Metastatic Salivary Gland CarcinomaPhase 2NCT05408845
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Salivary Gland Carcinoma and Recurrent Salivary Gland Carcinoma, run by NRG Oncology at 154 sites in United States.
Trial summary
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 154 sitesUnited States
- Study dates
- 3 Mar 2023to 31 Jul 2033
- Phase
- Phase 2
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cancer (SGC)
- HER2-positive cohort:
- Note: The majority of HER2-positive SGCs are salivary duct carcinoma (SDCs), but to a lesser extent, other SGC subtypes can be HER2-positive (e.g., adenocarcinomas, mucoepidermoid carcinomas, etc.) and are eligible to be included on the study. Additionally, pathologists may sign out SDCs under other descriptors (e.g., ex-pleomorphic adenoma, adenocarcinoma), and these would be eligible if they are HER2-positive.
- Note: HER2 evaluation based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local/commercial next-generation sequencing (NGS) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for "HER2-positive":
- Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines
- Gene amplification by FISH (HER2/CEP17 ratio >= 2.0)
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- Gene amplification by NGS (fold change >= 2)
- HER2-low expressing cohort:
- Note: Local HER2 evaluation by immunohistochemistry (IHC) or fluorescent in-situ hybridization (FISH) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for "HER2-low":
- IHC 1+ per the College of American Pathologists (CAP) breast cancer guidelines
- IHC 2+ without evidence of amplification by FISH
- Patients with unresectable disease who are not candidates for curative surgery or radiation OR recurrent OR metastatic disease that is evident on radiologic imaging
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
- HER2-positive cohort: Measurable or non-measurable disease by the RECIST v1.1 criteria. HER2-low expressing cohort: Measurable disease by the RECIST v1.1 criteria
- History/physical examination within 30 days prior to registration
- The following imaging within 60 days prior to registration:
- CT or MRI of the neck (diagnostic quality with contrast, unless contraindicated) AND
- CT scan of the chest (diagnostic quality with contrast, unless contraindicated) AND
- If clinically indicated, CT or MRI of the abdomen and pelvis (diagnostic quality with contrast, unless contraindicated)
- Age >= 18
- Left ventricular ejection fraction (LVEF) >= 50% assessed by echocardiogram or multigated acquisition (MUGA) scan within 30 days prior to registration
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) Performance Status of 0-2 within 14 days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior to registration)
- Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration)
- Hemoglobin >= 9.0 g/dL (within 14 days prior to registration)
- HER2-positive cohort: Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dL is acceptable
- HER2-low expressing cohort: Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (granulocyte colony-stimulating factor [G-CSF]) is not allowed
- Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) >= 30 mL/min by the Cockcroft-Gault formula (within 14 days prior to registration)
- HER2-positive cohort: Total bilirubin =< 1.5 x ULN (within 14 days prior to registration) (Not applicable to patients with known Gilbert's syndrome) (within 14 days prior to registration)
- HER2-positive cohort: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x ULN (within 14 days prior to registration)
- HER2-low expressing cohort: Total bilirubin ≤ 1.5 x ULN if no liver metastases; or < 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases (within 14 days prior to registration) (within 14 days prior to registration)
- HER2-low expressing cohort: AST and ALT ≤ 3 x ULN if no liver metastases; or < 5 x ULN with liver metastases (within 14 days prior to registration)
- HER2-low expressing cohort: Serum albumin ≥ 2.5 g/dL (within 14 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Testing is not required for entry into protocol
- For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g., patients immunized against hepatitis B)
- For patients with a known history of hepatitis C virus (HCV) infection, they must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 7 months following last dose of study drug; this inclusion is necessary because the treatment in this study may be significantly teratogenic. Women must refrain from donating eggs during this same period
- Men with partners of childbearing potential must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 7 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period
- Prior to registration, patients who have had chemotherapy or palliative-intent radiotherapy must have all toxicities related to prior treatment recovered to ≤ grade 1
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Who cannot join
- HER2-positive cohort: Prior systemic therapy for the study cancer in the unresectable or recurrent and/or metastatic disease setting
- Note: Prior chemotherapy for a different cancer is allowed; prior androgen receptor targeted therapy in any setting is allowed; prior systemic therapy, including HER2-directed therapies given as neoadjuvant therapy, adjuvant therapy, and/or concurrently with radiation is allowed
- HER2-low expressing cohort: HER2 directed therapy for unresectable or recurrent or metastatic disease is not allowed
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
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- New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics, antivirals, or antifungals
- HER2-positive cohort only: >= grade 3 peripheral neuropathy
- Interstitial lung disease or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on chest CT scan
- Any hemorrhage or bleeding event grade >= 3 within 28 days prior to registration
- History of allergic reactions to compounds of similar chemical or biologic composition to: HER2-positive cohort: ado-trastuzumab emtansine, trastuzumab, and/or docetaxel (or any of their excipients). HER2-low expressing cohort: DS-8201a (trastuzumab deruxtecan), trastuzumab
