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New treatment option for High-grade Salivary Gland Carcinoma
Official title Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma
ClinicalTrials.gov ID: NCT05727410
What this study is testing
What is nivolumab, docetaxel, cisplatin Group?
nivolumab, docetaxel, cisplatin Group is an investigational medicine, being studied as a potential treatment for high-grade salivary gland 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
- 1. Primary Objective: \- Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor 2.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- people with histologically- or cytologically-confirmed resectable, clinically node-positive high grade salivary gland carcinoma Adenoid cystic...
- No previous chemotherapy treatment history
- Patients who have at least 1 measurable or non-measurable lesion per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before the...
- Strongly encourage (but not must) to provide newly obtained core or excisional biopsy of a tumor lesion not previously treated.
- ECOG Performance Status Score 0 or 1
You likely can't join if
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory...
- Has received prior systemic anti-cancer therapy including investigational agents except patient had no active treatment for past 5 years
- Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) for...
- Has received prior radiotherapy.
- Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product...
- Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
See the full eligibility criteria
Who can join
- people with histologically- or cytologically-confirmed resectable, clinically node-positive high grade salivary gland carcinoma Adenoid cystic carcinoma: Tubular/cribriform pattern predominant, Solid pattern \> 30%...
- No previous chemotherapy treatment history
- Patients who have at least 1 measurable or non-measurable lesion per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before the first does of investigational product.
- Strongly encourage (but not must) to provide newly obtained core or excisional biopsy of a tumor lesion not previously treated.
- ECOG Performance Status Score 0 or 1
- Patients with a life expectancy of at least 3 months
- Patients whose latest laboratory data meet the below criteria within 28 days before the first dose of the investigational product. If the date of the laboratory tests at the time of enrollment is not within 28 days...
- White blood cells ≥2,000/mm3 and neutrophils ≥1,500/mm3
- Platelets ≥50,000/mm3
- Hemoglobin ≥8.0 g/dL
- AST (GOT) and ALT (GPT) ≤3.0-fold the upper limit of normal (ULN) of the study site
- Total bilirubin ≤1.5-fold the ULN of the study site
- Creatinine ≤1.5-fold the ULN of the study site or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) \>45 mL/min
- Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5 months or more after...
- Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the investigational product, until 3 months or more after the last dose of docetaxel, and until 11...
- Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral...
- The subject must consent to use any two of the following methods of contraception: vasectomy or condom for patients who are male or female subject's partner and tubal ligation, contraceptive diaphragm, intrauterine...
What rules you out
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents except patient had no active treatment for past 5 years
- Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) for high-grade SGC before the first dose of the investigational product
- Has received prior radiotherapy.
- Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.
- Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
- Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment.
- Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
- Patients who have experienced a transient ischemic attack, cerebrovascular accident, or thrombosis within 180 days before enrollment
- Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
- Myocardial infarction within 180 days before enrollment
- Uncontrollable angina pectoris within 180 days before enrollment
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)
- Arrhythmia requiring treatment
- Patients with uncontrollable diabetes mellitus
- Patients with systemic infections requiring treatment
- Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before enrollment
- Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before enrollment
- Patients who have undergone surgery under general anesthesia within 28 days before enrollment
- Patients who have undergone surgery involving local or topical anesthesia within 14 days before enrollment
- Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before the first dose of the investigational product
- Women who are pregnant or breastfeeding, or possibly pregnant
- Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before enrollment
- Patients judged to be incapable of providing consent for reasons such as concurrent dementia
- Other patients judged by the investigator or sub-investigator to be inappropriate as people of this study
- Patient with current or past history of hypersensitivity to Nivolumab.
- Patients with current or past history of severe hypersensitivity to any other antibody products
- Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.