Malignant Solid NeoplasmPhase 2NCT06136897

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J)

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Echocardiography Test in people with Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Solid Neoplasm
What is being tested?: Biopsy Procedure, Biospecimen Collection and Echocardiography Test
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2017to 15 Jan 2027
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 outlined the MATCH Master Protocol at the time of registration to treatment step (step 1, 3, 5, 7)
Patients must have HER2 amplification, or another aberration, as determined via the MATCH Master Protocol
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 have ECHO or multigated acquisition scan (MUGA) within 4 weeks prior to treatment assignment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be >= 50% for the patient to be eligible
Patients must not have breast cancer, gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma or mixed histology, gastric/GEJ not otherwise specified (NOS) tumors, or colorectal adenocarcinoma

Show all 9Show fewer

Patients must not have known hypersensitivity to trastuzumab or pertuzumab or compounds of similar chemical or biologic composition
Patients must not have received prior anti-HER2 therapies, including trastuzumab, pertuzumab, trastuzumab emtansine (T-DM1), lapatinib, afatinib, neratinib, dacomitinib, canertinib
Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use adequate contraception (hormonal or double barrier method of birth control, abstinence) from one week prior to study treatment starting, during treatment, and for a period of 7 months after the last dose of study treatment

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: MATCH Treatment Subprotocol J: Trastuzumab and Pertuzumab (HP) in Patients With Non-Breast, Non-Gastric/GEJ, and Non-Colorectal Cancers With HER2 Amplification

This phase II MATCH treatment trial tests how well trastuzumab and pertuzumab work in treating patients with HER2-amplified non-breast, non-gastric/gastroesophageal junction, and non-colorectal cancers. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Trastuzumab is approved for the treatment of certain types of HER2-amplified cancers such as breast and gastric cancers. Research has shown that treatment with two anti-HER2 therapies in combination may be more effective at treating HER2-positive patients than giving one anti-HER2 therapy alone. Giving trastuzumab and pertuzumab in combination may be effective at treating patients with HER2-amplified cancers that aren't breast, gastric, or colorectal.

Read the detailed description

PRIMARY OBJECTIVE:

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:

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 pertuzumab intravenously (IV) over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, echocardiography (ECHO) at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.

After completion of study treatment, patients are followed up 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.

Conditions: Malignant Solid Neoplasm
Being tested: Biopsy Procedure, Biospecimen Collection, Echocardiography Test, Pertuzumab, Radiologic Examination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
PertuzumabBiological
Also called 2C4, 2C4 Antibody, BCD-178, EG1206A
Given IV
Radiologic ExaminationProcedure or surgery
Also called Radiologic Evaluation, Radiologic Exam
Undergo radiologic evaluation
TrastuzumabBiological
Also called ABP 980, ALT02, Biceltis, CANMab
Given IV

Study groups in NCT06136897
Study group	Role	What they receive
Treatment (pertuzumab, trastuzumab)	Experimental	Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Echocardiography Test; Biological: Pertuzumab; Procedure: Radiologic Examination; Biological: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate
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.
Measured: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Secondary outcomes (2)

6-month Progression-Free Survival (PFS) Rate
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.
Measured: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration
Progression Free Survival
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.
Measured: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 201715 Jan 2027

First posted18 Nov 2023
Study start23 Mar 2017
Primary completion3 Nov 2021
Study completion15 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06136897
Sponsor's protocol ID: NCI-2023-09506
Other IDs: NCI-2023-09506, EAY131-J, EAY131-J, U10CA180820
Status last verified: May 2026
First submitted: 15 Nov 2023
Last updated: 30 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: "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."

Publications

Connolly RM, Wang V, Hyman DM, Grivas P, Mitchell EP, Wright JJ, Sharon E, Gray RJ, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Wang J, Wisinski KB, Tricoli JV, Conley BA, Harris LN, Arteaga CL, O'Dwyer PJ, Chen AP, Flaherty KT. Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol J. Clin Cancer Res. 2024 Apr 1;30(7):1273-1280. doi: 10.1158/1078-0432.CCR-23-0633.
PubMed 38433347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Solid Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MATCH Treatment Subprotocol J: Trastuzumab and Pertuzumab (HP) in Patients With Non-Breast, Non-Gastric/GEJ, and Non-Colorectal Cancers With HER2 Amplification
ClinicalTrials.gov ID: NCT06136897
Acronym / sponsor ID: NCI-2023-09506
Conditions: Malignant Solid Neoplasm
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 35 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 23 Mar 2017 (actual)
Primary completion: 3 Nov 2021 (actual)
Study completion: 15 Jan 2027 (estimated)
First posted: 18 Nov 2023 (actual)
Results: Posted 25 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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:

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.

OUTLINE:

After completion of study treatment, patients are followed up 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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (pertuzumab, trastuzumab)	Experimental	Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Echocardiography Test, Biological: Pertuzumab, Procedure: Radiologic Examination, Biological: TrastuzumabPatients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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 outlined the MATCH Master Protocol at the time of registration to treatment step (step 1, 3, 5, 7)
Patients must have HER2 amplification, or another aberration, as determined via the MATCH Master Protocol
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 have ECHO or multigated acquisition scan (MUGA) within 4 weeks prior to treatment assignment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be >= 50% for the patient to be eligible

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy	Procedure or surgery	Treatment (pertuzumab, trastuzumab)
Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood samples	Procedure or surgery	Treatment (pertuzumab, trastuzumab)
Echocardiography TestAlso: EC, EchocardiographyUndergo ECHO	Procedure or surgery	Treatment (pertuzumab, trastuzumab)
PertuzumabAlso: 2C4, 2C4 Antibody, BCD-178, EG1206AGiven IV	Biological	Treatment (pertuzumab, trastuzumab)
Radiologic ExaminationAlso: Radiologic Evaluation, Radiologic ExamUndergo radiologic evaluation	Procedure or surgery	Treatment (pertuzumab, trastuzumab)
TrastuzumabAlso: ABP 980, ALT02, Biceltis, CANMabGiven IV	Biological	Treatment (pertuzumab, trastuzumab)

Primary outcome

Objective Response Rate
Time frame: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 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.

2 secondary outcomes

6-month Progression-Free Survival (PFS) Rate
Time frame: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration
Progression Free Survival
Time frame: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Results and safety

Results posted to the registry on 25 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Pertuzumab, Trastuzumab)	35	0

Primary outcome: Objective Response Rate

Time frame: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Treatment (Pertuzumab, Trastuzumab) n = 25
Value	12 (3.4 to 28.2)

Population analysed: Eligible, treated and mutation status confirmed

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Pertuzumab, Trastuzumab)	9 of 35 (25.7%)	27 of 35 (77.1%)	27 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38433347Connolly RM, Wang V, Hyman DM, Grivas P, Mitchell EP, Wright JJ, Sharon E, Gray RJ, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Wang J, Wisinski KB, Tricoli JV, Conley BA, Harris LN, Arteaga CL, O'Dwyer PJ, Chen AP, Flaherty KT. Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol J. Clin Cancer Res. 2024 Apr 1;30(7):1273-1280. doi: 10.1158/1078-0432.CCR-23-0633.
Individual participant dataSharing planned: Yes. "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."

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roisin M Connolly principal investigator

ECOG-ACRIN Cancer Research Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Echocardiography Test in people with Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.