Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT07260175
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cholangiocarcinoma
  • IDH Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivosidenib — DRUG
    Ivosidenib (daily 500 mg) maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma

Study Details

This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma

Key Dates

First listed
Dec 3, 2025
Start date
Nov 18, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivosidenib maintenance
    Ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma

Primary Outcome Measure

recurrence-free survival rate [ Time Frame: 1-year ]

Central Contacts

Related Studies