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Therapy Name Retifanlimab
Synonyms
Therapy Description

Zynyz (retifanlimab) is a humanized IgG4 monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT085). Zynyz (retifanlimab) is FDA approved for use in adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Retifanlimab Zynyz MGA 012|INCMGA00012|MGA012|retifanlimab-dlwr Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 Zynyz (retifanlimab) is a humanized IgG4 monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT085). Zynyz (retifanlimab) is FDA approved for use in adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (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
NCT03059823 Phase I Retifanlimab A Phase 1 Study of MGA012 in Patients With Advanced Solid Tumors Completed USA | POL | NZL | LVA | LTU | ITA | GBR | FRA | FIN | ESP | DEU | BGR | BEL | AUS 2
NCT03599713 Phase II Retifanlimab A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma Completed USA | POL | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUS 0
NCT03679767 Phase II Retifanlimab A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) Completed USA | ROU | POL | ITA | HUN | FRA | ESP | AUT 0
NCT05083754 Phase I Retifanlimab Temozolomide Retifanlimab + Temozolomide Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma Recruiting USA 0
NCT04205812 Phase III Retifanlimab Pemetrexed Disodium Carboplatin + Nab-paclitaxel Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium + Retifanlimab Carboplatin + Nab-paclitaxel + Retifanlimab Cisplatin + Pemetrexed Disodium + Retifanlimab Pemetrexed Disodium + Retifanlimab Carboplatin + Pemetrexed Disodium Carboplatin + Paclitaxel + Retifanlimab Carboplatin + Paclitaxel Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (POD1UM-304) Active, not recruiting USA | TUR | ROU | POL | HUN | CZE | BRA | BGR 9
NCT05287113 Phase II INCAGN02385 + Retifanlimab Retifanlimab INCAGN02385 + INCAGN02390 + Retifanlimab Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS >= 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Active, not recruiting USA | POL | NLD | ITA | GRC | FRA | ESP | DEU | CAN | BEL 4
NCT04116073 Phase II Retifanlimab INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer Completed USA 0
NCT04463771 Phase II Pemigatinib + Retifanlimab Epacadostat + Retifanlimab Retifanlimab Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (POD1UM-204) Active, not recruiting USA | ITA | GRC | FRA | DEU | BEL 1
NCT03597295 Phase II Retifanlimab A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy Completed USA | NOR | ITA | GBR | FRA | ESP | DNK | DEU | BEL 0
NCT04586244 Phase II Retifanlimab Epacadostat + Retifanlimab Epacadostat An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (Optimus) Terminated USA | ITA | FRA 0


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