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

  • STATUS
    Recruiting
  • participants needed
    6452
  • sponsor
    National Cancer Institute (NCI)
Updated on 22 November 2020
Investigator
Steven K. Bergstrom
Primary Contact
Kaiser Permanente-Walnut Creek (0.7 mi away) Contact
+966 other location
ct scan
platelet count
gonadotropin
cancer
combinations
corticosteroids
remission
total bilirubin
tubal ligation
hysterectomy
immunodeficiency
lymphoma
multiple myeloma
dasatinib
absolute neutrophil count
metastatic disease
antiretroviral
sunitinib
heart failure
prednisone
systemic therapy
serum pregnancy test
human immunodeficiency virus
measurable disease
HIV Infection
antiretroviral therapy
tenofovir
dolutegravir
skin cancer
cutaneous squamous cell carcinoma
oophorectomy
potassium
treatment regimen
bilateral oophorectomy
bone marrow procedure
gilbert's syndrome
adrenaline
corticosteroid
major surgery
white blood cells
metastasis
neutrophil count
pertuzumab
liver metastasis
immunohistochemistry
tumor cells
other malignancy
carcinoma in situ
brain metastases
chemotherapy regimen
biomarker analysis
brain metastasis
trastuzumab
luteinizing hormone
amend
afatinib dimaleate
nivolumab
cancer treatment
gonadotropin releasing hormone
solid tumors
cancer chemotherapy
glioblastoma multiforme
brain tumor
solid tumour
solid tumor
alopecia
targeted therapy
gnrh
afatinib
palbociclib
capivasertib
copanlisib
sapanisertib
taselisib
trametinib
antiretrovirals
protease inhibitor
other cancer
metastatic cancer
primary brain tumors
binimetinib
adavosertib
vismodegib
lhrh
palliative radiation therapy
mammogram
crizotinib
cytology specimen collection procedure
screening method
ipatasertib
sunitinib malate
dabrafenib
hypomagnesemia
osimertinib
pi3k-beta inhibitor gsk2636771
erdafitinib
fgfr inhibitor
larotrectinib
ulixertinib
fgfr inhibitor azd4547

Summary

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.

Description

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE

STEP 0 (Screening): Patients undergo biopsy along with molecular characterization of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo collection of blood samples for research purposes.

STEPS 1, 3, 5, 7 (Treatment): Patients are assigned to 1 of 37 treatment subprotocols based on molecularly-defined subgroup. (See Arms Section)

STEPS 2, 4, 6 (Screening): Patients experiencing disease progression on the prior Step treatment or who could not tolerate the assigned treatment undergo review of their previous biopsy results to determine if another treatment is available or undergo another biopsy. Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy.

STEP 8 (Optional Research): Consenting patients undergo end-of-treatment biopsy and collection of blood samples for research purposes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

