Therapy Detail
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| Therapy Name | Durvalumab + Monalizumab |
| Synonyms | |
| Therapy Description |
Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, 28214651). Imfinzi (durvalumab) is FDA approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Durvalumab | Imfinzi | MEDI4736 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 129 | Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with unresectable, stage III non-small cell lung cancer, and limited-stage small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer, in combination with cisplatin plus gemcitabine followed by single-agent Imfinzi (durvalumab) in adult patients with muscle invasive bladder cancer (FDA.gov). |
| Monalizumab | NN-8765|IPH-2201|IPH 2201|IPH2201 | NKG2A Antibody 4 | Monalizumab (IPH2201) is a humanized monoclonal antibody against NKG2A that blocks NKG2A ligand binding, which in turn induces cell-mediated immune response against cancer cells (PMID: 30503213, PMID: 31623687, PMID: 31308062). |
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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 |
|---|---|---|---|---|---|---|
| NCT03794544 | Phase II | Durvalumab + Oleclumab Danvatirsen + Durvalumab Durvalumab Durvalumab + Monalizumab | Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer | Completed | USA | ITA | FRA | ESP | CHE | CAN | 1 |
| NCT03088059 | Phase II | Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil | Biomarker-based Study in R/M SCCHN (UPSTREAM) | Active, not recruiting | ITA | GBR | FRA | ESP | BEL | 0 |
| NCT05221840 | Phase III | Durvalumab + Oleclumab Durvalumab Durvalumab + Monalizumab | A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9) | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 11 |
| NCT03833440 | Phase II | Ceralasertib + Durvalumab Durvalumab + Oleclumab Docetaxel Durvalumab + Monalizumab | Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR) | Active, not recruiting | FRA | 0 |
| NCT05061550 | Phase II | Durvalumab + Monalizumab Durvalumab + Oleclumab | Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2) | Recruiting | USA | TUR | ITA | IRL | HUN | FRA | ESP | CAN | BEL | 3 |
| NCT03822351 | Phase II | Durvalumab Durvalumab + Monalizumab Durvalumab + Oleclumab | Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC (COAST) | Completed | USA | POL | ITA | FRA | ESP | CAN | 3 |
| NCT03801902 | Phase I | Durvalumab + Monalizumab Durvalumab | Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), ARCHON-1 Trial | Active, not recruiting | USA | 0 |
| NCT06503614 | Phase II | Durvalumab + Monalizumab | A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer (ENHANCE) | Recruiting | USA | 0 |
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