adIVO - A Phase II Trial of Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Patient\* provides signed informed consent.

• Patient is ≥ 18 years at the time of given informed consent.

• Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)

• Patient has proven IDH1 mutation (IDH1-variant status evaluated locally by certified test on formalin-fixed paraffin-embedded tumor tissue specimen. If local testing for screening is not possible per local standard, tumor tissue samples will be subject to pre-screening via central IDH1 dPCR)

• Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.

• Radiologic imaging available that shows that patient is tumor free at the timepoint of enrollment (not older than 6 weeks from the day of inclusion).

• Patient has ECOG Performance status ≤ 1

• Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.

• Patient has adequate coagulability to allow targeted therapy with ivosidenib at investigator´s discretion and IB. Patients receiving warfarin / Phenprocoumon must be switched to low molecular weight heparin and before starting trial-specific.

⁃ Patient must be willingly to provide liquid biopsy samples, archival tumor tissue samples (if available), and in the event of disease recurrence, re-biopsy samples (if re-biopsy is considered safe for the patient) for the translational research program.

⁃ Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 6 months after the last dose of trial treatment. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.

⁃ Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up.

Locations
Other Locations
Germany
Institute for Clinical Cancer Research Krankenhaus Nordwest
RECRUITING
Frankfurt
Krankenhaus Nordwest
RECRUITING
Frankfurt
Uniklinikum Jena
RECRUITING
Jena
Klinikum rechts der Isar TU München
RECRUITING
München
Contact Information
Primary
Thorsten Götze, Prof. Dr.
Goetze.Thorsten@KHNW.DE
+49 69 76 01
Backup
Johanna Riedel, Dr.
riedel.johanna@ikf-khnw.de
+49 69 5899 787
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2031-12
Participants
Target number of participants: 40
Treatments
Experimental: Ivosidenib maintenance
Ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
Related Therapeutic Areas
Sponsors
Leads: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Servier Deutschland GmbH, Servier Affaires Médicales

This content was sourced from clinicaltrials.gov