- History of exposure to the following cumulative doses of anthracyclines:
- Doxorubicin or liposomal doxorubicin > 500 mg/m^2
- Epirubicin > 900 mg/m^2
- Mitoxantrone > 120 mg/m^2
- Note: If another anthracycline, or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of doxorubicin 500 mg/m^2
- HER2-low expressing cohort only: Receipt of live, attenuated vaccine (messenger ribonucleic acid [mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of DS-8201a (trastuzumab deruxtecan)
- Pregnancy and individuals unwilling to discontinue nursing
Trial locations and contacts
154 sites in 1 country. Contact the study team or a site near you to ask about taking part.
154 sites in 1 country
United States154 sites, 143 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Moises Harari-Turquie
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Dan P. Zandberg
- Active, not recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Paul L. Swiecicki
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Conor E. Steuer
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Daniel W. Bowles
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Active, not recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Site Public Contact, 617-638-8265
Peter C. Everett
- Recruiting
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Active, not recruiting
UPMC Camp Hill
Camp Hill, Pennsylvania, 17011
- Recruiting
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Dan P. Zandberg
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
John M. Kaczmar
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Kerri McGovern
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Marcelo R. Bonomi
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, 16066
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
UPMC Western Maryland
Cumberland, Maryland, 21502
Site Public Contact, 240-964-1400
Dan P. Zandberg
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Active, not recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
- Active, not recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Jennifer M. Suga
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Active, not recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
- Recruiting
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Dan P. Zandberg
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Jennifer M. Suga
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Dan P. Zandberg
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Dan P. Zandberg
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
HaysMed
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Prakash C. Neupane
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Site Public Contact, 720-848-0650
Daniel W. Bowles
- Recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Site Public Contact, 808-432-5195, shelley.a.clark@kp.org
Jennifer M. Suga
- Recruiting
IRMC Cancer Center
Indiana, Pennsylvania, 15701
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Active, not recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Dan S. Zuckerman
- Recruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Site Public Contact, 814-534-4724
Dan P. Zandberg
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Prakash C. Neupane
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
Site Public Contact, 913-588-3671
Prakash C. Neupane
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG
Prakash C. Neupane
- Recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Site Public Contact, 877-231-4440
Minh Phan
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Garrett T. Wasp
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Susanne M. Arnold
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132
Site Public Contact, 412-647-8073
Dan P. Zandberg
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Site Public Contact, 786-596-2000
Noah S. Kalman
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Stuart J. Wong
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356
Site Public Contact, 877-642-4691
Jennifer M. Suga
- Recruiting
Kaiser Permanente-Modesto
Modesto, California, 95356
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, 15108
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Recruiting
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Jennifer H. Choe
- Recruiting
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, 15065
Site Public Contact, 724-230-3030
Dan P. Zandberg
- Recruiting
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Active, not recruiting
Mount Sinai Chelsea
New York, New York, 10011
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Krzysztof J. Misiukiewicz
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Minh Phan
- Recruiting
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu
Prakash C. Neupane
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Site Public Contact, 650-498-7061, cancertrialsinfo@stanford.edu
Alexander D. Colevas
- Recruiting
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
Site Public Contact, 412-784-4900
Dan P. Zandberg
- Recruiting
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Site Public Contact, 800-533-8762
Dan P. Zandberg
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Dan P. Zandberg
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UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
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Dan P. Zandberg
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UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
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Dan P. Zandberg
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Erin R. Alesi
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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Kaiser Permanente-Roseville
Roseville, California, 95661
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Kaiser Permanente Downtown Commons
Sacramento, California, 95814
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Kaiser Permanente-South Sacramento
Sacramento, California, 95823
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Jennifer M. Suga
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Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
