ProvIDHe

The ProvIDHe study is an early access study of ivosidenib in patients with pretreated locally advanced or metastatic cholangiocarcinoma and is now open in the UK.

This study is evaluating how safe and effective the targeted therapy drug, ivosidenib, is in people previously treated, locally advanced cholangiocarcinoma.

Eligibility criteria includes:

• A diagnosis of nonresectable or metastatic cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies
• A documented IDH1, R132C, R132L, R132G, R132H, or R132S gene-mutated disease
• Have tried at least one prior type of systemic therapy for CCA, and have recovered from any side effects

There are currently 3 sites open and recruiting to this trial in the UK:

• University College London Hospitals NHS Foundation Trust, 
• Imperial College Healthcare NHS Trust 
• The Beatson West of Scotland Cancer Centre. 

It is expected that two to three other Institutions in the UK will open to recruitment for this study soon.  

For further information on this study see:  https://www.clinicaltrials.gov/study/NCT05876754