Trial Title:
Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)
NCT ID:
NCT06400238
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (copanlisib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (copanlisib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (copanlisib)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Copanlisib
Description:
Given IV
Arm group label:
Treatment (copanlisib)
Other name:
BAY 80 6946
Other name:
BAY 80-6946
Other name:
BAY 806946
Other name:
BAY-80-6946
Other name:
BAY806946
Other name:
PI3K Inhibitor BAY 80-6946
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (copanlisib)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Summary:
This phase II MATCH treatment trial tests how well copanlisib works in treating patients
with cancer that has certain genetic changes. Copanlisib is used in patients whose cancer
has a mutated (changed) form of a gene called PTEN. It is in a class of medications
called kinase inhibitors. It works by blocking the action of an abnormal protein that
signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
Detailed 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:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
- 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
- Absoulute 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
June 19, 2018
Completion date:
May 15, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06400238