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Joleen M. Hubbard
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Regions Hospital
Saint Paul, Minnesota, 55101
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United Hospital
Saint Paul, Minnesota, 55102
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Salina Regional Health Center
Salina, Kansas, 67401
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
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Kathleen C. Kerrigan
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Kaiser Permanente-San Francisco
San Francisco, California, 94115
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Jennifer M. Suga
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UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
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Kaiser Permanente San Leandro
San Leandro, California, 94577
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Kaiser San Rafael-Gallinas
San Rafael, California, 94903
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Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
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Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
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Jennifer M. Suga
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Cristina P. Rodriguez
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Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
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UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
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Memorial Hospital East
Shiloh, Illinois, 62269
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Christine Auberle
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
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Daniel Almquist
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Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
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Washington University School of Medicine
St Louis, Missouri, 63110
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Siteman Cancer Center-South County
St Louis, Missouri, 63129
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Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
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Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, 43952
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
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University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
- Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
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UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, 15401
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Carle Cancer Center
Urbana, Illinois, 61801
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Prem Sobti
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Kaiser Permanente-Vallejo
Vallejo, California, 94589
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Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
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Jennifer M. Suga
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UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301
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Dan P. Zandberg
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UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
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Seema Harichand-Herdt
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UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
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Timothy R. Wassenaar
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University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
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Kerri McGovern
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The Iowa Clinic PC
West Des Moines, Iowa, 50266
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Seema Harichand-Herdt
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Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
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Seth O. Fagbemi
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
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Prakash C. Neupane
- Recruiting
Divine Providence Hospital
Williamsport, Pennsylvania, 17754
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Dan P. Zandberg
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UPMC Memorial
York, Pennsylvania, 17408
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Dan P. Zandberg
About this study
Official title: A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if trastuzumab emtansine (ado-trastuzumab emtansine [T-DM1]) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment. (HER2-Positive Cohort) II. To determine the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria with DS-8201a (trastuzumab deruxtecan) in R/M HER2-low expressing SGC patients. (HER2-Low Expressing Cohort)
SECONDARY OBJECTIVES:
- To compare the overall response rate (ORR) by RECIST v1.1 criteria between arms. (HER2-Positive Cohort) II. To compare overall survival (OS) between arms. (HER2-Positive Cohort) III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria between arms. (HER2-Positive Cohort) IV. To assess patient-reported toxicity, as measured by the patient reported outcome (PRO)-CTCAE, between arms, and explore patient-reported symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE. (HER2-Positive Cohort) V. To assess PFS with DS-8201a (trastuzumab deruxtecan) in HER2-low expressing SGC patients. (HER2-Low Expressing Cohort) VI. To assess OS with DS-8201a (trastuzumab deruxtecan) in HER2-low expressing SGC patients. (HER2-Low Expressing Cohort) VII. To evaluate toxicity of DS-8201a (trastuzumab deruxtecan) using CTCAE v5.0. (HER2-Low Expressing Cohort)
EXPLORATORY OBJECTIVES:
- To assess the ORR in patients who receive crossover treatment to T-DM1/TH following disease progression on the TH arm/T-DM1 arm.
