Trial Outcomes & Findings for Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) (NCT NCT06360588)

Last Updated: 2026-04-17

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

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

Results posted on

2026-04-17

Participant Flow

Subprotocol Z1G was activated on June 20, 2018. Twenty-two patients were enrolled between October 2018 and September 2021. All patients were enrolled through the outside laboratory.

The PTEN loss status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Twenty-one out of the 22 outside lab patients had their samples centrally confirmed.

Participant milestones

Participant milestones
Measure	Subprotocol Z1G (PTEN Loss) Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
Overall Study STARTED	22
Overall Study Started Protocol Therapy	22
Overall Study Eligible and Treated	21
Overall Study Eligible, Treated and Mutation Status Confirmed	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Subprotocol Z1G (PTEN Loss) Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
Overall Study Adverse Event	3
Overall Study Death	2
Overall Study Disease Progression	14
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1
Overall Study Ineligible	1

Baseline Characteristics

Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subprotocol Z1G (PTEN Loss) n=20 Participants Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
Age, Continuous	62 years n=130 Participants
Sex: Female, Male Female	14 Participants n=130 Participants
Sex: Female, Male Male	6 Participants n=130 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=130 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=130 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=130 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=130 Participants
Race (NIH/OMB) Asian	0 Participants n=130 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=130 Participants
Race (NIH/OMB) Black or African American	2 Participants n=130 Participants
Race (NIH/OMB) White	16 Participants n=130 Participants
Race (NIH/OMB) More than one race	1 Participants n=130 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=130 Participants

PRIMARY outcome

Timeframe: 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

Population: Eligible, treated and mutation status confirmed

Outcome measures

Outcome measures
Measure	Subprotocol Z1G (PTEN Loss) n=20 Participants Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
Objective Response Rate (ORR)	0 percentage of participants Interval 0.0 to 13.9

SECONDARY outcome

Timeframe: 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

Population: Eligible, treated and mutation status confirmed

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.

Outcome measures

Outcome measures
Measure	Subprotocol Z1G (PTEN Loss) n=20 Participants Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
6-month Progression-free Survival (PFS) Rate	17.5 percentage of participants Interval 6.0 to 34.0

SECONDARY outcome

Timeframe: 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

Population: Eligible, treated and mutation status confirmed

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.

Outcome measures

Outcome measures
Measure	Subprotocol Z1G (PTEN Loss) n=20 Participants Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
Progression Free Survival	1.8 months Interval 1.4 to 3.9

Adverse Events

Subprotocol Z1G (PTEN Loss)

Serious events: 7 serious events

Other events: 13 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Subprotocol Z1G (PTEN Loss) n=22 participants at risk Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
Investigations Lymphocyte count decreased	4.5% 1/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Metabolism and nutrition disorders Hyperglycemia	13.6% 3/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.5% 1/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Renal and urinary disorders Acute kidney injury	4.5% 1/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Vascular disorders Hypertension	9.1% 2/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Vascular disorders Thromboembolic event	4.5% 1/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.

Other adverse events

Other adverse events
Measure	Subprotocol Z1G (PTEN Loss) n=22 participants at risk Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.
General disorders Fatigue	31.8% 7/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Gastrointestinal disorders Diarrhea	18.2% 4/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Gastrointestinal disorders Nausea	36.4% 8/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Gastrointestinal disorders Vomiting	13.6% 3/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Investigations Lymphocyte count decreased	13.6% 3/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Metabolism and nutrition disorders Anorexia	18.2% 4/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Metabolism and nutrition disorders Hyperglycemia	27.3% 6/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Vascular disorders Hypertension	13.6% 3/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.
Blood and lymphatic system disorders Anemia	13.6% 3/22 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-two patients were included in the toxicity analysis.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60