Trial Outcomes & Findings for Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H) (NCT NCT06400238)

Last Updated: 2025-11-14

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

35 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

2025-11-14

Participant Flow

Subprotocol Z1H was activated on June 20, 2018. Thirty-five patients were enrolled between October 2018 and January 2020. All patients were enrolled through the outside laboratory.

The PTEN mutation status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Thirty-one out of the 35 outside lab patients had their samples centrally confirmed.

Participant milestones

Participant milestones
Measure	Treatment (Copanlisib) Patients receive copanlisib 60 mg 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.
Overall Study STARTED	35
Overall Study Started Protocol Therapy	33
Overall Study Eligible, Treated and Mutation Status Confirmed	29
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Copanlisib) Patients receive copanlisib 60 mg 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.
Overall Study Started Protocol Therapy	2
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Disease Progression	27
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	2

Baseline Characteristics

Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Copanlisib) n=29 Participants Patients receive copanlisib 60 mg 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.
Age, Continuous	59 years n=10 Participants
Sex: Female, Male Female	21 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	2 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	2 Participants n=10 Participants
Race (NIH/OMB) White	23 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=10 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	Treatment (Copanlisib) n=29 Participants Patients receive copanlisib 60 mg 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.
Objective Response Rate (ORR)	3.4 percentage of participants Interval 0.2 to 15.3

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	Treatment (Copanlisib) n=29 Participants Patients receive copanlisib 60 mg 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.
6-month Progression Free Survival (PFS)	15.4 percentage of participants Interval 6.1 to 28.7

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	Treatment (Copanlisib) n=29 Participants Patients receive copanlisib 60 mg 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.
Progression Free Survival	1.84 months Interval 1.77 to 2.07

Adverse Events

Treatment (Copanlisib)

Serious events: 16 serious events

Other events: 27 other events

Deaths: 31 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Copanlisib) n=33 participants at risk Patients receive copanlisib 60 mg 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.
General disorders Fatigue	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Skin and subcutaneous tissue disorders Skin ulceration	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Nausea	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Vomiting	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Infections and infestations Sepsis	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Infections and infestations Skin infection	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Lymphocyte count decreased	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hyponatremia	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hypophosphatemia	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Musculoskeletal and connective tissue disorders Soft tissue necrosis upper limb	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Vascular disorders Hypertension	18.2% 6/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Vascular disorders Thromboembolic event	3.0% 1/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).

Other adverse events

Other adverse events
Measure	Treatment (Copanlisib) n=33 participants at risk Patients receive copanlisib 60 mg 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.
Blood and lymphatic system disorders Anemia	24.2% 8/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
General disorders Chills	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
General disorders Fatigue	36.4% 12/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	12.1% 4/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Abdominal pain	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Constipation	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Diarrhea	30.3% 10/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Dry mouth	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Mucositis oral	27.3% 9/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Nausea	48.5% 16/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Oral dysesthesia	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Gastrointestinal disorders Vomiting	15.2% 5/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Infections and infestations Skin infection	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Injury, poisoning and procedural complications Fall	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Alanine aminotransferase increased	12.1% 4/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Alkaline phosphatase increased	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Aspartate aminotransferase increased	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Lymphocyte count decreased	12.1% 4/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Platelet count decreased	15.2% 5/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations Weight loss	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Investigations White blood cell decreased	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Anorexia	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hyperglycemia	39.4% 13/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hypoalbuminemia	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hypocalcemia	9.1% 3/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hypomagnesemia	18.2% 6/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Metabolism and nutrition disorders Hyponatremia	12.1% 4/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Nervous system disorders Dizziness	6.1% 2/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Nervous system disorders Headache	15.2% 5/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).
Vascular disorders Hypertension	18.2% 6/33 • 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. Thirty-three patients were included in the toxicity analysis (excluding 2 who did not receive treatment).

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