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Trial designs that test one drug across several cancers sharing a mutation (basket, such as NCI-MATCH), several drugs each matched to a biomarker within one cancer (umbrella, such as Lung-MAP), or keep adding and dropping arms over time (platform, such as I-SPY 2). Basket results underpin tumour-agnostic approvals.
Basket, umbrella and platform trials are designs that respectively test one drug across several cancers, several drugs within one cancer, or keep adding and dropping arms over time. Basket trials such as NCI-MATCH and TAPUR enable tumour-agnostic approvals; umbrella trials such as Lung-MAP allow efficient biomarker-driven testing; and platform trials such as I-SPY 2 in breast cancer randomise adaptively, graduating drugs on predicted pCR. The term is referenced by the STAMPEDE and myeloMATCH trials, by the technologies Digital twins and virtual control arms and N-of-1 and rapid platform trials, and by Nicholas James, Zhi-Ming Shao, Angela DeMichele and Laura J. Esserman. It addresses the bottlenecks on rare cancers without markets, slow trial enrolment and trial design and cost.
Shares A RECOVERY-style permanent platform trial of cheap drugs added to cancer care, One ethics approval and one consent form for a platform trial across countries, A standing platform trial that assigns treatment by how the tumour escaped, Let the trial learn: response-adaptive allocation across many combination arms.
Shares A standing platform trial that assigns treatment by how the tumour escaped, ComboMATCH (EAY191), Zhi-Ming Shao, A DRUP-style protocol for off-label generic targeted drugs in rare tumours.
Shares Agree in advance how to borrow evidence between similar rare cancers, One global rare cancer network with n-of-1 and Bayesian trial frameworks, Randomise inside the registry that already follows every patient, One standing umbrella trial for all rare cancers in a country.
Shares Response-adaptive randomisation, Basket trial, Digital twins and virtual control arms, Seamless, adaptive and Bayesian trial designs.
Shares A RECOVERY-style permanent platform trial of cheap drugs added to cancer care, DETERMINE arm 04: trastuzumab with pertuzumab in HER2-amplified or mutated rare cancers, A perpetual platform trial in every major cancer, funded as infrastructure, A national platform trial that every ctDNA-positive patient can join.
Shares Just-in-time site activation: open a site in two weeks when a patient appears, N-of-1 and rapid platform trials, A national platform trial that every ctDNA-positive patient can join, One standing umbrella trial for all rare cancers in a country.
Shares ComboMATCH (EAY191), One master trial for cancer prevention drugs across many precancers, Lung-MAP S1400I: nivolumab with or without ipilimumab, A perpetual platform trial in every major cancer, funded as infrastructure.
Shares I-PREDICT, DART (SWOG S1609): nivolumab plus ipilimumab in rare tumours, WINTHER, Master protocol (platform, basket and umbrella trials).