High-grade Salivary Gland CarcinomaPhase 2NCT05727410
Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma
A Phase 2 study testing nivolumab, docetaxel, cisplatin Group in people with High-grade Salivary Gland Carcinoma, run by Myung-Ju Ahn at 1 site in South Korea.
Trial summary
1. Primary Objective: Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor 2. Secondary Objectives: Complete resection rate Response rate to neoadjuvant therapy according to RECIST 1.1 Downstaging at pathologic staging compared to clinical staging performed at study entry Distant… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- High-grade Salivary Gland Carcinoma
- What is being tested?
- nivolumab, docetaxel, cisplatin Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2022to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically- or cytologically-confirmed resectable, clinically node-positive high grade salivary gland carcinoma Adenoid cystic carcinoma: Tubular/cribriform pattern predominant, Solid pattern > 30% Poorly differentiated carcinoma Mucoepidermoid carcinoma, High grade Polymorphous adenocarcinoma, High grade Lymphoepithelial carcinoma Salivary duct carcinoma Adenocarcinoma, NOS, High grade Carcinosarcoma Squamous cell carcinoma Carcinoma ex pleomorphic adenoma - risk is determined by type of carcinoma and extent of invasion
- 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
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- 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 before the first dose of the investigational product, testing must be repeated within 28 days before the first dose of the investigational product, and these latest laboratory tests must meet the following criteria.
- 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 the last dose of the investigational product. Women must agree to use contraception#2 from the time of informed consent until 6 months or more after the last dose of docetaxel and 14 months or more after the last dose of cisplatin. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product. Women must agree not to breastfeed from the time of informed consent until 1 week or more after the last dose of docetaxel. Cisplatin has been reported to be found in human milk; women must agree not to breastfeed while receiving cisplatin.
- 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 months or more after the last dose of cisplatin.
- 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 oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.
- 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 device, spermicide, or oral contraceptive for patients who are female or male subject's partner.
Who cannot join
- 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
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- 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 subjects 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
Myung-Ju Ahn, M.D., +82-2-3410-3438, silk.ahn@samsung.com
About this study
Official title: A Phase II Trial of Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma
- Primary Objective:
- Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor
Read more
- Secondary Objectives:
- Complete resection rate
- Response rate to neoadjuvant therapy according to RECIST 1.1
- Downstaging at pathologic staging compared to clinical staging performed at study entry
- Distant metastasis free survival (DMFS) rate at 2 years
- Disease free survival at 2 years
- Overall survival rate at 2 years
- Safety and feasibility
- Exploratory Objectives:
- PD L1 expression by 28-8 immunohistochemistry
- IHC (HER2, AR, etc)
- Whole exome sequencing (WES)
- Whole transcriptome sequencing (WTS)
- Peripheral blood biomarkers (CD4+ T cells, CD8+ T cell, myeloid derived suppressor cells (MDSC), Treg etc)
- Interferon gamma related gene expression profile
- Multiplex florescence measure of tumor cells and tumor microenvironment cells
Read the detailed description
This is a phase II, single center, open-label, single arm study in patients with resectable, high grade salivary gland carcinoma. Patients will be treated with nivolumab 360mg and plus docetaxel 60mg/m2 and cisplatin 60mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive radiation 59.4 Gy in 27 fractions. Boost RT of 6.6 Gy in 3 fractions to tumor bed and/or gross tumor will be optional in patients who had R1-R2 resection. If tumors are regarded inoperable after neoadjuvant therapy (due to high risk of post-operative complication, or metastatic disease), they will be off from this study and receive the appropriate treatment, though they will be also included in the efficacy and safety analyses.
- Conditions
- High-grade Salivary Gland Carcinoma
- Being tested
- nivolumab, docetaxel, cisplatin Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumab, docetaxel, cisplatin GroupDrug
Patients will be treated with nivolumab 360mg and plus docetaxel 60mg/m2 and cisplatin 60mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive radiation 59.4 Gy in 27 fractions. Boost RT of 6.6 Gy in 3 fractions to tumor bed and/or gross tumor will be optional in patients who had R1-R2 resection. If tumors are regarded inoperable after neoadjuvant therapy (due to high risk of post-operative complication, or metastatic disease), they will be off from this study and receive the appropriate treatment, though they will be also included in the efficacy and safety analyses.
| Study group | Role | What they receive |
|---|---|---|
| nivolumab, docetaxel, cisplatin Group | Experimental | nivolumab, docetaxel, cisplatin (IV infusion every 3 weeks) Receives: Drug: nivolumab, docetaxel, cisplatin Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor
Primary tumors were assessed for the percentage of residual viable tumor that was identified on routine hematoxylin and eosin staining, and tumors with no more than 10% viable tumor cells were considered to have had a major pathological response. Patients who have progressive disease after neoadjuvant therapy and drop out from the study population will be counted as patients without major pathologic response.
Measured: 6 months
Secondary outcomes (7)
Complete resection rate
Complete resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. Complete resection rate is defined as the percentage of the patients that underwent a resection and had a microscopically complete (or R0) resection.
Measured: Up to 24 months
Response rate to neoadjuvant therapy according to RECIST 1.1
RECIST 1.1 will be used as the primary measure for assessment of tumor response, date of disease progression, and as a basis for all protocol guidelines related to disease status (eg, discontinuation of study treatment).
