Trial Search Results

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Adavosertib
  • Drug: Afatinib
  • Drug: Binimetinib
  • Drug: Capivasertib
  • Drug: Crizotinib
  • Other: Cytology Specimen Collection Procedure
  • Drug: Dabrafenib
  • Drug: Dasatinib
  • Drug: Defactinib
  • Drug: FGFR Inhibitor AZD4547
  • Other: Laboratory Biomarker Analysis
  • Drug: Larotrectinib
  • Biological: Nivolumab
  • Drug: Osimertinib
  • Drug: Palbociclib
  • Biological: Pertuzumab
  • Drug: PI3K-beta Inhibitor GSK2636771
  • Drug: Sapanisertib
  • Drug: Sunitinib Malate
  • Drug: Taselisib
  • Drug: Trametinib
  • Biological: Trastuzumab
  • Biological: Trastuzumab Emtansine
  • Drug: Vismodegib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Women of childbearing potential must have a negative serum pregnancy test within 2
   weeks prior to registration; patients that are pregnant or breast feeding are
   excluded; a female of childbearing potential is any woman, regardless of sexual
   orientation or whether they have undergone tubal ligation, who meets the following
   criteria:

      - Has not undergone a hysterectomy or bilateral oophorectomy; or

      - Has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
      has had menses at any time in the preceding 24 consecutive months)

   - 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 4 months after completion of study;
   should a woman become pregnant or suspect while she or her partner is participating in
   this study, she should inform her treating physician immediately

   - Patients must have histologically documented solid tumors or histologically confirmed
   diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the
   following criteria:

      - Patients must have progressed following at least one line of standard systemic
      therapy and there must not be other approval/standard therapy available that has
      been shown to prolong overall survival (i.e. in a randomized trial against
      another standard treatment or by comparison to historical controls); patients who
      cannot receive other standard therapy that has been shown to prolong overall
      survival due to medical issues will be eligible, if other eligibility criteria
      are met; if the patient is currently receiving therapy, the clinician must have
      assessed that the current therapy is no longer benefitting the patient prior to
      enrolling on MATCH, regardless of whether it is considered standard OR

      - Patients for whose disease no standard treatment exists that has been shown to
      prolong overall survival

      - NOTE: No other prior malignancy is allowed except for the following: adequately
      treated basal cell or squamous cell skin cancer; in situ cervical cancer;
      adequately treated stage I or II cancer from which the patient is currently in
      complete remission; any other cancer from which the patient has been disease-free
      for 5 years

   - Patients must have measurable disease

   - Patients must meet one of the following criteria:

      - Patients must have tumor amenable to image guided or direct vision biopsy and be
      willing and able to undergo a tumor biopsy for molecular profiling; patients with
      multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to
      obtain tumor cells; biopsy must not be considered to be more than minimal risk to
      the patient

         - NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after
         stopping prior therapy; there is no specific duration for which patients
         must be off treatment prior to registration to the relevant screening step
         (and subsequently, the biopsy), as long as all other eligibility criteria
         are met OR

      - Patient will be undergoing a procedure due to medical necessity during which the
      tissue may be collected

         - NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after
         stopping prior therapy; there is no specific duration for which patients
         must be off treatment prior to registration to the relevant screening step
         (and subsequently, the biopsy), as long as all other eligibility criteria
         are met OR

      - Formalin-fixed paraffin-embedded tumor tissue block(s) are available for
      submission following pre-registration (not applicable for bone marrow aspirate
      specimens); criteria for the submission of formalin-fixed paraffin-embedded
      (FFPE) tissue are:

         - Tissue must have been collected within 6 months prior to pre-registration to
         Step 0

            - Patient may receive treatment after tissue collection; however, lack of
            response must be documented prior to Step 1; the following restrictions
            apply:

               - Enrollment onto another investigational study is not permitted

               - Intervening therapy that constitutes a new, molecularly targeted
               therapy is not permitted; please note, immunotherapy is not
               considered molecularly targeted

                  - Continuation of an agent/regimen for which disease
                  progression has been observed prior to biopsy is permitted,
                  including targeted therapy

