Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma
Intervention: Trastuzumab Emtansine
Intervention description: Given IV
Intervention MeSH terms: Trastuzumab; Ado-Trastuzumab Emtansine; Maytansine; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II MATCH treatment trial identifies the effects of ado-trastuzumab emtansine in
      patients whose cancer has a genetic change called HER2 amplification. Ado-trastuzumab
      emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called
      DM1. 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 and
      delivers DM1 to kill them. Researchers hope to learn if the study drug will shrink this type
      of cancer or stop its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients' tumor sample must have HER2 amplification > 7 based on targeted custom
             Ampliseq panel on the Ion Torrent Personal Genome Machine (PGM)

          -  Hemoglobin >= 9.0 g/dL (which may be reached by transfusion)

          -  Patients will be allowed if on anticoagulation (except warfarin and other coumarin
             derivatives) or on aspirin 81 mg by mouth daily. Additional monitoring while on
             anticoagulation will be based on institutional guidelines and/or physician discretion.
             However, patients will not be allowed if on long acting anti-platelet agents such as
             clopidogrel

          -  Patients must have an electrocardiogram (ECG) within 4 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

          -  Patients must have echocardiography (ECHO) or nuclear study (multigated acquisition
             scan [MUGA] or First Pass) within 4 weeks prior to registration to treatment and must
             not have a left ventricular ejection fraction (LVEF) < 50% to be eligible

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and for 7 months after completion of study

        Exclusion Criteria:

          -  Patients with a diagnosis of breast cancer or gastric/gastroesophageal junction (GEJ)
             cancer will be excluded

          -  Patients must not have known hypersensitivity to ado-trastuzumab emtansine or
             compounds of similar chemical or biologic composition

          -  Patients with current peripheral neuropathy of grade 3 or greater (National Cancer
             Institute [NCI]-Common Toxicity Criteria [CTC], version 4.0) will be excluded

               -  Neuropathy assessment and grade assignment will be based on history (location,
                  duration, balance and gait, effect on activity of daily living [ADLs]) and
                  physical exam

          -  Patient must not have had any of the prior therapies:

               -  Food and Drug Administration (FDA) approved:

                    -  Trastuzumab

                    -  Pertuzumab

                    -  Ado-trastuzumab emtansine

               -  Investigational:

                    -  Margetuximab

                    -  PF-05280014 (Pfizer, Trastuzumab Biosimilar)

                    -  CT-P6 (Celltrion, Trastuzumab Biosimilar)

                    -  ABP-980 (Amgen, Trastuzumab Biosimilar)