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

NCT ID: NCT06136897

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2025-12-31

Brief Summary

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.

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (pertuzumab, trastuzumab)

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.

Group Type: EXPERIMENTAL

Biopsy Procedure

Intervention Type: PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

Echocardiography Test

Intervention Type: PROCEDURE

Undergo ECHO

Pertuzumab

Intervention Type: BIOLOGICAL

Given IV

Radiologic Examination

Intervention Type: PROCEDURE

Undergo radiologic evaluation

Trastuzumab

Intervention Type: BIOLOGICAL

Given IV

Interventions

Biopsy Procedure

Undergo biopsy

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

Intervention Type: PROCEDURE

Echocardiography Test

Undergo ECHO

Intervention Type: PROCEDURE

Pertuzumab

Given IV

Intervention Type: BIOLOGICAL

Radiologic Examination

Undergo radiologic evaluation

Intervention Type: PROCEDURE

Trastuzumab

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

Biopsy; BIOPSY_TYPE; Bx; Biological Sample Collection; Biospecimen Collected; Specimen Collection; EC; Echocardiography; 2C4; 2C4 Antibody; BCD-178; EG1206A; HLX11; HS627; MoAb 2C4; Monoclonal Antibody 2C4; Omnitarg; Perjeta; Pertuzumab Biosimilar BCD-178; Pertuzumab Biosimilar EG1206A; Pertuzumab Biosimilar HLX11; Pertuzumab Biosimilar HS627; Pertuzumab Biosimilar TQB2440; Rhumab 2C4; rhuMAb2C4; RO4368451; TQB 2440; TQB-2440; TQB2440; Radiologic Evaluation; Radiologic Exam; ABP 980; ALT02; Biceltis; CANMab; CT-P06; CT-P6; Herceptin; Herceptin Biosimilar PF-05280014; Herceptin Trastuzumab Biosimilar PF-05280014; Hercessi; Herclon; Hertraz; Herwenda; Herzuma; HLX 02; HLX-02; HLX02; Kanjinti; Ogivri; Ontruzant; PF 05280014; PF-05280014; PF05280014; QL 1701; QL-1701; QL1701; rhuMAb HER2; RO0452317; SB3; Trastuzumab Biosimilar ABP 980; Trastuzumab Biosimilar ALT02; Trastuzumab Biosimilar CT-P6; trastuzumab biosimilar EG12014; Trastuzumab Biosimilar HLX02; Trastuzumab Biosimilar PF-05280014; Trastuzumab Biosimilar QL1701; Trastuzumab Biosimilar SB3; Trastuzumab Biosimilar SIBP-01; Trastuzumab-anns; Trastuzumab-dkst; Trastuzumab-dttb; Trastuzumab-herw; Trastuzumab-pkrb; Trastuzumab-qyyp; Trastuzumab-strf; Trastuzumab-zerc; Trazimera; Zercepac

Eligibility Criteria

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 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roisin M Connolly

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38433347 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NCI-2023-09506

Identifier Type: REGISTRY

Identifier Source: secondary_id

EAY131-J

Identifier Type: OTHER

Identifier Source: secondary_id

EAY131-J

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2023-09506

Identifier Type: -

Identifier Source: org_study_id