{"id":"nivolumab-and-rhuph20","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Nivolumab is a PD-1 checkpoint inhibitor that prevents tumor cells from suppressing T-cell responses. rHuPH20 is an enzyme that breaks down hyaluronic acid in the tumor microenvironment, reducing physical barriers to drug and immune cell infiltration. This combination aims to improve nivolumab's efficacy by increasing its intratumoral concentration and facilitating immune cell access to cancer cells.","oneSentence":"Nivolumab blocks PD-1 on immune cells to restore anti-tumor immunity, while rHuPH20 (recombinant human hyaluronidase) enhances drug penetration into tumors by degrading the hyaluronic acid-rich extracellular matrix.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:11.162Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT07383441","phase":"PHASE3","title":"Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer","status":"NOT_YET_RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2026-06-10","conditions":"Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8","enrollment":718},{"nctId":"NCT06697197","phase":"PHASE1, PHASE2","title":"A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-02-17","conditions":"Advanced Solid Tumors","enrollment":413},{"nctId":"NCT03656718","phase":"PHASE1, PHASE2","title":"A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2018-10-29","conditions":"Neoplasms by Site","enrollment":139},{"nctId":"NCT04810078","phase":"PHASE3","title":"A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2021-05-21","conditions":"Clear Cell Renal Cell Carcinoma","enrollment":681},{"nctId":"NCT03446040","phase":"PHASE1, PHASE2","title":"An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread","status":"TERMINATED","sponsor":"Bristol-Myers Squibb","startDate":"2018-03-08","conditions":"Advanced Cancer","enrollment":92},{"nctId":"NCT05625399","phase":"PHASE3","title":"A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2023-03-06","conditions":"Melanoma","enrollment":579},{"nctId":"NCT06101134","phase":"PHASE2","title":"A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2023-11-06","conditions":"Melanoma","enrollment":100},{"nctId":"NCT05297565","phase":"PHASE3","title":"A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2022-08-02","conditions":"Melanoma","enrollment":14},{"nctId":"NCT05496192","phase":"PHASE2","title":"A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer","status":"WITHDRAWN","sponsor":"Bristol-Myers Squibb","startDate":"2023-05-31","conditions":"Melanoma, Urothelial Carcinoma","enrollment":""},{"nctId":"NCT04112498","phase":"PHASE1","title":"A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2019-10-01","conditions":"Cancer","enrollment":24},{"nctId":"NCT02754141","phase":"PHASE1, PHASE2","title":"An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2016-06-21","conditions":"Malignant Solid Tumor","enrollment":235},{"nctId":"NCT04311710","phase":"PHASE1","title":"A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types","status":"TERMINATED","sponsor":"Bristol-Myers Squibb","startDate":"2020-06-25","conditions":"Tumor","enrollment":21}],"_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":["BMS-986298"],"phase":"phase_3","status":"active","brandName":"Nivolumab and rHuPH20","genericName":"Nivolumab and rHuPH20","companyName":"Bristol-Myers Squibb","companyId":"bristol-myers-squibb","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nivolumab blocks PD-1 on immune cells to restore anti-tumor immunity, while rHuPH20 (recombinant human hyaluronidase) enhances drug penetration into tumors by degrading the hyaluronic acid-rich extracellular matrix. Used for Advanced or metastatic solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}