Health TrialsbyHealthPanel

Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Pharmaceutical Co., Ltd.

About this trial

To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;

Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);

Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.

Has radiographically measurable disease per RECIST v1.1.

Disqualifiers

History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;

History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;

Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib

Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Futibatinib

    Drug

    Futibatinib 20 mg will be administered orally once daily.

  • Zimberelimab

    Drug

    Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.

  • Durvalumab

    Drug

    Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.

  • Pembrolizumab

    Drug

    Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.

  • Gemcitabine

    Drug

    Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

  • Cisplatin

    Drug

    Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

Treatment groups

784 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 4 interventions
Group B: Control ArmActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

* To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC whose primary tumor site is intrahepatic or extrahepatic cholangiocarcinoma * To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC

Time frame
Up to approximately 45 months

Secondary outcomes

1

Progression-Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 using Blinded Independent Central Review (BICR) and Investigator assessment

Time frame
Up to approximately 45 months
2

6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments

Time frame
Up to approximately 45 months
3

Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments

Time frame
Up to approximately 45 months
4

Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments

Time frame
Up to approximately 45 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taiho Pharmaceutical Co., Ltd.

Lead sponsor

Taiho Oncology, Inc.

Collaborator

Source ClinicalTrials.gov
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