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|Therapy Name||Cabiralizumab + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cabiralizumab||FPA008|FPA-008|FPA 008|BMS-986227||CSF1R Antibody 4||Cabiralizumab (FPA008) is a monoclonal antibody that targets the ligand-binding domain of CSF1R (PMID: 26051995).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 151 PD-L1/PD-1 antibody 98||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|
|NCT04848116||Phase II||Cabiralizumab + Nivolumab BMS-986253 + Nivolumab Nivolumab||Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca (Spark2)||Recruiting||USA||0|
|NCT03599362||Phase II||Cabiralizumab + Nivolumab||Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer||Terminated||USA||0|
|NCT04050462||Phase II||BMS-986253 + Nivolumab Nivolumab Cabiralizumab + Nivolumab||A Phase II, Randomized, Controlled Trial of Nivolumab in Combination With BMS-986253 or Cabiralizumab in Advanced Hepatocellular Carcinoma (HCC) Patients||Active, not recruiting||USA||0|
|NCT03336216||Phase II||Cabiralizumab + Gemcitabine + Nab-paclitaxel + Nivolumab Cabiralizumab + Nivolumab Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Cabiralizumab + Fluorouracil + Irinotecan + Leucovorin + Nivolumab||A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer||Active, not recruiting||USA | ITA | ESP | DEU | CAN||6|
|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||Completed||USA||0|
|NCT03927105||Phase II||Cabiralizumab + Nivolumab||Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma||Active, not recruiting||USA||0|
|NCT03768531||Phase II||Cabiralizumab + Nivolumab Nivolumab||Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer||Withdrawn||0|
|NCT03431948||Phase I||Nivolumab + Urelumab Cabiralizumab + Nivolumab||Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer (C4 MOSART)||Active, not recruiting||USA||0|