Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER
About this trial
The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.
Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.
Eligibility criteria
Qualifiers
Signed a written informed consent form prior to any trial specific procedures.
Histologically-proven intrahepatic cholangiocarcinoma, perihilar / distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded).
Locally advanced (non-resectable) or metastatic disease.
Participated in the Screening phase of the SAFIR-ABC10 trial.
Disqualifiers
Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events [NCI-CTCAE v5.0]) before randomisation with the exception of alopecia.
Received first-line maintenance therapy with a matched target therapy proposed in SAFIR ABC10, or any second-line treatment.
Contraindication to ivonescimab.
Proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).
Trial design
Treatments tested in this trial
- Ivonescimab
- FOLFOX regimen
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
UNICANCER
Lead sponsor
Cancer Research UK & UCL Cancer Trials Centre
Collaborator
Belgian Group of Digestive Oncology
Collaborator
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov