Recruiting
Phase 2

Ado-Trastuzumab Emtansine vs. Chemotherapy

Sponsor:

NRG Oncology

Code:

NCT05408845

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Computed Tomography

Docetaxel

Echocardiography Test

Study Details

Brief 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-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.

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

Study ID

NCT05408845

Start date

Mar 3, 2023

Status verified date

Aug, 2026

Completion date

Jul 31, 2032

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (docetaxel, trastuzumab)

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.

experimental: Arm II (trastuzumab emtansine)

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.

experimental: Arm III (trastuzumab deruxtecan)

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.

Interventions

Biopsy Procedure

Undergo a biopsy

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo a CT scan

Docetaxel

Given IV

Echocardiography Test

Undergo ECHO

Magnetic Resonance Imaging

Undergo MRI

Multigated Acquisition Scan

Undergo MUGA

Questionnaire Administration

Ancillary studies

Trastuzumab

Given IV

Trastuzumab Deruxtecan

Given IV

Trastuzumab Emtansine

Given IV

Primary outcome measure

  • Progression free survival (PFS) (HER2-Positive Cohort) [ Time Frame: 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) [ Time Frame: 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 yeats ]

Central Contacts and Locations

Locations

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Fresno

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente- Modesto MOB II

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Modesto

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Public Contact

650-498-7061ccto-office@stanford.edu

Principal Investigator:

Alexander D. Colevas

Kaiser Permanente-Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Downtown Commons

Recruiting

Sacramento, California, United States, 95814

Contacts

Site Public Contact

877-642-4691kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente San Leandro

Recruiting

San Leandro, California, United States, 94577

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Medical Center - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-South San Francisco

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Walnut Creek

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Daniel W. Bowles

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Daniel W. Bowles

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

786-596-2000

Principal Investigator:

Noah S. Kalman

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Conor E. Steuer

Kaiser Permanente Moanalua Medical Center

Recruiting

Honolulu, Hawaii, United States, 96819

Contacts

Site Public Contact

808-432-5195shelley.a.clark@kp.org

Principal Investigator:

Jennifer M. Suga

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Twin Falls

Recruiting

Twin Falls, Idaho, United States, 83301

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Prem Sobti

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Prem Sobti

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Prem Sobti

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Site Public Contact

314-747-9912dschwab@wustl.edu

Principal Investigator:

Christine Auberle

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Prem Sobti

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Saint Anthony Regional Hospital

Recruiting

Carroll, Iowa, United States, 51401

Contacts

Site Public Contact

515-689-7658sbenson@iora.org

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Broadlawns Medical Center

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-282-2200

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Healthcare Mission Cancer and Blood - Fort Dodge

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Site Public Contact

515-282-2921trials@missioncancer.com

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

The Iowa Clinic PC

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-875-9815

Principal Investigator:

Seema Harichand-Herdt

HaysMed

Recruiting

Hays, Kansas, United States, 67601

Contacts

Site Public Contact

785-623-5774

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Prakash C. Neupane

Lawrence Memorial Hospital

Recruiting

Lawrence, Kansas, United States, 66044

Contacts

Site Public Contact

785-505-2800Stephanie.Norris@LMH.ORG

Principal Investigator:

Prakash C. Neupane

The University of Kansas Cancer Center - Olathe

Recruiting

Olathe, Kansas, United States, 66061

Contacts

Site Public Contact

913-588-1569OlatheCCResearch@kumc.edu

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Prakash C. Neupane

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Prakash C. Neupane

Salina Regional Health Center

Recruiting

Salina, Kansas, United States, 67401

Contacts

Site Public Contact

785-452-7038mleepers@srhc.com

Principal Investigator:

Prakash C. Neupane

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000

Principal Investigator:

Prakash C. Neupane

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Prakash C. Neupane

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Susanne M. Arnold

UPMC Western Maryland

Recruiting

Cumberland, Maryland, United States, 21502

Contacts

Site Public Contact

240-964-1400

Principal Investigator:

Dan P. Zandberg

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Site Public Contact

617-638-8265

Principal Investigator:

Peter C. Everett

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Paul L. Swiecicki

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Site Public Contact

218-333-5000OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Katharine A. Price

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Christine Auberle

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Christine Auberle

University Health Truman Medical Center

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-404-4375

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Prakash C. Neupane

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Christine Auberle

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Christine Auberle

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Christine Auberle

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Site Public Contact

800-639-6918cancer.research.nurse@dartmouth.edu

Principal Investigator:

