Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136897
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-11-15
Brief Title:
Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors MATCH - Subprotocol J
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol J Trastuzumab and Pertuzumab HP in Patients With Non-Breast Non-GastricGEJ and Non-Colorectal Cancers With HER2 Amplification
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II MATCH treatment trial tests how well trastuzumab and pertuzumab work in treating patients with HER2-amplified non-breast non-gastricgastroesophageal 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 bodys 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 arent breast gastric or colorectal
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple 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 cancerslymphomasmultiple 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
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple 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 cancerslymphomasmultiple 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-09506 | REGISTRY | None | None |
| EAY131-J | OTHER | None | None |
| EAY131-J | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |