolled infection at baseline.
- Participants who have administered benzodiazepines (e.g., lorazepam) that causes clinically significant sedation (stable low dose is permitted).
- Participants who participated in another clinical trial within 4 weeks of the baseline and administered the clinical trial drug
- 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...
- Participants who, in the judgment of other investigators, are not suitable to participate in the study"
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Manhattan, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Manhattan, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.