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|Therapy Name||BMS-986205 + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|BMS-986205||BMS986205|BMS 986205|ONO-7701|Linrodostat||IDO1 Inhibitor 10 Immune Checkpoint Inhibitor 98||BMS-986205 (Linrodostat) inhibits indoleamine 2,3-dioxygenase 1 (IDO1) to prevent tryptophan breakdown in the tumor microenvironment, thereby activating a cytotoxic immune response against IDO1 expressing tumor cells (PMID: 29167110, PMID: 31823654).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 67||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, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and esophageal squamous cell carcinoma, 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 non-small cell lung cancer without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations, and in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||cervical cancer||not applicable||BMS-986205 + Nivolumab||Phase Ib/II||Actionable||In a Phase I/II trial, BMS-986205 in combination with Opdivo (nivolumab) resulted in an objective response rate of 14% (3/22) and a durable response rate of 64% (14/22) in patients with cervical cancer (PMID: 29167110).||29167110|
|Unknown unknown||urinary bladder cancer||not applicable||BMS-986205 + Nivolumab||Phase I||Actionable||In a Phase I/II trial, BMS-986205 in combination with Opdivo (nivolumab) resulted in an objective response rate of 32% (8/25) and a durable response rate of 44% (11/25) in patients with bladder cancer (PMID: 29167110).||29167110|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03417037||Phase III||BMS-986205 + 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 | CAN||15|
|NCT03519256||Phase II||BMS-986205 + Nivolumab Nivolumab BCG solution + Nivolumab BCG solution + BMS-986205 + 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)||Recruiting||USA | CAN||14|
|NCT03695250||Phase Ib/II||BMS-986205 + Nivolumab||BMS-986205 and Nivolumab as First Line Therapy in Treating Patients With Liver Cancer||Recruiting||USA||0|
|NCT02750514||Phase II||Dasatinib + Nivolumab Nivolumab + Relatlimab Nivolumab BMS-986205 + Nivolumab||An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)||Terminated||USA | CAN||6|
|NCT04047706||Phase I||BMS-986205 + Nivolumab BMS-986205 + Nivolumab + Temozolomide||Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma||Recruiting||USA||0|
|NCT03854032||Phase II||Nivolumab BMS-986205 + Nivolumab||Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck||Recruiting||USA||0|
|NCT04007588||Phase II||Ipilimumab + Nivolumab Nivolumab BMS-986205 + 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|
|NCT02658890||Phase Ib/II||BMS-986205 + Ipilimumab + Nivolumab BMS-986205 + 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||Recruiting||USA | CAN||9|
|NCT03335540||Phase I||BMS-986205 + 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||Recruiting||USA||0|
|NCT03329846||Phase III||BMS-986205 + 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 | CAN||14|
|NCT03386838||Phase III||BMS-986205 + 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|
|NCT04106414||Phase II||Nivolumab BMS-986205 + Nivolumab||Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment||Recruiting||USA||0|