Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K)
May 12, 2026 updated by: National Cancer Institute (NCI)
MATCH Treatment Subprotocol Z1K: Ipatasertib in Patients With Tumors With AKT Mutations
This phase II MATCH treatment trial tests how well ipatasertib works in treating patients with cancer that has certain genetic changes called AKT mutations.
Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors.
It may stop the growth of cancer cells and may kill them.
Study Overview
Status
Active, not recruiting
Conditions
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 ipatasertib orally (PO) once daily (QD) on days 1-28 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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19103
- ECOG-ACRIN Cancer Research Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 have an AKT mutation as determined via the MATCH Master Protocol
- Patients with breast cancer are excluded
- Patients with castration-resistant prostate cancer should maintain castrate levels of testosterone (i.e., with gonadotropin-releasing hormone (GnRH) agonists or through surgical castration). Patients are allowed to continue abiraterone acetate/prednisone with Ipatasertib if the patient just progressed on abiraterone acetate/prednisone
- Patients must not have known hypersensitivity to Ipatasertib or compounds of similar chemical or biologic composition
- Patients with known KRAS, NRAS, HRAS, or BRAF mutations are not eligible for this protocol, as these mutations may lead to limited response due to resistance
Patients with diabetes or risk for hyperglycemia are eligible. Patients with diabetes mellitus should be on a stable dose of oral hypoglycemic agents for >= 4 weeks and appropriate diet. Patients with diabetes mellitus may enter the study unless any of the following exclusion criteria are fulfilled:
- Baseline fasting glucose value of > 8.9 mmol/L or 160 mg/dL (fasting is defined as no calorific intake for at least 8 hours)
- Patients not on a stable dose of oral hypoglycemic medication for >= 4 weeks and appropriate diet
- Insulin required for routine diabetic management and control
- More than two oral hypoglycemic medications required for routine diabetic management and control
- Glycosylated hemoglobin (hemoglobin A1C) >= 7.5%
- Prior PI3K and mTOR inhibitors are allowed, including in the metastatic setting. Prior AKT inhibitors are excluded
- Patients with a history of inflammatory bowel diseases (Crohn's disease and ulcerative colitis) or active diverticulitis are not eligible
- Patients may not have received strong inhibitors or potent inducers or substrates of CYP3A4/5 within 2 weeks before the first dose of study treatment (3 weeks for St John's wort)
- In addition to the patient contraception requirements outlined in EAY131 MATCH Master Protocol, male patients must also refrain from donating sperm for the duration of study participation, and for 4 months after completion of study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment (ipatasertib)
Patients receive ipatasertib 400 mg PO QD on days 1-28 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.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo CT scan
Other Names:
Undergo biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate (ORR)
Time Frame: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients.
Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.
Details about how to define complete response and partial response can be found in the master protocol.
90% two-sided binomial exact confidence interval is calculated for ORR.
|
Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival
Time Frame: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first.
Median PFS was estimated using the Kaplan-Meier method.
Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.
Please refer to the protocol for detailed definitions of disease progression.
|
Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
|
6-month Progression Free Survival (PFS)
Time Frame: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
|
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first.
Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.
Please refer to the protocol for detailed definitions of disease progression.
6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
|
Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin M Kalinsky, ECOG-ACRIN Cancer Research Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2019
Primary Completion (Actual)
June 27, 2023
Study Completion (Estimated)
January 15, 2027
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 3, 2024
First Posted (Actual)
May 6, 2024
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Hemic and Lymphatic Diseases
- Lymphoma
- Multiple Myeloma
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Biopsy
- Specimen Handling
- Magnetic Resonance Spectroscopy
- ipatasertib
Other Study ID Numbers
- NCI-2024-01194 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180820 (U.S. NIH Grant/Contract)
- EAY131-Z1K (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
NCI is committed to sharing data in accordance with NIH policy.
For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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