BridgeMD
Compares treatment options for Metastatic Salivary Gland Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT05408845
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic salivary gland carcinoma.
Also referred to as Docecad, RP 56976.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cancer...
- 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...
- Note: HER2 evaluation based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local/commercial next-generation...
- Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines
You likely can't join if
- 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...
- 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
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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 =\ = 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- Pregnancy and individuals unwilling to discontinue nursing
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Irvine, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- San Leandro, California, United States
- San Rafael, California, United States
- Santa Clara, California, United States
- Santa Rosa, California, United States
- South San Francisco, California, United States
- Vallejo, California, United States
- Walnut Creek, California, United States
+ 110 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Dublin, California, United States; Fremont, California, United States; Fresno, California, United States; Irvine, California, United States and 124 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.