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|Therapy Name||Linrodostat + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Linrodostat||BMS986205|BMS 986205|ONO-7701|BMS-986205||IDO1 Inhibitor 12||Linrodostat (BMS-986205) inhibits indoleamine 2,3-dioxygenase 1 (IDO1), which results in decreased breakdown of tryptophan into kynurenine in the tumor microenvironment, potentially resulting in enhanced anti-tumor immune response (PMID: 31823654, PMID: 33298590).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 112||Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent NSCLC without EGFR or ALK alterations, in combination with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma, and in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04106414||Phase II||Nivolumab Linrodostat + Nivolumab||Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment||Active, not recruiting||USA||0|
|NCT03519256||Phase II||Linrodostat + Nivolumab Nivolumab BCG solution + Nivolumab BCG solution + Linrodostat + Nivolumab||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 (CheckMate 9UT)||Terminated||USA | ITA | GBR | FRA | ESP | CAN | AUS||8|
|NCT03854032||Phase II||Nivolumab Linrodostat + Nivolumab||Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck||Active, not recruiting||USA||0|
|NCT02658890||Phase Ib/II||Ipilimumab + Linrodostat + Nivolumab Linrodostat + Nivolumab||An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread||Completed||USA | ITA | FRA | ESP | DEU | CAN | AUS||4|
|NCT02750514||Phase II||Dasatinib + Nivolumab Nivolumab + Relatlimab Nivolumab Linrodostat + Nivolumab||An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)||Terminated||USA | ITA | FRA | ESP | CAN | AUT | AUS||1|
|NCT04007588||Phase II||Ipilimumab + Nivolumab Nivolumab Linrodostat + Nivolumab||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||Withdrawn||USA||0|
|NCT04047706||Phase I||Linrodostat + Nivolumab Linrodostat + Nivolumab + Temozolomide||Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma||Active, not recruiting||USA||0|
|NCT03386838||Phase III||Linrodostat + Nivolumab Carboplatin + Cetuximab + Cisplatin + Fluorouracil||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||Withdrawn||USA||0|
|NCT03329846||Phase III||Linrodostat + Nivolumab Nivolumab||An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma||Completed||USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS||8|
|NCT03695250||Phase Ib/II||Linrodostat + Nivolumab||BMS-986205 and Nivolumab as First Line Therapy in Treating Patients With Liver Cancer||Terminated||USA||0|
|NCT03417037||Phase III||Linrodostat + Nivolumab||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||Withdrawn||USA | ITA | FRA | ESP | DEU | CAN | AUT | AUS||9|
|NCT03335540||Phase I||Linrodostat + Nivolumab Nivolumab + Relatlimab Cabiralizumab + Nivolumab Lirilumab + Nivolumab BMS-986156 + Nivolumab Ipilimumab + Nivolumab Nivolumab||An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment||Completed||USA||0|