RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive 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 traztuzumab, 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.

Official Title

A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

Quick Facts

Study Start:2023-03-03

Study Completion:2028-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05408845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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) * 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	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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)
* 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

* 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
* 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

Contacts and Locations

Principal Investigator

Alan L Ho

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Kaiser Permanente Dublin

Dublin, California, 94568

United States

Kaiser Permanente-Fremont

Fremont, California, 94538

United States

Kaiser Permanente-Fresno

Fresno, California, 93720

United States

City of Hope at Irvine Lennar

Irvine, California, 92618

United States

Kaiser Permanente-Modesto

Modesto, California, 95356

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

Kaiser Permanente-Roseville

Roseville, California, 95661

United States

Kaiser Permanente Downtown Commons

Sacramento, California, 95814

United States

Kaiser Permanente-South Sacramento

Sacramento, California, 95823

United States

Kaiser Permanente-San Francisco

San Francisco, California, 94115

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119

United States

Kaiser Permanente San Leandro

San Leandro, California, 94577

United States

Kaiser San Rafael-Gallinas

San Rafael, California, 94903

United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051

United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403

United States

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080

United States

Kaiser Permanente-Vallejo

Vallejo, California, 94589

United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Mount Sinai Chelsea

New York, New York, 10011

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Trinity's Tony Teramana Cancer Center

Steubenville, Ohio, 43952

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009

United States

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, 16001

United States

UPMC Camp Hill

Camp Hill, Pennsylvania, 17011

United States

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015

United States

UPMC Hillman Cancer Center - Passavant - Cranberry

Cranberry Township, Pennsylvania, 16066

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

IRMC Cancer Center

Indiana, Pennsylvania, 15701

United States

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901

United States

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, 15132

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

UPMC Hillman Cancer Center in Coraopolis

Moon, Pennsylvania, 15108

United States

UPMC Hillman Cancer Center - Part of Frick Hospital

Mount Pleasant, Pennsylvania, 15666

United States

Arnold Palmer Cancer Center Medical Oncology Norwin

N. Huntingdon, Pennsylvania, 15642

United States

UPMC Cancer Center-Natrona Heights

Natrona Heights, Pennsylvania, 15065

United States

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, 16105

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

UPMC-Mercy Hospital

Pittsburgh, Pennsylvania, 15219

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346

United States

UPMC Cancer Center-Uniontown

Uniontown, Pennsylvania, 15401

United States

UPMC Cancer Center-Washington

Washington, Pennsylvania, 15301

United States

Divine Providence Hospital

Williamsport, Pennsylvania, 17754

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Collaborators and Investigators

Sponsor: NRG Oncology

Alan L Ho, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-03

Study Completion Date2028-07-31

Study Record Updates

Study Start Date2023-03-03

Study Completion Date2028-07-31

Terms related to this study

Additional Relevant MeSH Terms

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