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| Diagnosis | Solid tumors with eligible genetic change | Study Status | Open |
| Phase | II |
| Age | Child (Under 18 Years) | Randomisation | NO |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Entrectinib - oral
Atezolizumab - IV
Ipatasertib - oral
Alectinib - oral
Trastuzumab - IV
GDC-0077 (Inavolisib) - oral
Belvarafenib - oral
Pralsetinib - oral |
| Last Posted Update | 2024-04-29 |
| ClinicalTrials.gov # | NCT04589845 |
International Sponsor
Hoffmann-La RochePrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
(from https://forpatients.roche.com/en/trials/cancer/solid-tumors/tumor-agnostic-precision-immuno-oncology-and-somatic-ta-50851.html)
This clinical trial is recruiting people who have advanced solid tumors that cannot be surgically removed. You (or your child) must have had genetic testing on the solid tumors that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.
The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumors that cannot be surgically removed and show specific biomarkers.
To be able to take part in this clinical trial, you (or your child) must have been diagnosed with solid tumors that cannot be surgically removed and show one of the specific biomarkers that are being tested in this study:
- ROS1 fusion-positive tumors
- NTRK1/2/3 fusion-positive tumors
- TMB-high tumors
- ALK fusion-positive
- AKT1/2/3 mutant-positive tumors
- HER2 mutant-positive tumors
- PIK3CA multiple mutant-positive tumors
- BRAF class II mutant or fusion-positive tumors
- BRAF class III mutant-positive tumors
- RET fusion-positive tumors
Your doctor will be able to give you more information on the type of biomarker your solid tumors show. You must be otherwise in good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.
Inclusion Criteria
- Less than 18 years of age for cohort E and K
- Age between 12 and 17 years for cohorts E, F and H
- Diagnosis of advanced cancer that has spread to a different part of the body (metastasized) and can’t be removed by an operation (unresectable)
- Participants must be up and about at least 50% of their waking hours
- The cancer must have a specific genetic change in one of the following genes: ROS1, NTRK1/2/3, AKT, PIK3CA, HER2, BRAF, RET, or be TMB-high
Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
