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

Plain English Summary

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) is a Phase 2 clinical trial sponsored by National Cancer Institute (NCI) studying Malignant Solid Neoplasm. This trial tests if two drugs, trastuzumab and pertuzumab, can treat certain cancers that have too much of a protein called HER2. It is for patients with specific types of solid tumors (not breast, stomach, or colon cancer) that have a genetic change called HER2 amplification. Participation involves receiving the study drugs and undergoing regular tests, including biopsies and imaging scans. Alternative treatments would depend on the specific cancer type and may include chemotherapy, surgery, or other targeted therapies. The trial aims to enroll 35 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients must have a confirmed HER2 amplification in their tumor. Must not have breast, gastric/GEJ, or colorectal cancer. Must have normal heart function as assessed by ECG and echocardiogram/MUGA scan. Must not have received prior treatments targeting HER2. This trial is studying Malignant Solid Neoplasm, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see how often the combination of trastuzumab and pertuzumab shrinks tumors, indicating the treatment's effectiveness. The specific primary outcome measures are: Objective Response Rate (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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a gap in treating rare cancers with HER2 amplification, offering a targeted therapy option where few exist. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Malignant Solid Neoplasm, where improved treatment options are needed.

Investor Insight

This trial signals interest in expanding HER2-targeted therapies beyond common cancers, potentially opening new markets if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your cancer has HER2 amplification and if this trial is a suitable option for you. Be prepared for regular clinic visits for drug infusions and diagnostic tests like scans and biopsies. Discuss any heart conditions or concerns with your doctor, as heart function is closely monitored. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 35 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo biopsy
• PROCEDURE: Biospecimen Collection — Undergo collection of blood samples
• PROCEDURE: Echocardiography Test — Undergo ECHO
• BIOLOGICAL: Pertuzumab — Given IV
• PROCEDURE: Radiologic Examination — Undergo radiologic evaluation

Primary Outcomes

• Objective Response Rate (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

• 6-month Progression-Free Survival (PFS) Rate (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 (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)

Full 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

Trial Locations

• ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Frequently Asked Questions

Related Conditions

• Malignant Solid Neoplasm
• HER2-Amplified Cancers
• Targeted Cancer Therapy
• Oncology
• Gastrointestinal Cancers (excluding specific types)
• Esophageal Adenocarcinoma
• Colorectal Adenocarcinoma
• Breast Cancer (as a comparison for HER2 targeting)
• Rare Cancers
• Genomic Medicine

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