Therapy Detail

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Therapy Name Cabiralizumab + Nivolumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cabiralizumab FPA008|FPA-008|FPA 008|BMS-986227 CSF1R Antibody 5 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 148 PD-L1/PD-1 antibody 117 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 (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), 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 for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03768531 Phase II Cabiralizumab + Nivolumab Nivolumab Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer Withdrawn 0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 Completed USA | ITA | GBR | ESP | DEU | CAN 5
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
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 Completed USA 0
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
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
NCT03431948 Phase I Nivolumab + Urelumab Cabiralizumab + Nivolumab Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer (C4 MOSART) Completed 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


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