Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan szolid daganatos betegeket keres, akiknek a daganata a közeli szövetekre vagy máshová is átterjedt. A betegségnek a standard kezelés mellett rosszabbodnia kellett, vagy nincs olyan standard kezelés, amely bizonyítottan meghosszabbítja az életet.

Életkor

18 éves vagy idősebb felnőttek, valamint 18 év alattiak is, ha van tárolt daganatszövet-mintájuk.

Nem

Mindkét nem részt vehet.

A betegség stádiuma

Helyileg előrehaladott vagy előrehaladott szolid daganat, amely kezelést igényel, és a betegség mérhető.

Korábbi kezelés

A betegségnek legalább egy sor standard szisztémás kezelés mellett előre kellett haladnia, vagy nincs olyan standard kezelés, amely bizonyítottan meghosszabbítja a teljes túlélést.

Biomarker vagy leletérték

Rendelkezésre kell állnia a daganat génszekvenálási eredményének egy NCI által akkreditált kijelölt laboratóriumból.

A részvétel fő kizáró okai

• Nincs mérhető betegség
• ECOG-állapot 2 felett, vagy Lansky- vagy Karnofsky-állapot 50% alatt
• Nincs szekvenálási eredmény NCI által akkreditált kijelölt laboratóriumból
• A beválasztó orvos szerint nem juthat be ComboMATCH kezelési vizsgálatba
• Nincs biopsziával elérhető daganat és nincs tárolt daganatszövet

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

A vizsgálat 20 csoportja

• EAY191-A2 (Cohort 1, Arm A)A vizsgált kezelés

  Cohort 1, Arm A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

  Kezelés: Alpelisib, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging, Olaparib és Positron Emission Tomography

• EAY191-A2 (Cohort 2, Arm B)A vizsgált kezelés

  Cohort 2, Arm B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

  Kezelés: Alpelisib, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging, Olaparib és Positron Emission Tomography

• EAY191-A2 (Cohort 2, Arm C)A vizsgált kezelés

  Cohort 2, Arm C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging, Olaparib és Positron Emission Tomography

• EAY191-A2 (Cohort 3, Arm D)A vizsgált kezelés

  Cohort 3, Arm D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

  Kezelés: Alpelisib, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Olaparib és Positron Emission Tomography

• EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib)A vizsgált kezelés

  Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging és Palbociclib

• EAY191-A3 Monotherapy Cohort 1 (binimetinib)A vizsgált kezelés

  Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

  Kezelés: Binimetinib, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography és Magnetic Resonance Imaging

• EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations)A vizsgált kezelés

  Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or a FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Echocardiography Test, Fluorouracil, Leucovorin, Magnetic Resonance Imaging, Multigated Acquisition Scan, Oxaliplatin és Positron Emission Tomography

• EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)A vizsgált kezelés

  Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated

  Kezelés: Binimetinib, Biospecimen Collection, Bone Scan, Computed Tomography, Echocardiography Test, Fluorouracil, Leucovorin, Magnetic Resonance Imaging, Multigated Acquisition Scan, Oxaliplatin és Positron Emission Tomography

• EAY191-E4 (taxane therapy)A vizsgált kezelés

  Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Nilotinib Hydrochloride Monohydrate és Paclitaxel

• EAY191-E5 Cohort I Arm A (sotorasib, panitumumab)A vizsgált kezelés

  Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Panitumumab és Sotorasib

• EAY191-E5 Cohort I Arm B (sotorasib)Már használt kezelés, összehasonlításként

  Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging és Sotorasib

• EAY191-E5 Cohort II (sotorasib)A vizsgált kezelés

  Patients receive combination therapy as in EAY191-E5 Arm A.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Panitumumab és Sotorasib

• EAY191-N2 Cohort I (Arm I) (NF1 mutations)A vizsgált kezelés

  Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.

  Kezelés: Binimetinib, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Echocardiography Test, Fulvestrant, Magnetic Resonance Imaging és Multigated Acquisition Scan

• EAY191-N2 Cohort I (Arm II) (NF1 mutations)A vizsgált kezelés

  Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Echocardiography Test, Fulvestrant, Magnetic Resonance Imaging és Multigated Acquisition Scan

• EAY191-N2 Cohort II (NF1 mutations)A vizsgált kezelés

  Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.

  Kezelés: Binimetinib, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Echocardiography Test, Fulvestrant, Magnetic Resonance Imaging és Multigated Acquisition Scan

• EAY191-N4 Arm I (RAS pathway mutations)A vizsgált kezelés

  Patients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Echocardiography Test, Multigated Acquisition Scan, Mutation Carrier Screening, Olaparib és Selumetinib Sulfate

• EAY191-N4 Arm II (RAS pathway mutations)Már használt kezelés, összehasonlításként

  Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Echocardiography Test, Multigated Acquisition Scan, Mutation Carrier Screening és Selumetinib Sulfate

• EAY191-N5 Arm I (neratinib maleate)Már használt kezelés, összehasonlításként

  Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan és Neratinib Maleate

• EAY191-N5 Arm II (neratinib maleate,palbociclib)A vizsgált kezelés

  Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Neratinib Maleate és Palbociclib

• EAY191-S3 (activating AKT mutation)A vizsgált kezelés

  Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.

  Kezelés: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Ipatasertib, Magnetic Resonance Imaging és Paclitaxel