August 1, 2022 Genomic Based Trial

Protocol: ECOG – EAY131-Z1M

SCHEMA ECOG EAY131 Z1M

Please Note: Below is brief eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  1. Patients must fulfill all eligibility criteria MATCH Master Protocol.
  2. Patients must have mismatch repair deficiency based on one of the following: 1. Mismatch repair testing done in any laboratory under CLIA conditions with IHC for MLH1/MSH2 +/-MSH6 +/-PMS2 OR 2. PCR-based microsatellite testing using a validated assay done in any laboratory under CLIA conditions OR 3. A MATCH designated laboratory determination of MMR status by DNA sequencing.
  3. Patients must have LAG-3 expression at ≥1%.
  4. Patients with active melanoma are ineligible.
  5. Patients must have an electrocardiogram (ECG) within 8 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).
  6. Patients must have Troponin T (TnT) or I (TnI) <2 x ULN. Patients with TnT or TnI levels between >1 to 2 x ULN will be allowed to register if repeat levels within 24 hours are ≤ 1 x ULN. If TnT or TnI levels are >1 to 2 x ULN within 24 hours, the patients may undergo a cardiac evaluation and be considered for treatment. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 x ULN, the patient may undergo cardiac evaluation and be considered for treatment.
  7. Patients must not have known hypersensitivity to nivolumab and BMS-986016 or compounds of similar chemical or biologic composition.
  8. Patients must not have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration. Use of such agents while on study is also prohibited. Prior use of growth factors should be documented in the patient’s medical history.
  9. Patients must not be on supplemental home oxygen.
  10. Patients must not have prior treatment with anti-LAG3 inhibitors.
  11. Patients must not have evidence of interstitial lung disease.
  12. Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients will be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement
    doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.


August 1, 2022 Genomic Based Trial

Protocol: EAY131-H

SCHEMA ECOG EAY131 H

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  1. Patients must have a BRAF V600E or, V600K, V600R or V600D mutation, or another aberration, as identified via the MATCH Master Protocol.
  2. Patients must fulfill all eligibility criteria in the MATCH Master Protocol.
  3. Patients with a diagnosis of metastatic melanoma from a cutaneous, acral, mucosal, or unknown primary site are excluded.
  4. Patients with a diagnosis of papillary thyroid cancer are excluded.
  5. Patients with a diagnosis of non-small cell lung cancer are excluded.
  6. Patients with a diagnosis of cholangiocarcinoma are excluded.
  7. Patients with a diagnosis of low grade serous ovarian cancer are excluded.
  8. Patients must have an ECHO or a nuclear study (MUGA or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < the institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible.
  9. Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment.
  10. Patients with prior exposure to dabrafenib or trametinib on another treatment subprotocol of the MATCH trial are excluded.
  11. Patients who previously received monoclonal antibody therapy (eg. Ipilimumab and others) must have stopped the prior therapy for 8 or more weeks before starting on trametinib and dabrafenib.


April 9, 2020 Genomic Based Trial

PROTOCOL: TAPUR

SCHEMA TAPUR

Please Note: Below is partial eligibility,  for full eligibility requirements, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

ELIGIBILITY:

  1. Patient (age ≥ 12 years*) with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated.
  2. ECOG performance status 0-2.
  3. Patients must have measurable or evaluable disease.
  4. Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression.
    1. Note: Eligible genomic tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS), whole exome sequencing (WES). The test may have been performed on a fresh or paraffin-embedded specimen of the primary tumor or a metastatic deposit or on cell free DNA derived from plasma, as determined by the treating physician, and must reveal a potentially actionable genomic variant as defined in Section 5.0, or protein overexpression by IHC.
  5. Have a tumor genomic profile for which treatment with one of the FDA approved targeted anti-cancer therapies included in this study has potential clinical benefit.
  6. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment (start of study treatment).
  7. Patients with new or progressive brain metastases (active brain metastases) 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 study treatment.
  8. Patients with prior brain radiation will also be eligible provided that there are new or residual, non-irradiated measurable brain lesions. If the lesions are previously radiated, those must demonstrate unequivocal progression of disease in the opinion of the treating physician.
  9. Have completed brain surgery or radiation ≥ 14 days prior to initiating the study treatment and recovered from all acute effects and not anticipated to require urgent brain surgery or radiation for symptomatic progression as assessed by the treating physician.


April 9, 2020 Genomic Based Trial

Protocol – ECOG – EAY131 (MATCH)

SCHEMA ECOG EAY131

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-762-8079 and/or (810) 762-8038. Thank you!

ELIGIBILITY:

 

  1. Patients must be ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of study investigational
    agents in patients < 18 years of age, children are excluded from this study.
  2. 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:

    1. Patients must have progressed following at least one line of standard systemic therapy and there must not be other
      approved/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
    2. 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:
      a) adequately treated basal cell or squamous cell skin cancer
      b) in situ cervical cancer
      c) adequately treated Stage I or II cancer from which the patient is currently in complete remission
      d) any other cancer from which the patient has been disease-free for 5 years.
  3. Patients must have measurable disease.
  4. 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.
  5. There is no particular window of time after notification of potential eligibility from an outside lab in which the patient must be
    registered to Step 0, but treatment slots will be assigned on a first come, first serve basis to those who do register to Step 0, and are
    not held for those notified of potential eligibility who do not register to Step 0.
  6. Patients may have received other non-targeted, immunotherapy or targeted treatment between the prior genetic testing at the outside
    lab and registration to Step 0. The decision to stop such treatment in favor of participation in MATCH, if no further clinical benefit is
    expected, is per the treating physician’s discretion. Documentation of a lack of response to the prior treatment is not required in these
    cases.
  7. Patients must have ECOG performance status ≤ 1 and a life expectancy of at least 3 months.
  8. Patients must not currently be receiving any other investigational agents.
  9. Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy ≥ 4 weeks prior to start of treatment.
  10. PLEASE NOTE: IT IS ESTIMATED TO TAKE 6-8 WEEKS TO BE ASSIGNED TO A TREATMENT ON THIS TRIAL.

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