{"id":"mk-3475a","safety":{"commonSideEffects":[{"rate":"20–30","effect":"Fatigue"},{"rate":"15–25","effect":"Diarrhea"},{"rate":"10–20","effect":"Nausea"},{"rate":"10–15","effect":"Decreased appetite"},{"rate":"3–5","effect":"Immune-mediated pneumonitis"},{"rate":"2–4","effect":"Immune-mediated colitis"},{"rate":"1–3","effect":"Immune-mediated hepatitis"},{"rate":"5–10","effect":"Immune-mediated endocrinopathy"}]},"_chembl":{"chemblId":"CHEMBL2057618","moleculeType":"Small molecule","molecularWeight":"164.16"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting the PD-1 checkpoint, MK-3475A prevents tumor cells from suppressing T cell activity, allowing the immune system to recognize and attack cancer cells more effectively. This mechanism restores exhausted T cell function and promotes durable anti-tumor immunity. The drug is designed as a next-generation or optimized variant of pembrolizumab (MK-3475).","oneSentence":"MK-3475A is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and its ligands, thereby enhancing anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:21:39.994Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic melanoma"},{"name":"Non-small cell lung cancer"},{"name":"Head and neck squamous cell carcinoma"},{"name":"Hodgkin lymphoma"},{"name":"Gastric or gastroesophageal junction adenocarcinoma"}]},"trialDetails":[{"nctId":"NCT05017012","phase":"PHASE1","title":"A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme 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Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-10-20","conditions":"Squamous Cell Carcinoma","enrollment":19},{"nctId":"NCT06698042","phase":"PHASE3","title":"A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-11-21","conditions":"Lung Cancer, Non-Small Cell Lung Cancer","enrollment":67},{"nctId":"NCT06504394","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-10-14","conditions":"Classical Hodgkin Lymphoma Recurrent, Classical Hodgkin Lymphoma Refractory, Primary Mediastinal Large B-cell Lymphoma Recurrent","enrollment":66},{"nctId":"NCT06212752","phase":"PHASE3","title":"A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-06-13","conditions":"Metastatic Non-small Cell Lung Cancer","enrollment":39},{"nctId":"NCT05722015","phase":"PHASE3","title":"A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme 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Melanoma","enrollment":147}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pembrolizumab (+) Berahyaluronidase alfa"],"phase":"phase_3","status":"active","brandName":"MK-3475A","genericName":"MK-3475A","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"MK-3475A is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and its ligands, thereby enhancing anti-tumor immune responses. Used for Advanced or metastatic melanoma, Non-small cell lung cancer, Head and neck squamous cell carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}