Details
Treatment laboratory biomarker analysis, cytology specimen collection procedure, Trastuzumab, Afatinib, Nivolumab, sunitinib malate, dasatinib, Pertuzumab, Trastuzumab Emtansine, Palbociclib, Vismodegib, Crizotinib, Dabrafenib, Trametinib, Taselisib, Binimetinib, Copanlisib, Erdafitinib, Defactinib, Osimertinib, Ipatasertib, WEE1 Inhibitor AZD1775, Larotrectinib, afatinib dimaleate, Sapanisertib, Capivasertib, FGFR Inhibitor AZD4547, PI3K-beta Inhibitor GSK2636771, Adavosertib, Ulixertinib, Larotrectinib Sulfate, Copanlisib Hydrochloride, Dabrafenib Mesylate, Defactinib Hydrochloride
Clinical Study IdentifierNCT02465060
SponsorNational Cancer Institute (NCI)
Last Modified on22 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or Glioma or Malignant neoplasm of kidney or Prostate Cancer or Pancreatic Cancer or Advanced Malignant Solid Neoplasm or Recurrent ...?
Do you have any of these conditions: Recurrent Pancreatic Cancer or Recurrent Bladder Carcinoma or Advanced Solid Tumor or Malignant neoplasm of kidney or Prostate Cancer or Renal Cell Ca...?
Do you have any of these conditions: Recurrent Breast Cancer or Recurrent Bladder Cancer or Refractory Malignant Solid Neoplasm or Recurrent Pancreatic Cancer or carcinoma of the cervix u...?
Do you have any of these conditions: cancer of the pancreas or Recurrent Malignant Solid Neoplasm or Kidney Cancer or Carcinoma of the Head and Neck or ovarian epithelial carcinoma or rec...?
ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)
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 the criteria below and have received results from one of the designated outside laboratories indicating a "rare variant" that is an actionable Mutation of Interest (aMOI) for specific select subprotocols
The following requirements apply
The outside laboratory specifically notified the site that patient may be a potential candidate for MATCH due to a detected "rare variant"; the outside lab reports are NOT sufficient for this purpose
NOTE: The content and format of these specific notifications for the Outside Assay process will vary depending on the designated outside lab in question, as they are each responsible for their own outreach efforts; it is strongly recommended that the designated outside laboratory be contacted to confirm the format and receipt of this notification prior to registering any patients to Step 0
Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following notification of treatment assignment
NOTE: The receipt of this notification (and the start of the associated deadline for Step 1 registration) may occur shortly after Step 0 registration, since these patients will not be submitting tissue for screening purposes; however, for certain "rare variant" arms, submission of archival tissue for central immunohistochemistry (IHC) testing may be required
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
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
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
NOTE: Other potential aMOIs that would be eligibility criteria for "NON RARE" arms, as determined by the designated laboratories, are not applicable for this process in 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
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
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: For patients entering the study via the original screening process, 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 only intervening treatment permitted is prior therapy that the patient already received prior to Step 0 registration; 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; 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: e.g. 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
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 (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
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
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
As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
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
ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1)
If patients have been biopsied or submitted archived tumor tissue obtained within the last 6 months for assessment with the MATCH assays, patients may receive non-protocol treatment after biopsy/tissue submission (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; for patients entering step 0 with assay results from outside laboratories, no systemic treatment is allowed after step 0 registration; the decision to stop the intervening nonprotocol treatment will be left up to the treating physician if patient has an aMOI; waiting periods as described will apply
As MATCH is designed to add additional subprotocols, implement limited expansions of accrual for certain subprotocols, and/or amend existing arm-specific eligibility criteria, some patients entering under the original screening method may be eligible to have their results rerun in MATCHbox, even if they did not match to a treatment initially or did not receive a treatment assignment due to a lack of available assignment slots; patients whose sequence results will be rerun through MATCHbox must also meet the following criteria
Samples must have been collected within 5 months of the activation of the addendum, as there is an additional month needed to get the patients on trial
Patient has not had treatment within the 5 months that resulted in a PR or better after the performance of the screening assessment
Patient must meet eligibility criteria, including performance status 1 or better and life expectancy of at least 3 months
Patients must meet the eligibility requirements with the following exceptions
Patients may have received other non-targeted, immunotherapy or targeted treatment, which could be stopped in favor of returning to MATCH, if no response to the interim treatment has occurred and no further benefit is expected from this interim treatment, per the treating physician's discretion; documentation o
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ct scan
platelet count
gonadotropin
cancer
combinations
corticosteroids
remission
total bilirubin
tubal ligation
hysterectomy
immunodeficiency
lymphoma
multiple myeloma
dasatinib
absolute neutrophil count
metastatic disease
antiretroviral
sunitinib
heart failure
prednisone
systemic therapy
serum pregnancy test
human immunodeficiency virus
measurable disease
HIV Infection
antiretroviral therapy
tenofovir
dolutegravir
skin cancer
cutaneous squamous cell carcinoma
oophorectomy
potassium
treatment regimen
bilateral oophorectomy
bone marrow procedure
gilbert's syndrome
adrenaline
corticosteroid
major surgery
white blood cells
metastasis
neutrophil count
pertuzumab
liver metastasis
immunohistochemistry
tumor cells
other malignancy
carcinoma in situ
brain metastases
chemotherapy regimen
biomarker analysis
brain metastasis
trastuzumab
luteinizing hormone
amend
afatinib dimaleate
nivolumab
cancer treatment
gonadotropin releasing hormone
solid tumors
cancer chemotherapy
glioblastoma multiforme
brain tumor
solid tumour
solid tumor
alopecia
targeted therapy
gnrh
afatinib
palbociclib
capivasertib
copanlisib
sapanisertib
taselisib
trametinib
antiretrovirals
protease inhibitor
other cancer
metastatic cancer
primary brain tumors
binimetinib
adavosertib
vismodegib
lhrh
palliative radiation therapy
mammogram
crizotinib
cytology specimen collection procedure
screening method
ipatasertib
sunitinib malate
dabrafenib
hypomagnesemia
osimertinib
pi3k-beta inhibitor gsk2636771
erdafitinib
fgfr inhibitor
larotrectinib
ulixertinib
fgfr inhibitor azd4547

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