               - A new immunotherapy regimen is permitted; but, lack of response
               must also be documented prior to registration to Step 0

         - Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum
         requirements OR

      - Results from one of the designated outside laboratories indicate a "rare variant"
      that is an actionable mutation of interest (aMOI) for specific designated rare
      variant subprotocols; the following requirements apply:

         - The outside laboratory notified the site that patient may be a potential
         candidate for MATCH due to a detected "rare variant"

         - Patients with an applicable "rare variant" must be able to meet the
         eligibility criteria for the appropriate subprotocols within 4 weeks
         following entry on the EAY131 Step 0 screening step

         - Registration to Step 0 must occur after stopping prior systemic anti-cancer
         therapy; there is no specific duration for which patients must be off
         treatment prior to registration to Step 0, as long as all eligibility
         criteria are met

            - NOTE: Other potential aMOIs that would be eligibility criteria for NON
            RARE arms, as determined by the above laboratories, are not applicable
            for direct treatment assignment on MATCH

            - NOTE: Tumor tissue for the confirmation of "rare variant" by the MATCH
            assay is to be submitted, preferably from the same time of collection
            as that evaluated by the designated outside laboratory

   - Patient must not require the use of full dose coumarin-derivative anticoagulants such
   as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic
   use; factor X inhibitors are permitted

      - NOTE: Warfarin may not be started while enrolled in the EAY131 study

      - Stopping the anticoagulation for biopsy should be per site standard operating
      procedure (SOP)

   - Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1
   and a life expectancy of at least 3 months

   - Patients must not currently be receiving any other investigational agents

   - Patients must not have any uncontrolled intercurrent illness including, but not
   limited to:

      - Symptomatic congestive heart failure (New York Heart Association [NYHA]
      classification of III/IV)

      - Unstable angina pectoris or coronary angioplasty, or stenting within 6 months
      prior to registration to Step 0, 2, 4, 6

      - Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute
      [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade
      >= 2)

      - Psychiatric illness/social situations that would limit compliance with study
      requirements

      - Intra-cardiac defibrillators

      - Known cardiac metastases

      - Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram
      (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e.,
      mild regurgitation/stenosis] can be entered on study); subjects with moderate
      valvular thickening should not be entered on study

      - NOTE: To receive an agent, patient must not have any uncontrolled intercurrent
      illness such as ongoing or active infection; patients with infections unlikely to
      be resolved within 2 weeks following screening should not be considered for the
      trial

   - Patients must be able to swallow tablets or capsules; a patient with any
   gastrointestinal disease that would impair ability to swallow, retain, or absorb drug
   is not eligible

   - Patients who are human immunodeficiency virus (HIV)-positive are eligible if:

      - CD4+ cell count greater or equal to 250 cells/mm^3

      - If patient is on antiretroviral therapy, there must be minimal interactions or
      overlapping toxicity of the antiretroviral therapy with the experimental cancer
      treatment; for experimental cancer therapeutics with CYP3A/4 interactions,
      protease inhibitor therapy is disallowed; suggested regimens to replace protease
      inhibitor therapy include dolutegravir given with tenofovir/emtricitabine;
      raltegravir given with tenofovir and emtricitabine; once daily combinations that
      use pharmacologic boosters may not be used

      - No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining
      conditions other than historical low CD4+ cell counts

      - Probable long-term survival with HIV if cancer were not present

   - Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy]
   or less), or major surgery must have been completed >= 4 weeks prior to start of
   treatment; all adverse events due to prior therapy have resolved to a grade 1 or
   better (except alopecia and lymphopenia) by start of treatment; palliative radiation
   therapy must have been completed at least 2 weeks prior to start of treatment; the
   radiotherapy must not be to a lesion that is included as measurable disease

      - NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing
      hormone (LHRH) agonist

      - NOTE: Patients may receive non-protocol treatment after biopsy (if clinically
      indicated) until they receive notification of results; however, lack of response
      must be documented prior to registration to Step 1; new non-protocol treatment
      will NOT be permitted as intervening therapy after registration to Step 0; the
      decision to stop the intervening non-protocol treatment will be left up to the
      treating physician if patient has an aMOI; however, patients will need to be off
      such therapy for at least 4 weeks before receiving any MATCH protocol treatment

