DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol

Phase 2/3 Recruiting 825 enrolled Cancer Research UK Hoffmann-La Roche · collab Novartis Pharmaceuticals · collab Royal Marsden NHS Foundation Trust · collab University of Birmingham · collab University of Manchester · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

DETERMINE is an open-label phase II/III trial. It will look at targeted treatments in rare cancers or common cancers with rare genetic change (mutation). Patients must have a cancer with an identified mutation. This could be found during routine testing or as part of another research programme. The DETERMINE trial will recruit adults, teenagers and children. If a drug is found to benefit a new patient group, the study team will work with the NHS and the Cancer Drugs Funds to see if these drugs can be available for patients in the future. This clinicaltrials.gov record refers to the Overall Trial Protocol (Master Screening Record), additional records will be added to clinicaltrials.gov for each treatment arm.

Timeline

Start: 2023-03-01
Primary completion: 2029-10
Completion: 2029-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alectinib	Small molecule	600 mg	Oral
Subject	Atezolizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Capmatinib	Small molecule	800 mg	Oral
Subject	Cobimetinib	Small molecule	60 mg	Oral
Subject	Dabrafenib	Small molecule	10 mg	Oral
Subject	Dabrafenib	Small molecule	150 mg	Oral
Subject	Entrectinib	Small molecule	600 mg	Oral
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Trametinib	Small molecule	0.05 mg/m2	Oral
Subject	Trametinib	Small molecule	2 mg	Oral
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Vemurafenib	Small molecule	960 mg	Oral