The objective of this study is to evaluate the performance of HercepTest* mAb pharmDx (Dako Omnis) (GE001) and HER2 IQFISH pharmDx (K5731) in identifying subjects with HER2 positivity (IHC 3+ or IHC 2+/ISH +) for the clinical trial DESTINY-Gastric05…
ID
Source
Brief title
Synonym
Health condition
Oncology - Gastric or Gastroesophageal Junction Cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the trial is progression free survival as assessed by
Blinded Independent Central Review, defined as the time interval from the date
of randomization to the date of radiographic disease progression or death due
to any cause. The objective of the primary efficacy analysis is to compare the
progression free survival between the two arms within each cohort.
Secondary outcome
The key secondary endpoint is overall survival, defined as the time interval
from the date of randomization to the date of death due to any cause. The
objective of the key secondary efficacy analysis is to compare the overall
survival between the two arms within each cohort.
Calculate incidences of, for example, serious adverse events,
treatment-emergent adverse events to assess safety and tolerability between
arms within each cohort.
Background summary
HercepTest* mAb pharmDx (Dako Omnis) and HER2 IQFISH pharmDx will be used for
HER2-positive patient selection in the DESTINY-Gastric05 clinical trial.
HercepTest* mAb pharmDx (Dako Omnis) is a semi-quantitative immunohistochemical
assay based on a primary monoclonal rabbit antibody (clone DAK-HcT-2 (DG44))
and an assay-specific visualization reagent. The assay determines HER2 protein
overexpression in formalin-fixed, paraffin-embedded (FFPE) human cancer tissues
processed for histological evaluation. HercepTest* mAb pharmDx (Dako Omnis) is
for automated staining using Dako Omnis.
HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay
designed to quantitatively determine HER2 gene amplification in FFPE tissue
from patients with metastatic gastric or GEJ adenocarcinoma.
The current best practice of HER2 testing in gastric cancer is based on
American Society of Clinical Oncology - College of American Pathologist
(ASCO-CAP) publication 24. HER2 positivity of gastric or GEJ cancer is defined
as centrally determined HER2 positive (IHC 3+ or IHC 2+/ISH +) as classified by
ASCO-CAP.
Study objective
The objective of this study is to evaluate the performance of HercepTest* mAb
pharmDx (Dako Omnis) (GE001) and HER2 IQFISH pharmDx (K5731) in identifying
subjects with HER2 positivity (IHC 3+ or IHC 2+/ISH +) for the clinical trial
DESTINY-Gastric05.
Study design
DESTINY-Gastric05 is a multicenter, randomized, open-label, Phase 3 clinical
trial, is designed to assess the efficacy and safety of the triplet combination
of trastuzumab deruxtecan (ENHERTU®, T-DXd, DS-8201a) plus a fluoropyrimidine
plus pembrolizumab versus Standard of Care (SoC) chemotherapy plus trastuzumab
plus pembrolizumab as first-line therapy in participants with unresectable,
locally advanced or metastatic HER2-positive tumor (determined by HercepTest*
mAb pharmDx (Dako Omnis) and HER2 IQFISH pharmDx) PD-L1 CPS >=1 (determined by
PD-L1 IHC 22C3 pharmDx, demonstrated in a separate CPSP D0118539) gastric or
GEJ cancer in the Main Cohort. HER2 positive, PD-L1 CPS <1 population will be
enrolled to Exploratory Cohort.
Intervention
Biopsies will be obtained in the context of the pharmaceutical study (only in
the event that a suitable archived sample is not available)
Study burden and risks
Collection of tissue biopsy is considered part of standard clinical to
determine the most appropriate therapeutic option for Gastric or
Gastroesophageal Junction cancer patients.
The possible complications include: bleeding, bruising, swelling, infection, or
scarring at the site of the biopsy. A brief, sharp pain from the needle used
for anesthesia. The biopsy needle will produce a dull pain.
Very rarely, complications from biopsies can be life-threatening.
Potentially serious complications from bleeding or organ damage may occur that
might require additional surgical intervention. There is a risk of regional
spread of cancer cells when the needle is removed from the tumor.
There is a chance of false results. A false positive result may lead to study
drugs that are not medically necessary and also may result in side effects. A
false negative result may occur, leading to being excluded from this study, and
not receiving the study drugs. There is a risk of
delays in obtaining and/or providing results, and a risk that additional
samples or re-biopsy may
be required.
Mt. Airy Road 211
Basking Ridge NJ 07920
US
Mt. Airy Road 211
Basking Ridge NJ 07920
US
Listed location countries
Age
Inclusion criteria
Sign and date the Tissue Prescreening ICF, prior to HER2 and PD-L1 CPS central
testing.
• All participants must provide a tumor sample for tissue-based IHC staining to
centrally determine HER2 expression and PD-L1 CPS status.
• Enrollment in this clinical study is based on centrally determined HER2
positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ cancer as classified by
ASCO-CAP for gastric cancer on a tumor biopsy as detected by prospective
central test on new (core, incisional, excisional biopsy) or existing tumor
tissue taken at the time of diagnosis of locally advanced or metastatic disease.
• Centrally determined tumor PD-L1 CPS status using the PD-L1 IHC 22C3 PharmDx:
- For the Main Cohort: PD-L1 CPS >=1
- For the Exploratory Cohort: PD-L1 CPS <1
Exclusion criteria
• Prior exposure to other HER2-targeting therapies.
• Cytology specimens or decalcified tissues.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88600.000.24 |