TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIA
- Conditions
- Oncologielocally advanced or metastatic solid tumors
- Registration Number
- NL-OMON55185
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
* 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)
* 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:
* Patients aged ><= 18 years: Eastern Cooperative Oncology Group (ECOG)
Performance Status 0-2
* Patients aged 16 to < 18 years: Karnofsky score ><= 50%
* Patients aged < 16 years: Lansky score ><= 50%
* For patients aged ><= 18 and <18 years: 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
* Current participation or enrollment in another therapeutic clinical trial
* Any anticancer treatment within 2 weeks or 5 half-lives 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the efficacy of study treatment in patients with<br /><br>alteration/biomarker-positive advanced or metastatic solid tumors (for tumor<br /><br>types that are assessed by RECIST v1.1)</p><br>
- Secondary Outcome Measures
Name Time Method <p>the secondary objectives in this study are divided in efficacy and safety.<br /><br><br /><br>I Would like to refer to section 'objectives and endpoints', section 2. of the<br /><br>BO41932 (TAPESTRY) Protocol</p><br>