adIVO

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

18 Nov 2025 → ongoing

Decision date (initial)

2025-09-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Servier Affaires Médicales (France) · Servier Deutschland GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the efficacy of ivosidenib maintenance directly after adjuvant SOC chemotherapy in curative mIDH1 iCCA.

Secondary objectives 1

1. To evaluate further efficacy as well as to assess safety and impact on the quality of life of ivosidenib maintenance directly after adjuvant SOC chemotherapy in curative mIDH1 iCCA.

Conditions and MedDRA coding

ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Patient* provides signed informed consent.
2. Patient is ≥ 18 years at the time of given informed consent.
3. Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)
4. 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 pyrosequencing)
5. Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.
6. 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).
7. Patient has ECOG Performance status ≤ 1
8. Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.
9. 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.
10. 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.
11. 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 (see section 5.2.6 for more information).
12. 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.

Exclusion criteria 15

1. Patient has a metastatic or R+ resected biliary tract cancer.
2. Patient received previous therapy with an IDH1 inhibitor.
3. Patient has known presence of tumors other than intrahepatic cholangiocarcinoma or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.
4. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol.
5. Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy only for symptom control).
6. Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.
7. Patient has known allergic / hypersensitive reactions to at least one of the treatment components.
8. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial.
9. Patient has a known presence of an active, uncontrollable infection.
10. Patient has QTc > 480ms or other factors that, in the discretion of the investigator increase significantly the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome). NOTE: Medications that prolong the QT interval should be avoided, unless they can be transferred to other medication within ≥ 5 half-lives to dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTc should be closely monitored).
11. Patient has active disseminated intravascular coagulation.
12. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
13. Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.
14. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. NOTE: strong CYP3A4 inducers or sensitive CYP3A4 substrates with narrow therapeutic window should be avoided, unless they can be transferred to alternative medication within at least 5-half lives prior to dosing.
15. Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1-year recurrence-free survival rate (RFS@1year), defined as proportion of patients alive with no disease recurrence 1 year after start of maintenance ivosidenib

Secondary endpoints 6

1. RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause
2. Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence
3. Time to treatment failure (TTF), defined as time from start of ivosidenib maintenance to the date of premature treatment discontinuation from any cause, including disease recurrence, treatment toxicity or death
4. Overall survival (OS), defined as time from enrollment to the date of death from any cause
5. Safety
6. Quality of life using EORTC QLQ-C30 and EORTC QLQ-BIL21 questionnaires

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Sponsor organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Address

Steinbacher Hohl 2-26, Praunheim Praunheim

City

Frankfurt Am Main

Postcode

60488

Country

Germany

Scientific contact point

Organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Contact name

Clinical trial project management

Public contact point

Organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Contact name

Clinical trial project management

Third parties 1

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications