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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 150 PD-L1/PD-1 antibody 132 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 150 LAG3 Antibody 19 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

Filtering

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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 | ESP | CAN | AUS 5
NCT06190951 Phase II 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 | ITA | FRA | ESP | DEU | CAN | AUS 0
NCT07223541 Phase II Cemiplimab Cemiplimab + Fianlimab Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma (LAG-BOOST) Not yet recruiting USA 0
NCT06887088 Phase II Cemiplimab + Fianlimab Binimetinib + Encorafenib Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases (ENCEFALO) Recruiting ESP 0
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 (Harmony Head-to-Head) Recruiting USA | CAN 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 Active, not recruiting USA | TUR | ROU | POL | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG 4
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
NCT06865339 Phase II Cemiplimab + Fianlimab Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer (TRIPL) Recruiting USA 0
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
NCT06918132 Phase II Cemiplimab + Fianlimab Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer (N-PLANC) 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
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 | TUR | ROU | ITA | FRA | ESP | DEU | AUS 5
NCT06699602 Phase II Cemiplimab + Fianlimab A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma Recruiting USA 0


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