DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations

NCT05722886 Phase 2/Phase 3 RECRUITING

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.

Details

Lead sponsor	Cancer Research UK
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	825
Start date	2023-03-01
Completion	2029-10

Conditions

• Haematological Malignancy
• Solid Tumour

Interventions

• Alectinib
• Atezolizumab
• Entrectinib
• Trastuzumab in combination with pertuzumab
• Vemurafenib in combination with cobimetinib
• Capmatinib

Primary outcomes

• Number of patients who consent to each arm. — Up to 5 years.
  This is a master screening entry with sub-study entries to capture the results of each arm. As such a primary outcome measure for this entry is not relevant, however this entry will be used to report the number of patients with a cancer containing the appropriate genetic alteration that have been successfully allocated and consented to each arm.

Countries

United Kingdom