Trial Title:
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
Condition:
Malignant Solid Neoplasm
Conditions: Official terms:
Trastuzumab
Pertuzumab
Trastuzumab biosimilar HLX02
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (pertuzumab, trastuzumab)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (pertuzumab, trastuzumab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (pertuzumab, trastuzumab)
Other name:
EC
Intervention type:
Biological
Intervention name:
Pertuzumab
Description:
Given IV
Arm group label:
Treatment (pertuzumab, trastuzumab)
Other name:
2C4
Other name:
2C4 Antibody
Other name:
BCD-178
Other name:
EG1206A
Other name:
HLX11
Other name:
HS627
Other name:
MoAb 2C4
Other name:
Monoclonal Antibody 2C4
Other name:
Omnitarg
Other name:
Perjeta
Other name:
Pertuzumab Biosimilar BCD-178
Other name:
Pertuzumab Biosimilar EG1206A
Other name:
Pertuzumab Biosimilar HLX11
Other name:
Pertuzumab Biosimilar HS627
Other name:
Pertuzumab Biosimilar TQB2440
Other name:
Rhumab 2C4
Other name:
rhuMAb2C4
Other name:
RO4368451
Other name:
TQB 2440
Other name:
TQB-2440
Other name:
TQB2440
Intervention type:
Procedure
Intervention name:
Radiologic Examination
Description:
Undergo radiologic evaluation
Arm group label:
Treatment (pertuzumab, trastuzumab)
Other name:
Radiologic Evaluation
Other name:
Radiologic Exam
Intervention type:
Biological
Intervention name:
Trastuzumab
Description:
Given IV
Arm group label:
Treatment (pertuzumab, trastuzumab)
Other name:
ABP 980
Other name:
ALT02
Other name:
Biceltis
Other name:
CANMab
Other name:
CT-P06
Other name:
CT-P6
Other name:
Herceptin
Other name:
Herceptin Biosimilar PF-05280014
Other name:
Herceptin Trastuzumab Biosimilar PF-05280014
Other name:
Hercessi
Other name:
Herclon
Other name:
Hertraz
Other name:
Herwenda
Other name:
Herzuma
Other name:
Kanjinti
Other name:
Ogivri
Other name:
Ontruzant
Other name:
PF-05280014
Other name:
QL 1701
Other name:
QL-1701
Other name:
QL1701
Other name:
rhuMAb HER2
Other name:
RO0452317
Other name:
SB3
Other name:
Trastuzumab Biosimilar ABP 980
Other name:
Trastuzumab Biosimilar ALT02
Other name:
Trastuzumab Biosimilar CT-P6
Other name:
trastuzumab biosimilar EG12014
Other name:
Trastuzumab Biosimilar HLX02
Other name:
Trastuzumab Biosimilar PF-05280014
Other name:
Trastuzumab Biosimilar QL1701
Other name:
Trastuzumab Biosimilar SB3
Other name:
Trastuzumab Biosimilar SIBP-01
Other name:
Trastuzumab-anns
Other name:
Trastuzumab-dkst
Other name:
Trastuzumab-dttb
Other name:
Trastuzumab-herw
Other name:
Trastuzumab-pkrb
Other name:
Trastuzumab-qyyp
Other name:
Trastuzumab-strf
Other name:
Trastuzumab-zerc
Other name:
Trazimera
Other name:
Zercepac
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
March 23, 2017
Completion date:
December 31, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136897
