Therapy Detail
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| Therapy Name | BCG solution + Nivolumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| BCG solution | TICE BCG solution | Bacillus Calmette-Guerin solution | TICE BCG solution (BCG solution) is an attenuated live culture of Bacillus Calmette Guerin that induces anti-tumor immunity in bladder cancer (PMID: 26000263). TICE BCG solution (BCG solution) is FDA approved for carcinoma in situ of the bladder (FDA.gov). | |
| Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | 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 |
|---|---|---|---|---|---|---|
| NCT04149574 | Phase III | BCG solution + Nivolumab BCG solution | A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (CheckMate 7G8) | Terminated | USA | SWE | NLD | ITA | ISR | GRC | FRA | ESP | DEU | CAN | BRA | AUT | AUS | ARG | 3 |
| 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 | NLD | ITA | GBR | FRA | ESP | CAN | BRA | AUS | ARG | 5 |
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