      - NOTE: For patients entering the study via a designated outside laboratory, no
      intervening systemic non-protocol treatment is permitted after Step 0
      registration; all other eligibility requirements still apply to these patients,
      including the washouts for prior therapy noted above in this section, the time
      restrictions outlined, and the eligibility criteria for the intended subprotocol

   - Patients with brain metastases or primary brain tumors must have completed treatment,
   surgery or radiation therapy >= 4 weeks prior to start of treatment

   - Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and
   remain off steroids thereafter, except as permitted (see below); patients with
   glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for
   one week prior to registration to treatment (Step 1, 3, 5, 7)

      - NOTE: The following steroids are permitted (low dose steroid use is defined as
      prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):

         - Temporary steroid use for computed tomography (CT) imaging in setting of
         contrast allergy

         - Low dose steroid use for appetite

         - Chronic inhaled steroid use

         - Steroid injections for joint disease

         - Stable dose of replacement steroid for adrenal insufficiency or low doses
         for non-malignant disease

         - Topical steroid

         - Steroids required to manage toxicity related to study treatment, as
         described in the subprotocols

         - Steroids required as pre- or post-chemotherapy medication for acceptable
         intervening chemotherapy

            - NOTE: Steroids must be completed alongside last dose of chemotherapy

   - Within 2 weeks prior to screening step registration and within 4 weeks prior to
   treatment step registration: Leukocytes >= 3,000/mcL

   - Within 2 weeks prior to screening step registration and within 4 weeks prior to
   treatment step registration: Absolute neutrophil count >= 1,500/mcL

   - Within 2 weeks prior to screening step registration and within 4 weeks prior to
   treatment step registration: Platelets >= 100,000/mcL

   - NOTE: Patients with documented bone marrow involvement by lymphoma are not required to
   meet the above hematologic parameters, but must have a platelet count of at least
   75,000/mcL and neutrophil count of at least 1,000/mcL

   - Within 2 weeks prior to screening step registration and within 4 weeks prior to
   treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of
   normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x
   institutional ULN is permitted)

   - Within 2 weeks prior to screening step registration and within 4 weeks prior to
   treatment step registration: Aspartate aminotransferase (AST) (serum glutamic
   oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate
   pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN (up to 5 times ULN in
   presence of liver metastases)

   - Within 2 weeks prior to screening step registration and within 4 weeks prior to
   treatment step registration: Creatinine clearance >= 45 mL/min/1.73 m^2 for patients
   with creatinine levels above institutional normal

   - Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to
   screening step and must meet the following cardiac criteria:

      - Resting corrected QT interval (QTc) =< 480 msec

         - NOTE: If the first recorded QTc exceeds 480 msec, two additional,
         consecutive ECGs are required and must result in a mean resting QTc =< 480
         msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks
         between the ECGs

      - The following only need to be assessed if the mean QTc > 480 msec

         - Check potassium and magnesium serum levels

         - Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG
         to confirm exclusion of patient due to QTc

         - For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual
         read of QTc is required

         - For patients with baseline HR < 60 or > 100 bpm, manual read of QT by
         trained personnel is required, with Fridericia correction applied to
         determine QTc

         - Patient must not have hypokalemia (value < institutional lower limit of
         normal)

      - No factors that increase the risk of QTc prolongation or risk of arrhythmic
      events such as heart failure, congenital long QT syndrome, family history of long
      QT syndrome or unexplained sudden death under 40 years of age or any concomitant
      medication known to prolong the QT interval

         - NOTE: Patient must be taken off prohibited medication prior to registration
         to the screening step (Step 0, 2, 4, 6) and remain off these medications
         thereafter, unless permitted on a subprotocol for the management of
         treatment related toxicity; patient must be off the drug for at least 5
         half-lives prior to registration to the treatment step (Step 1, 3, 5, 7);
         the medication half-life can be found in the package insert for Food and
         Drug Administration (FDA) approved drugs

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ginna Freehling
650-721-8899
Recruiting