Trial Outcomes & Findings for Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma (NCT NCT05921760)

NCT ID: NCT05921760

Last Updated: 2026-04-20

Results Overview

Occurring during the safety lead-in phase

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Through the end of Cycle 2, day 42 (Cycle 1 and 2 are each 21 days)

Results posted on

2026-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Safety Lead-In Phase - Ivosidenib 500mg Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Overall Study STARTED	4	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Lead-In Phase - Ivosidenib 500mg Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Overall Study Withdrawal by Subject	0	1
Overall Study Death	3	2
Overall Study Sponsor Terminated the Study	1	0

Baseline Characteristics

Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Total n=7 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 20.61 • n=129 Participants	49.3 years STANDARD_DEVIATION 15.37 • n=22 Participants	55.9 years STANDARD_DEVIATION 18.12 • n=151 Participants
Age, Customized < 65 years	2 Participants n=129 Participants	2 Participants n=22 Participants	4 Participants n=151 Participants
Age, Customized ≥ 65 years	2 Participants n=129 Participants	1 Participants n=22 Participants	3 Participants n=151 Participants
Sex: Female, Male Female	4 Participants n=129 Participants	3 Participants n=22 Participants	7 Participants n=151 Participants
Sex: Female, Male Male	0 Participants n=129 Participants	0 Participants n=22 Participants	0 Participants n=151 Participants
Race/Ethnicity, Customized Asian	1 Participants n=129 Participants	0 Participants n=22 Participants	1 Participants n=151 Participants
Race/Ethnicity, Customized White	3 Participants n=129 Participants	3 Participants n=22 Participants	6 Participants n=151 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=129 Participants	3 Participants n=22 Participants	6 Participants n=151 Participants
Race/Ethnicity, Customized Missing	1 Participants n=129 Participants	0 Participants n=22 Participants	1 Participants n=151 Participants
Region of Enrollment United States	4 participants n=129 Participants	1 participants n=22 Participants	5 participants n=151 Participants
Region of Enrollment United Kingdom	0 participants n=129 Participants	2 participants n=22 Participants	2 participants n=151 Participants
BMI	26.80 kg/m^2 STANDARD_DEVIATION 6.347 • n=129 Participants	23.33 kg/m^2 STANDARD_DEVIATION 2.114 • n=22 Participants	25.31 kg/m^2 STANDARD_DEVIATION 5.007 • n=151 Participants

PRIMARY outcome

Timeframe: Through the end of Cycle 2, day 42 (Cycle 1 and 2 are each 21 days)

Occurring during the safety lead-in phase

Outcome measures

Outcome measures
Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Safety Lead-In Phase: Number of Dose Limiting Toxicities (DLTs) Associated With Study Drug Regimen, During the First 2 Cycles of Treatment	0 DLT events	1 DLT events

PRIMARY outcome

Timeframe: Through study termination (approximately 1 year)

Occurring during the safety lead-in phase

Outcome measures

Outcome measures
Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Safety Lead-In Phase: Number of Adverse Events (AEs)	71 events	27 events

PRIMARY outcome

Timeframe: Through study termination (approximately 1 year)

Occurring during the safety lead-in phase

Outcome measures

Outcome measures
Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Safety Lead-In Phase: Number of Participants With Adverse Events of Special Interests (AESIs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Through study termination (approximately 1 year)

Occurring during the safety lead-in phase

Outcome measures

Outcome measures
Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 Participants Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Safety Lead-In Phase: Number of Serious Adverse Events (SAEs)	3 events	2 events

SECONDARY outcome

Timeframe: Up to 3 years

Population: PK and PD samples were not analyzed due to the premature stop of the study and several dosing interruptions. The samples will not be analyzed in the future. Therefore, there is no parameter data available to be entered for this outcome measure.

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Occurring during the safety lead-in phase

Outcome measures

Outcome data not reported

Adverse Events

Safety Lead-In Phase - Ivosidenib 500mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Safety Lead-In Phase - Ivosidenib 250mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 participants at risk First phase of the study. Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 participants at risk First phase of the study. Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	66.7% 2/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Hepatobiliary disorders Immune-mediated hepatitis	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
General disorders Pyrexia	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.

Other adverse events

Additional Information

Institut de Recherches Internationales Servier (I.R.I.S.)

Clinical Studies Department

Phone: +33 1 55 72 60 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Safety Lead-In Phase - Ivosidenib 500mg n=4 participants at risk First phase of the study. Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion	Safety Lead-In Phase - Ivosidenib 250mg n=3 participants at risk First phase of the study. Ivosidenib: ivosidenib taken once daily Nivolumab: Nivolumab taken by intravenous infusion Ipilimumab: Ipilimumab taken by intravenous infusion
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Investigations Aspartate aminotransferase increased	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Investigations Blood bilirubin increased	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Investigations Cardiac murmur	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Nervous system disorders Dizziness	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Nervous system disorders Taste disorder	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Nervous system disorders Burning sensation	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Nervous system disorders Tremor	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Cardiac disorders Palpitations	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Cardiac disorders Tachycardia	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Eye disorders Dry eye	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Reproductive system and breast disorders Pruritus genital	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Diarrhoea	75.0% 3/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Nausea	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Constipation	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Dry mouth	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Malignant ascites	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	66.7% 2/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Eructation	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Hyperaesthesia teeth	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	75.0% 3/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Skin and subcutaneous tissue disorders Pruritus	75.0% 3/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
General disorders Fatigue	100.0% 4/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
General disorders Pyrexia	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
General disorders Oedema peripheral	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
General disorders Chills	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 2/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations Candida infection	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations COVID-19	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations Device related infection	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations Kidney infection	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations Oral candidiasis	0.00% 0/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Infections and infestations Urinary tract infection	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	33.3% 1/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.	0.00% 0/3 • Through study termination (approximately 1 year) Adverse events were collected during participant visits.