{"id":"pembrolizumab-formulated-with-berahyaluronidase-alfa","safety":{"commonSideEffects":[{"rate":"30-40","effect":"Fatigue"},{"rate":"20-30","effect":"Diarrhea"},{"rate":"20-25","effect":"Nausea"},{"rate":"15-20","effect":"Decreased appetite"},{"rate":"15-20","effect":"Rash"},{"rate":"10-15","effect":"Pruritus"},{"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 (thyroiditis, adrenalitis)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pembrolizumab is a PD-1 checkpoint inhibitor that prevents tumor cells from suppressing T-cell responses, thereby reactivating the immune system to attack cancer. Berahyaluronidase alfa is a recombinant human hyaluronidase that transiently breaks down hyaluronic acid in the subcutaneous space, increasing the bioavailability and absorption of co-administered pembrolizumab, allowing for subcutaneous administration instead of intravenous infusion.","oneSentence":"Pembrolizumab blocks PD-1 on immune cells to restore anti-tumor immunity, while berahyaluronidase alfa enhances subcutaneous drug delivery by temporarily degrading hyaluronic acid in tissue.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:48:22.006Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Melanoma (advanced or metastatic)"},{"name":"Non-small cell lung cancer (metastatic, PD-L1 positive)"},{"name":"Head and neck squamous cell carcinoma"},{"name":"Hodgkin lymphoma (classical, relapsed or refractory)"},{"name":"Gastric or gastroesophageal junction adenocarcinoma"},{"name":"Cervical cancer"},{"name":"Renal cell carcinoma"},{"name":"Endometrial carcinoma"},{"name":"Microsatellite instability-high or mismatch repair-deficient solid tumors"}]},"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 LLC","startDate":"2021-09-21","conditions":"Advanced or Metastatic Solid Tumors","enrollment":72},{"nctId":"NCT06041802","phase":"PHASE2","title":"A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or 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":"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 LLC","startDate":"2023-02-14","conditions":"Metastatic Non-small Cell Lung Cancer","enrollment":377}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["MK-3475A"],"phase":"phase_3","status":"active","brandName":"Pembrolizumab Formulated with Berahyaluronidase Alfa","genericName":"Pembrolizumab Formulated with Berahyaluronidase Alfa","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"Pembrolizumab blocks PD-1 on immune cells to restore anti-tumor immunity, while berahyaluronidase alfa enhances subcutaneous drug delivery by temporarily degrading hyaluronic acid in tissue. Used for Melanoma (advanced or metastatic), Non-small cell lung cancer (metastatic, PD-L1 positive), Head and neck squamous cell carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}