Therapy Detail
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| Therapy Name | Cemiplimab + Fianlimab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cemiplimab | Libtayo | REGN2810|SAR439684 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov). |
| Fianlimab | REGN 3767|R3767|REGN3767 | Immune Checkpoint Inhibitor 149 LAG3 Antibody 18 | Fianlimab (REGN3767 ) is a monoclonal antibody that targets LAG3, potentially resulting in increased anti-tumor immune response (PMID: 31395688). |
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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 |
|---|---|---|---|---|---|---|
| NCT05785767 | Phase II | Cemiplimab Cemiplimab + Fianlimab | A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | TUR | ISR | CAN | AUS | 5 |
| NCT05352672 | Phase III | Cemiplimab Cemiplimab + Fianlimab Pembrolizumab | Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | Recruiting | USA | TUR | ROU | POL | NLD | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 5 |
| NCT06205836 | Phase II | Cemiplimab Cemiplimab + Fianlimab | Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer | Recruiting | USA | 0 |
| NCT06161441 | Phase II | Carboplatin + Cemiplimab + Pemetrexed Disodium Carboplatin + Cemiplimab + Paclitaxel Cemiplimab + Fianlimab Cemiplimab + Cisplatin + Paclitaxel Cemiplimab + Cisplatin + Pemetrexed Disodium Cemiplimab + Cisplatin + Fianlimab + Pemetrexed Disodium Carboplatin + Cemiplimab + Fianlimab + Pemetrexed Disodium Carboplatin + Cemiplimab + Fianlimab + Paclitaxel Cemiplimab + Cisplatin + Fianlimab + Paclitaxel | A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery | Recruiting | USA | AUS | 2 |
| NCT01042379 | Phase II | Trilaciclib Trastuzumab Duocarmazine Cyclophosphamide + Doxorubicin Cemiplimab Amcenestrant Abemaciclib + Amcenestrant Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel + Trastuzumab Amcenestrant + Letrozole Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel Pertuzumab + Trastuzumab + Trilaciclib Paclitaxel + Trastuzumab Pertuzumab + Trastuzumab Cemiplimab + Fianlimab | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY) | Recruiting | USA | 0 |
| NCT05608291 | Phase III | Pembrolizumab Cemiplimab + Fianlimab | A Study to Evaluate the Superiority of the Fianlimab and Cemiplimab Combination Compared to Pembrolizumab in Adult and Adolescent Patients With Completely Resected High-Risk Skin Cancer | Recruiting | USA | TUR | ROU | POL | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 4 |
| NCT06246916 | Phase III | Cemiplimab + Fianlimab Nivolumab + Relatlimab | A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma | Recruiting | USA | 0 |
| NCT03005782 | Phase I | Cemiplimab + Fianlimab Fianlimab | Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers | Completed | USA | IRL | GBR | AUS | 1 |
| NCT06190951 | Phase II | Pembrolizumab Cemiplimab Cemiplimab + Fianlimab | A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma | Recruiting | USA | 0 |
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