linrodostat: Clinical Trials

15 completed, 4 terminated, 3 withdrawn, 2 active not recruiting. 14 Phase 1, 11 Phase 2, 3 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	14	Completed 12, Active not recruiting 1, Terminated 1
Phase 2	11	Completed 5, Terminated 4, Active not recruiting 1, Withdrawn 1
Phase 3	3	Withdrawn 2, Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment Nivolumab, BMS- 986205 - Endometrial Adenocarcinoma, Endometrial Carcinosarcoma	Phase 2	Active not recruiting	Memorial Sloan Kettering Cancer Center	24	2019-09-24	2026-10-16
A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma Nivolumab, BMS-986205, Ipilimumab - Melanoma Stage III, Melanoma Stage IV	Phase 2	Withdrawn	Dana-Farber Cancer Institute		2019-09-06	2020-02-05
Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma IDO1 Inhibitor BMS-986205 25mg, Nivolumab, Radiation Therapy - Glioblastoma	Phase 1	Active not recruiting	Northwestern University	18	2019-08-13	2025-06-29
A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants BMS-986205, omeprazole - Healthy	Phase 1	Completed	Bristol-Myers Squibb	16	2019-05-08	2019-09-23
Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck Nivolumab, IDO1 Inhibitor BMS-986205, Therapeutic Conventional Surgery - Lip, Oral Cavity Squamous Cell Carcinoma	Phase 2	Terminated	Thomas Jefferson University	65	2019-04-09	2026-10-19
A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors BMS-986205, Nivolumab - Advanced Cancer	Phase 1 / Phase 2	Completed	Bristol-Myers Squibb	12	2018-12-31	2022-02-28
BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer IDO1 Inhibitor BMS-986205, Nivolumab - Metastatic Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8	Phase 1 / Phase 2	Terminated	Edward Kim	8	2018-10-16	2026-07-29
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder Nivolumab, BCG, BMS-986205 - Urinary Bladder Neoplasms	Phase 2	Terminated	Bristol-Myers Squibb	142	2018-08-02	2023-06-01
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread Relatlimab, Nivolumab, BMS-986205 - Advanced Cancer	Phase 1 / Phase 2	Completed	Bristol-Myers Squibb	229	2018-05-30	2026-04-06
An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer BMS-986205, Nivolumab, Chemotherapy - Lung Cancer, Non-Small Cell Lung Cancer	Phase 3	Withdrawn	Bristol-Myers Squibb		2018-05-24	2018-04-30
An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment Nivolumab, Relatlimab, Cabiralizumab - Advanced Cancer	Phase 1	Completed	Bristol-Myers Squibb	20	2018-05-07	2022-09-26
An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck Nivolumab, BMS-986205, Cetuximab - Head and Neck Cancer	Phase 3	Withdrawn	Bristol-Myers Squibb		2018-03-28	2019-04-18
A Study to Evaluate the Bioavailability of BMS-986205 BMS-986205 - Healthy Participants	Phase 1	Completed	Bristol-Myers Squibb	7	2018-01-04	2018-06-28
A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet BMS-986205 reference tablet, BMS-986205 tablet with free base - Healthy Volunteers	Phase 1	Completed	Bristol-Myers Squibb	16	2017-12-21	2018-02-28
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma BMS-986205, Nivolumab, Placebo - Melanoma, Skin Cancer	Phase 3	Completed	Bristol-Myers Squibb	20	2017-11-30	2021-07-09
A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects BMS-986205, Itraconazole, Rifampin - Malignancies Multiple	Phase 1	Completed	Bristol-Myers Squibb	53	2017-11-22	2018-02-28
A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet BMS-986205 - Healthy Volunteers	Phase 1	Completed	Bristol-Myers Squibb	40	2017-11-09	2018-02-23
An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy Participants BMS-986205 - Healthy Volunteers	Phase 1	Completed	Bristol-Myers Squibb	32	2017-10-09	2018-01-19
Pharmacokinetics and Metabolism Study in Healthy Male Participants BMS-986205 - Cancer	Phase 1	Completed	Bristol-Myers Squibb	9	2017-07-19	2017-11-06
A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors BMS-986205, Nivolumab - Advanced Cancer	Phase 1	Completed	Bristol-Myers Squibb	11	2017-06-23	2019-04-01

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Conditions studied

Melanoma (3)  ·  Carcinoma, Non-Small-Cell Lung (2)  ·  Neoplasms (2)  ·  Carcinoma, Hepatocellular (1)  ·  Carcinoma, Squamous Cell (1)  ·  Glioblastoma (1)  ·  Head and Neck Neoplasms (1)  ·  Laryngeal Diseases (1)  ·  Lung Neoplasms (1)  ·  Lymphoid Interstitial Pneumonia (1)  ·  Non-Muscle Invasive Bladder Neoplasms (1)  ·  Skin Neoplasms (1)  ·  Squamous Cell Carcinoma of Head and Neck (1)  ·  Urinary Bladder Neoplasms (1)

Sponsors

Bristol-Myers Squibb (19)  ·  Dana-Farber Cancer Institute (1)  ·  Edward Kim (1)  ·  Memorial Sloan Kettering Cancer Center (1)  ·  Northwestern University (1)  ·  Thomas Jefferson University (1)

Countries

United States (21)  ·  Australia (8)  ·  Italy (8)  ·  Canada (7)  ·  France (6)  ·  Spain (6)  ·  Switzerland (5)  ·  Germany (4)  ·  United Kingdom (4)  ·  Austria (3)  ·  Japan (3)  ·  Netherlands (3)  ·  Brazil (2)  ·  China (2)  ·  Czechia (2)

Top investigators

Adam Luginbuhl, MD (1)  ·  Antonia Davidson, MD (1)  ·  Chrisann Kyi, MD (1)  ·  Edward Kim, MD, PhD (1)  ·  Elizabeth I Buchbinder, MD (1)  ·  Rimas V Lukas, MD (1)

Results publications

PMID 36328377, PMID 40389374, PMID 41041559, PMID 42189896

NIH funding

2017 (5), 2016 (2), 2015 (1), 2018 (1), P30CA060553 (1), P30CA093373 (1), P50CA221747 (1)