Garrett T. Wasp

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Moises Harari-Turquie

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Krzysztof J. Misiukiewicz

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-234-6161OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Kerri McGovern

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Marcelo R. Bonomi

Trinity's Tony Teramana Cancer Center

Recruiting

Steubenville, Ohio, United States, 43952

Contacts

Site Public Contact

888-874-7000

Principal Investigator:

Dan P. Zandberg

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Kerri McGovern

Cancer Centers of Southwest Oklahoma Research

Recruiting

Lawton, Oklahoma, United States, 73505

Contacts

Site Public Contact

877-231-4440

Principal Investigator:

Minh Phan

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Minh Phan

UPMC Altoona

Recruiting

Altoona, Pennsylvania, United States, 16601

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Dan P. Zandberg

UPMC-Heritage Valley Health System Beaver

Recruiting

Beaver, Pennsylvania, United States, 15009

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center at Butler Health System

Recruiting

Butler, Pennsylvania, United States, 16001

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

Carlisle Regional Cancer Center

Recruiting

Carlisle, Pennsylvania, United States, 17015

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center - Passavant - Cranberry

Recruiting

Cranberry Township, Pennsylvania, United States, 16066

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Dan P. Zandberg

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Recruiting

Harrisburg, Pennsylvania, United States, 17109

Contacts

Site Public Contact

717-724-6765klitchfield@PINNACLEHEALTH.org

Principal Investigator:

Dan P. Zandberg

IRMC Cancer Center

Recruiting

Indiana, Pennsylvania, United States, 15701

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Recruiting

Johnstown, Pennsylvania, United States, 15901

Contacts

Site Public Contact

814-534-4724

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center at UPMC McKeesport

Recruiting

McKeesport, Pennsylvania, United States, 15132

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center in Coraopolis

Recruiting

Moon Township, Pennsylvania, United States, 15108

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center - Part of Frick Hospital

Recruiting

Mount Pleasant, Pennsylvania, United States, 15666

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

Arnold Palmer Cancer Center Medical Oncology Norwin

Recruiting

N. Huntingdon, Pennsylvania, United States, 15642

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center-Natrona Heights

Recruiting

Natrona Heights, Pennsylvania, United States, 15065

Contacts

Site Public Contact

724-230-3030

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center - New Castle

Recruiting

New Castle, Pennsylvania, United States, 16105

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC-Saint Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Site Public Contact

412-784-4900

Principal Investigator:

Dan P. Zandberg

UPMC-Mercy Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Site Public Contact

800-533-8762

Principal Investigator:

Dan P. Zandberg

University of Pittsburgh Cancer Institute (UPCI)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Dan P. Zandberg

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Dan P. Zandberg

UPMC-Saint Clair Hospital Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

Site Public Contact

412-502-3920

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center at UPMC Northwest

Recruiting

Seneca, Pennsylvania, United States, 16346

Contacts

Site Public Contact

814-676-7900

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center-Uniontown

Recruiting

Uniontown, Pennsylvania, United States, 15401

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center-Washington

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Dan P. Zandberg

Divine Providence Hospital

Recruiting

Williamsport, Pennsylvania, United States, 17754

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Dan P. Zandberg

UPMC Memorial

Recruiting

York, Pennsylvania, United States, 17408

Contacts

Site Public Contact

717-724-6760

Principal Investigator:

Dan P. Zandberg

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321hcc-clinical-trials@musc.edu

Principal Investigator:

John M. Kaczmar

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Site Public Contact

605-312-3320OncologyClinicTrialsSF@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Site Public Contact

605-312-3320OncologyClinicalTrialsSF@SanfordHealth.org

Principal Investigator:

Daniel Almquist

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Jennifer H. Choe

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Kathleen C. Kerrigan

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Erin R. Alesi

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Cristina P. Rodriguez

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Stuart J. Wong

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

ProHealth D N Greenwald Center

Recruiting

Mukwonago, Wisconsin, United States, 53149

Contacts

Site Public Contact

research.institute@phci.org

Principal Investigator:

Timothy R. Wassenaar

ProHealth Oconomowoc Memorial Hospital

Recruiting

Oconomowoc, Wisconsin, United States, 53066

Contacts

Site Public Contact

262-928-7878

Principal Investigator:

Timothy R. Wassenaar

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

UW Cancer Center at ProHealth Care

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-5539Chanda.miller@phci.org

Principal Investigator:

Timothy R. Wassenaar

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Seth O. Fagbemi

More Information

Sponsor

NRG Oncology

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-08-17.