{"id":"pembrolizumab-with-optional-crossover-period","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Fatigue"},{"rate":"15-25","effect":"Decreased appetite"},{"rate":"10-20","effect":"Nausea"},{"rate":"10-20","effect":"Diarrhea"},{"rate":"10-20","effect":"Rash"},{"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)"},{"rate":"1-2","effect":"Immune-mediated nephritis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pembrolizumab is a humanized monoclonal antibody that binds to programmed death receptor-1 (PD-1) on T cells, preventing interaction with its ligands PD-L1 and PD-L2 expressed on tumor cells and immune cells. This blockade restores T cell activation, proliferation, and effector function, enabling the immune system to mount an anti-tumor response. The optional crossover period in this trial design allows control-arm patients to receive pembrolizumab if the primary endpoint is met.","oneSentence":"Pembrolizumab blocks PD-1 on immune cells to release the brakes on anti-tumor immunity, allowing T cells to recognize and attack cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:48:32.027Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Melanoma (advanced or metastatic)"},{"name":"Non-small cell lung cancer (advanced or metastatic)"},{"name":"Head and neck squamous cell carcinoma"},{"name":"Hodgkin lymphoma (relapsed or refractory)"},{"name":"Urothelial carcinoma (advanced or metastatic)"},{"name":"Gastric or gastroesophageal junction adenocarcinoma"},{"name":"Cervical cancer (advanced or recurrent)"},{"name":"Renal cell carcinoma (advanced)"},{"name":"Hepatocellular carcinoma"},{"name":"Microsatellite instability-high or mismatch repair-deficient solid tumors"}]},"trialDetails":[{"nctId":"NCT05727904","phase":"PHASE3","title":"Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.","status":"RECRUITING","sponsor":"Iovance Biotherapeutics, Inc.","startDate":"2023-03-30","conditions":"Metastatic Melanoma, Unresectable Melanoma, Melanoma","enrollment":670}],"_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":[],"phase":"phase_3","status":"active","brandName":"Pembrolizumab with Optional Crossover Period","genericName":"Pembrolizumab with Optional Crossover Period","companyName":"Iovance Biotherapeutics, Inc.","companyId":"iovance-biotherapeutics-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Pembrolizumab blocks PD-1 on immune cells to release the brakes on anti-tumor immunity, allowing T cells to recognize and attack cancer cells. Used for Melanoma (advanced or metastatic), Non-small cell lung cancer (advanced or metastatic), Head and neck squamous cell carcinoma.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}