II. To collect blood and tissue specimens for future translational science studies to examine how tumor genetics, HER2 signaling output/expression, HER2 tumoral heterogeneity, and androgen receptor expression/signaling impacts H and T-DM1 efficacy in the HER2-positive cohort and DS-8201a (trastuzumab deruxtecan) efficacy in the HER2-low expressing cohort.
OUTLINE: Patients with HER2-positive disease are randomized to 1 of 2 arms. Patients with HER2-low expression disease are assigned to Arm III.
ARM I: Patients receive docetaxel intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients on Arm I (TH) can cross over to Arm II (T-DM1) after first progression. Patients undergo a computed tomography (CT) scan or magnetic resonance imaging (MRI) and echocardiography (ECHO) or multigated acquisition (MUGA) scan throughout the trial. Patients may also undergo blood sample collection during screening and on study, as well as a biopsy during screening.
ARM II: Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients on Arm II (T-DM1) can cross over to Arm I (TH) after first progression. Patients undergo a CT scan or MRI and ECHO or MUGA scan throughout the trial. Patients may also undergo blood sample collection and during screening and on study, as well as a biopsy during screening.
ARM III: Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan or MRI and ECHO or MUGA scan throughout the trial. Patients may also undergo blood sample collection and during screening and on study, as well as a biopsy during screening.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for an additional 3-5 years, then annually.
- Conditions
- Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8, Stage IV Major Salivary Gland Cancer AJCC v8, Unresectable Salivary Gland Carcinoma
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Docetaxel, Echocardiography Test
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo a biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo a CT scan
DocetaxelDrug
Also called Docecad, RP 56976, RP-56976, RP56976
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
Questionnaire AdministrationOther
Ancillary studies
TrastuzumabBiological
Also called ABP 980, ALT02, Biceltis, CANMab
Given IV
Trastuzumab DeruxtecanBiological
Also called DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki
Given IV
Trastuzumab EmtansineBiological
Also called Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO 132365
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (docetaxel, trastuzumab) | Active comparator | Patients receive docetaxel IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients on Arm I (TH) can cross over to Arm II (T-DM1) after first progression. Patients undergo a CT scan or MRI throughout the trial. Patients may also undergo blood sample collection and during screening and on study, as well as a biopsy during screening. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Biological: Trastuzumab |
| Arm II (trastuzumab emtansine) | Experimental | Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients on Arm II (T-DM1) can cross over to Arm I (TH) after first progression. Patients undergo a CT scan or MRI throughout the trial. Patients may also undergo blood sample collection and during screening and on study, as well as a biopsy during screening. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Biological: Trastuzumab Emtansine |
| Arm III (trastuzumab deruxtecan) | Experimental | Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan or MRI and ECHO or MUGA scan throughout the trial. Patients may also undergo blood sample collection and during screening and on study, as well as a biopsy during screening. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Biological: Trastuzumab Deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) (HER2-Positive Cohort)
Kaplan-Meier method will be used to estimate PFS rates. A log-rank test will be used to assess whether trastuzumab emtansine (T-DM1) shows a signal of better PFS than the control arm. Cox proportional hazards models, including the stratification factors and with/out other key covariates (e.g., Zubrod performance status), will be used to estimate the treatment effect hazard ratio along with 80% and 95% confidence intervals.
Measured: From randomization to disease progression or death due to any cause, whichever occurs first, assessed up to 5 years
Objective response rate (ORR) (HER2-Low Expressing Cohort)
Overall tumor response in patients will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Defined as the proportion of subjects who achieved the best overall response (BOR) of complete response (CR) or partial response (PR). NOTE: For an individual patient, BOR is the best response (in the order of CR, PR, stable disease [SD], and progressive disease [PD]). Summary statistics of the ORR posterior distribution and 95% credible intervals will also be provided.
