This study will evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patients with solid tumors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Oncologie, solide tumoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the efficacy of study treatment in patients with
alteration/biomarker-positive advanced or metastatic solid tumors (for tumor
types that are assessed by RECIST v1.1)
Secondary outcome
The secondary objectives in this study are divided in efficacy and safety.
I Would like to refer to section 'objectives and endpoints', section 2. of the
BO41932 (TAPISTRY) Protocol
Background summary
The current landscape of oncology is rapidly evolving into a more personalized
healthcare approach. Improved understanding of the role of cancer biomarkers,
further development of molecularly targeted therapies, and the standardization
of appropriate targeted treatment into treatment guidelines have shifted
clinical practice to utilize genomic information as an integral component of
clinical decision-making.
Study objective
This study will evaluate the efficacy and safety of multiple therapies that are
selected using somatic alterations and potential predictive biomarkers
identified via NGS assays in patients with solid tumors.
Study design
This umbrella platform study has been designed to evaluate the safety and
efficacy of targeted therapies or immunotherapy as single agents or as part of
rational combinations in patients with unresectable, advanced solid tumors
determined to harbor oncogenic genomic alterations or are TMB-high. Thus,
patients are assigned to treatment cohorts based on the presence of tumor
mutations or other biomarkers that are known or expected to be predictive of
response and/or outcomes.
Cohort A - ROS1 fusion-positive tumors
Cohort B - NTRK1/2/3 fusion-positive tumors
Cohort C - ALK fusion-positive tumors
Cohort D - TMB-high tumors
Cohort F - HER2 mutant-positive tumors
Cohort H - PIK3CA multiple mutant-positive tumors
Cohort I: BRAF class II mutant/fusion-positive tumors
Cohort J: BRAF class III mutant-positive tumors
Cohort K: RET fusion-positive tumors
I would like to refer to section '3' 'Study Design' and for an complete
overview of the study in Figure 1.
Intervention
The Treatment per Cohort is based on Genetic properties of the tumor
Cohort A - Etrectinib - ROS1 fusion-positive tumors
Cohort B - Etrectinib - NTRK1/2/3 fusion-positive tumors
Cohort C - Alecitnib - ALK fusion-positive tumors
Cohort D - Atezolizumab - TMB-high tumors
Cohort F - Trastuzumab Emtansine - HER2 mutant-positive tumors
Cohort G - Idasanutilin - MDM2-amplified, TP53 wild-type tumors
Cohort H - Inavolisib GDC-0077 - PIK3CA multiple mutant-positive tumors
Cohort I: Belvarafenib - BRAF class II mutant/fusion-positive tumors
Cohort J: Belvarafenib - BRAF class III mutant-positive tumors
Cohort K: Pralsetinib -RET fusion-positive tumors
Study burden and risks
For a detailed overview for the different IMPs in this study, I would refer to
the IMP specific Investigator's Brochures.
-Entrectinib
-Alectinib
-Atezolizumab
-Trastuzumab Emtansine
-Inavolinib
-Belvenaferib
-Pralsetinib
We refer to cohort specific ICFs for the schedule of procedures.
Beneluxlaan 2A
Woerden 3446AA
NL
Beneluxlaan 2A
Woerden 3446AA
NL
Listed location countries
Age
Inclusion criteria
• For patients whose biomarker status is unknown and/or for patients with an
ineligible local NGS test result: Signed Biomarker Eligibility Testing Informed
Consent Form and willingness to participate in an assigned cohort based on
their identified oncogenic biomarker(s)
• For patients with a positive biomarker status: Signed cohort-specific
Informed Consent Form.
• Histologically or cytologically confirmed diagnosis of advanced and
unresectable or metastatic solid malignancy
• Measurable disease as defined by Response Evaluation Criteria in Solid
Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO)
criteria, or International Neuroblastoma Response Criteria (INRC)
• Performance status as follows:
o Patients aged =>18 years: Eastern Cooperative Oncology Group (ECOG)
Performance Status 0-2
• For patients aged => 18: adequate hematologic and end-organ function
• Disease progression on prior treatment, or previously untreated disease with
no available acceptable treatment
• Adequate recovery from most recent systemic or local treatment for cancer
• Life expectancy => 8 weeks
• Ability to comply with the study protocol, in the investigator's judgment
• For female patients of childbearing potential: Negative serum pregnancy test
=<14 days prior to initiating study treatment; agreement to remain abstinent or
use single or combined contraception methods that result in a failure rate of <
1% per year for the period defined in the cohort-specific inclusion criteria;
and agreement to refrain from donating eggs during the same period
• For male patients: Willingness to remain abstinent or use acceptable methods
of contraception as defined in the cohort-specific inclusion criteria
Exclusion criteria
• Current participation or enrollment in another therapeutic clinical trial
• Any anticancer treatment within 2 weeks or 5 half-lives (whichever is longer)
prior to start of study treatment
• Whole brain radiotherapy within 14 days prior to start of study treatment
• Stereotactic radiosurgery within 7 days prior to start of study treatment
• Pregnant or breastfeeding, or intending to become pregnant during the study
• History of or concurrent serious medical condition or abnormality in clinical
laboratory tests that, in the investigator's judgment, precludes the patient's
safe participation in and completion of the study or confounds the ability to
interpret data from the study
• Incomplete recovery from any surgery prior to the start of study treatment
that would interfere with the determination of safety or efficacy of study
treatment
• Significant cardiovascular disease, such as New York Heart Association
cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular
accident within 3 months prior to enrollment, unstable arrhythmias, or unstable
angina
History of another active cancer within 5 years prior to screening that may
interfere with the determination of safety or efficacy of study treatment with
respect to the qualifying solid tumor malignancy
Each cohort will also have individual molecule specific inclusion/exclusion
criteria
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 |
---|---|
EudraCT | EUCTR2020-001847-16-NL |
ClinicalTrials.gov | NCT04589845 |
CCMO | NL80032.056.22 |