Trial Outcomes & Findings for Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) (NCT NCT05490771)

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 (ie, eligible, treated and PIK3CA mutation status confirmed) 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 30 months post registration

Results posted on

2025-11-14

Participant Flow

Subprotocol Z1F was activated on June 20, 2018. Thirty-five patients were enrolled between June 2018 and December 2018.

The PIK3CA mutations status was determined by a CLIA-approved assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed for 30 patients based on confirmation report as of August 1, 2019.

Participant milestones

Participant milestones
Measure	Treatment (Copanlisib) Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Overall Study STARTED	35
Overall Study Eligible	31
Overall Study Started Protocol Therapy	30
Overall Study Eligible and Treated	28
Overall Study Mutation Status Confirmed	30
Overall Study Eligible, Treated and Mutation Status Confirmed	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Copanlisib) Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Overall Study Disease progression	18
Overall Study Adverse Event	3
Overall Study Other complicating disease	1
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1
Overall Study Still on treatment	2
Overall Study Never start protocol therapy	5
Overall Study Ineligible	2

Baseline Characteristics

Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Copanlisib) n=25 Participants Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Age, Continuous	61 years n=10 Participants
Sex: Female, Male Female	16 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 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	0 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	21 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 30 months post registration

Population: Eligible, treated and PIK3CA mutation status confirmed

Outcome measures

Outcome measures
Measure	Treatment (Copanlisib) n=25 Participants Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Overall Response Rate (ORR)	16 percentage of participants Interval 6.0 to 33.0

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, from which 6-month PFS rate is determined

Population: Eligible, treated and PIK3CA 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 NeuroOncology 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=25 Participants Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
6-month Progression-Free Survival (PFS) Rate	38 percentage of participants Interval 22.0 to 53.0

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 PIK3CA 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=25 Participants Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Progression Free Survival (PFS)	3.4 months Interval 1.8 to 6.6

Adverse Events

Treatment (Copanlisib)

Serious events: 17 serious events

Other events: 27 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Copanlisib) n=30 participants at risk Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Mucositis oral	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Oral pain	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Vomiting	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Infections and infestations Meningitis	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Alkaline phosphatase increased	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Weight loss	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Dehydration	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Hyperglycemia	26.7% 8/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Hypoglycemia	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Hypophosphatemia	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Nervous system disorders Dizziness	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Nervous system disorders Syncope	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Renal and urinary disorders Acute kidney injury	3.3% 1/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Vascular disorders Hypertension	30.0% 9/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.

Other adverse events

Other adverse events
Measure	Treatment (Copanlisib) n=30 participants at risk Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Blood and lymphatic system disorders Anemia	23.3% 7/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
General disorders Edema limbs	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
General disorders Fatigue	40.0% 12/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
General disorders General disorders and administration site conditions - Other	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Skin and subcutaneous tissue disorders Pruritus	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	26.7% 8/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Abdominal pain	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Constipation	20.0% 6/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Diarrhea	36.7% 11/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Dry mouth	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Gastroesophageal reflux disease	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Mucositis oral	13.3% 4/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Nausea	33.3% 10/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Gastrointestinal disorders Vomiting	13.3% 4/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Alkaline phosphatase increased	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Lymphocyte count decreased	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Neutrophil count decreased	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Platelet count decreased	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations Weight loss	13.3% 4/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Investigations White blood cell decreased	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Anorexia	16.7% 5/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Dehydration	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Hyperglycemia	43.3% 13/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Hypocalcemia	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Metabolism and nutrition disorders Hypomagnesemia	10.0% 3/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, spe	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Nervous system disorders Dysgeusia	13.3% 4/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Nervous system disorders Headache	13.3% 4/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Eye disorders Blurred vision	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 2/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.
Vascular disorders Hypertension	20.0% 6/30 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 16176323012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60