Pre-surgery platform trials that test combinations on pathological response in months
Give combinations before surgery and look at how much tumour is left when it is removed. That answer comes in months, so many pairs can be tested quickly.
I-SPY 2 established graduation of arms by pathological complete response in breast cancer. The same model applies to lung, bladder, melanoma, head and neck and oesophago-gastric cancer where neoadjuvant therapy is now standard. Each cancer needs a standing neoadjuvant platform with a shared control arm and pre-agreed rules for graduating an arm to a confirmatory trial.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
Pages like this
not linked directly; found by shared links- IdeaUse pre-surgery immunotherapy windows as the field's biomarker engine
Shares Major pathological response (MPR), NADINA, Pathologic complete response (pCR), Trial design, endpoints and cost.
- TrialASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)
Shares Residual cancer burden (RCB), KEYNOTE-522, Pathologic complete response (pCR).
- PersonLaura J. Esserman
Shares Residual cancer burden (RCB), Pathologic complete response (pCR), Basket, umbrella, and platform trials.
- IdeaKill combination arms early using circulating tumour DNA, before waiting for scans
Shares Let the trial learn: response-adaptive allocation across many combination arms, Too many combinations to test, Trial design, endpoints and cost.
- IdeaADC for residual disease after KEYNOTE-522
Shares Residual cancer burden (RCB), KEYNOTE-522, Pathologic complete response (pCR).
- IdeaA standing platform trial for every major cancer, funded as infrastructure
Shares Basket, umbrella, and platform trials, Too many combinations to test, Trial design, endpoints and cost.
- IdeaCompeting sponsors share one control arm in the same indication
Shares Basket, umbrella, and platform trials, Trial design, endpoints and cost, Non-small-cell lung cancer.
- IdeaTreat the draining lymph node before removing it
Shares Major pathological response (MPR), Head and neck squamous cell carcinoma, Melanoma.