Measured: From the start of treatment up to a year or until the progression of disease, unacceptable toxicity, physician discretion to discontinue treatment, or patient withdrawal of consent, whichever occurs first.), assessed up to 5 years
Secondary outcomes (9)
ORR (HER2-Positive Cohort)
Overall tumor response in patients will be assessed according to RECIST 1.1. Only randomized patients who have measurable disease present at baseline will be considered evaluable for response. The ORR, defined as the proportion of complete and partial best overall responses (CR+PR) will be calculated with their respective 80% and 95% confidence intervals (CI) based normal approximations.
Measured: Up to 5 years
Duration of response (DOR) (HER2-Positive Cohort)
If the number of responders is sufficient, the Kaplan-Meier method will be used to estimate the DOR rates along with median of DOR and 95% CIs.
Measured: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Overall survival (OS) (HER2-Positive Cohort)
OS rates will be estimated using the Kaplan-Meier method, and between-arms comparison will be performed using a logrank test (0.10 one-sided significance level). Cox proportional hazards models with the stratification factors and with/out other key covariates (e.g., Zubrod performance status) will be used to estimate the treatment effect hazard ratio along with 80% and 95% confidence intervals.
Measured: Up to 5 years
Incidence of adverse events (HER2-Positive Cohort)
Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts of all adverse events (AEs) by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The proportion of patients with at least one grade 3 or higher AE will be compared between the treatment arms. All comparisons will be tested using a chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.10. In addition, 80% and 95% confidence intervals will be provided for these proportions.
Measured: Up to 30 days from last study treatment dose
Treatment discontinuations due to AEs (HER2-Positive Cohort)
The proportion of treatment discontinuations due to adverse events between arms will be compared using a chi-Square test (two-sided alpha of 0.10). In addition, 80% and 95% confidence intervals will be provided for these proportions. A two-group chi-square test with a 10% two-sided significance level will have 90% power to detect the difference between Arm 2 proportion of 0.15 and Arm 1 proportion of 0.40 (odds ratio of 3.8) when the number of randomized patients in each group is 58. These figures are reasonable based on data from breast cancer trials (40.9% versus [vs.] 7.2% for docetaxel plus trastuzumab [TH] and T-DM1 alone).
Measured: Up to 5 years
Patient-reported toxicity (HER2-Positive Cohort)
Patient-reported adverse events will be assessed using selected PRO-CTCAE.
Measured: Up to 5 years
OS (HER2-Low Expressing Cohort)
Will be estimated using the Kaplan-Meier method, and 95% pointwise confidence intervals for 1-year rates will be calculated using the log-log transformation.
Measured: Time from treatment initiation to death of any cause, assessed up to 5 years
PFS (HER2-Low Expressing Cohort)
Will be estimated using the Kaplan-Meier method, and 95% pointwise confidence intervals for 1-year rates will be calculated using the log-log transformation.
Measured: Time from treatment initiation to disease progression or death of any cause, assessed up to 5 years
Incidence of adverse events (HER2-Low Expressing Cohort)
AEs will be graded using CTCAE v5.0. Counts of all AEs by grade will be provided. Counts and frequencies will be provided for the worst grade AE experienced by the patient. The proportion of patients with at least one grade 3 or higher AE will be summarized.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start3 Mar 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Salivary Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alan L Ho, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408845
- Sponsor's protocol ID
- NRG-HN010
- Other IDs
- NCI-2022-04353, NRG-HN010, NRG-HN010, U10CA180868
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wotman MT, Khalaf A, Wang K, Meric-Bernstam F, Gillison ML, Akhave N, Kerrigan K, Ferrarotto R. Trastuzumab Deruxtecan in HER2-Low or HER2-Mutant Recurrent/Metastatic Secretory Gland Cancers of the Head and Neck: A Case Series. J Natl Compr Canc Netw. 2025 Nov 10;24(2):e257104. doi: 10.6004/jnccn.2025.7104.
PubMed 41213241