Measured: Up to 24 months
Downstaging at pathologic staging compared to clinical staging performed at study entry
Downstaging defined as pathologic TNM less than clinical TNM. Cancer staging calculator(AJCC 8th Edition)
Measured: Up to 24 months
Distant metastasis free survival (DMFS) rate at 2 years
Distant metastases free survival (DMFS) is defined as the time between date of enrollment and the date of first diagnosis of distant metastasis or death, whichever comes first. Patients in whom distant metastases are discovered during neoadjuvant chemo/immunotherapy or the evaluation thereafter or at the immediate surgery, are considered to have an event at that time point.
Measured: Up to 24 months
Disease free survival at 2 years
Patients that have undergone a resection and are alive without distant metastases (regardless of locoregional failure) are censored at the last date available.
Measured: Up to 24 months
Overall survival rate at 2 years
Overall survival (OS) and is defined as the time between date of enrollment and date of death from any cause. Patients alive at last follow-up are censored at the last date available.
Measured: Up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Who dose discontinued due to adverse event.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start15 Nov 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Salivary Gland CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myung-Ju Ahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Myung-Ju Ahn, Samsung Medical Center
- Investigators
- Myung-Ju Ahn, Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727410
- Sponsor's protocol ID
- 2022-02-103
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Nivolumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Radiation Therapy for Resectable High Grade Salivary Gland Carcinoma
- ClinicalTrials.gov ID
- NCT05727410
- Acronym / sponsor ID
- 2022-02-103
- Conditions
- High-grade Salivary Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Myung-Ju AhnUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Primary Objective:
- Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor
- Secondary Objectives:
- Complete resection rate
- Response rate to neoadjuvant therapy according to RECIST 1.1
- Downstaging at pathologic staging compared to clinical staging performed at study entry
- Distant metastasis free survival (DMFS) rate at 2 years
- Disease free survival at 2 years
- Overall survival rate at 2 years
- Safety and feasibility
- Exploratory Objectives:
- PD L1 expression by 28-8 immunohistochemistry
- IHC (HER2, AR, etc)
- Whole exome sequencing (WES)
- Whole transcriptome sequencing (WTS)
- Peripheral blood biomarkers (CD4+ T cells, CD8+ T cell, myeloid derived suppressor cells (MDSC), Treg etc)
- Interferon gamma related gene expression profile
- Multiplex florescence measure of tumor cells and tumor microenvironment cells
Detailed description
This is a phase II, single center, open-label, single arm study in patients with resectable, high grade salivary gland carcinoma. Patients will be treated with nivolumab 360mg and plus docetaxel 60mg/m2 and cisplatin 60mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive radiation 59.4 Gy in 27 fractions. Boost RT of 6.6 Gy in 3 fractions to tumor bed and/or gross tumor will be optional in patients who had R1-R2 resection. If tumors are regarded inoperable after neoadjuvant therapy (due to high risk of post-operative complication, or metastatic disease), they will be off from this study and receive the appropriate treatment, though they will be also included in the efficacy and safety analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center trial
| Arm | Type | Receives |
|---|---|---|
| nivolumab, docetaxel, cisplatin Group | Experimental | Drug: nivolumab, docetaxel, cisplatin Groupnivolumab, docetaxel, cisplatin (IV infusion every 3 weeks) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects with histologically- or cytologically-confirmed resectable, clinically node-positive high grade salivary gland carcinoma Adenoid cystic carcinoma: Tubular/cribriform pattern predominant, Solid pattern > 30% Poorly differentiated carcinoma Mucoepidermoid carcinoma, High grade Polymorphous adenocarcinoma, High grade Lymphoepithelial carcinoma Salivary duct carcinoma Adenocarcinoma, NOS, High grade Carcinosarcoma Squamous cell carcinoma Carcinoma ex pleomorphic adenoma - risk is determined by type of carcinoma and extent of invasion
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumab, docetaxel, cisplatin GroupPatients will be treated with nivolumab 360mg and plus docetaxel 60mg/m2 and cisplatin 60mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive radiation 59.4 Gy in 27 fractions. Boost RT of 6.6 Gy in 3 fractions to tumor bed and/or gross tumor will be optional in patients who had R1-R2 resection. If tumors are regarded inoperable after neoadjuvant therapy (due to high risk of post-operative complication, or metastatic disease), they will be off from this study and receive the appropriate treatment, though they will be also included in the efficacy and safety analyses. | Drug | nivolumab, docetaxel, cisplatin Group |
Primary outcome
Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor
Time frame: 6 months
Primary tumors were assessed for the percentage of residual viable tumor that was identified on routine hematoxylin and eosin staining, and tumors with no more than 10% viable tumor cells were considered to have had a major pathological response. Patients who have progressive disease after neoadjuvant therapy and drop out from the study population will be counted as patients without major pathologic response.
7 secondary outcomes
Complete resection rate
Time frame: Up to 24 months
Response rate to neoadjuvant therapy according to RECIST 1.1
Time frame: Up to 24 months
Downstaging at pathologic staging compared to clinical staging performed at study entry
Time frame: Up to 24 months
Distant metastasis free survival (DMFS) rate at 2 years
Time frame: Up to 24 months
Disease free survival at 2 years
Time frame: Up to 24 months
Overall survival rate at 2 years
Time frame: Up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Ju Ahn, Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nivolumab, docetaxel, cisplatin Group in people with High-grade Salivary Gland Carcinoma, run by Myung-Ju Ahn at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Ju Ahn, Ph.D. (+82-2-3410-1359, silk.ahn@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.