Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)
NCT ID: NCT06400238
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2018-10-15
2025-12-31
Brief Summary
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Detailed Description
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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:
Patients receive copanlisib intravenously (IV) over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
THE MATCH SCREENING TRIAL:
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (copanlisib)
Patients receive copanlisib IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Copanlisib
Given IV
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Copanlisib
Given IV
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must fulfill all eligibility criteria of MATCH Master Protocol at the time of registration to treatment step (Step 1, 3, 5, 7)
* Patients must have mutations in the PTEN gene with 1% or more expression of PTEN by immunohistochemistry (IHC) as determined via the MATCH Master Protocol
* NOTE: For patients entering the study, all patients must have PTEN IHC performed as described in the MATCH Master Protocol. This includes patients entering the study via the outside assay process
* Patients must not have co-existing aberrations in the MAPK or PI3K/MTOR pathways as determined by the MATCH screening assessment in NRAS, HRAS, KRAS, BRAF, PIK3CA, AKT or mTOR
* 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)
* Patients must not have known hypersensitivity to copanlisib or compounds of similar chemical or biologic composition
* Patients must not have had prior treatment with copanlisib or other PI3K inhibitors, AKT inhibitors or mTOR inhibitors
* Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior to start of study treatment and for the duration of study treatment
* Patients should stop using herbal medications at least 7 days prior to the first dose of copanlisib. Herbal medications include, but are not limited to: St. John's wort, kava, ephedra, gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng
* Patients with type I or II diabetes mellitus must have a glycosylated hemoglobin (HbA1c) ≤ 8.5% within 28 days from registration
* Patients must not have uncontrolled hypertension defined as systolic blood pressure (SBP) greater than 160 mmHg or diastolic blood pressure (BP) greater than 100 mmHg or use of more than 2 anti-hypertensive medications
* Patients must not have HER2 positive (3+ by IHC or fluorescence in situ hybridization \[FISH\] ratio ≥ 2) breast cancer
* Patients must not have indolent NHL (non-Hodgkin's lymphoma) or DLBCL (diffuse large B cell lymphoma) because other studies are ongoing with this agent in this group of patients
* Patients must not be on anti-arrhythmic therapy other than digoxin or beta-blockers
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 /L
* Platelets ≥ 100 x10\^9 /L
* Hemoglobin (Hb) \> 9 g/dl
* Total serum bilirubin \< 2.0 mg/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5x upper limit of normal (ULN) (\< 5 x ULN in patients with liver metastases)
* Serum creatinine \< 1.5 x ULN
* Patients with non-healing wound, ulcer, or bone fracture are not eligible
* Patients with history of or current interstitial pneumonitis are not eligible
* NOTE: For solid tumors, cytomegalovirus (CMV) polymerase chain reaction (PCR) can be obtained at the discretion of treating physician or local institutional guidelines
* Men and women of child-bearing potential must agree to use contraception while receiving study treatment and for 1 month after the last dose of copanlisib
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Filip Janku
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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NCI-2024-01162
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAY131-Z1H
Identifier Type: OTHER
Identifier Source: secondary_id
EAY131-Z1H
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-01162
Identifier Type: -
Identifier Source: org_study_id