Study Description

Brief summary:

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: non-small cell lung cancer (NSCLC) renal cell carcinoma (RCC) unresectable or metastatic melanoma hepatocellular carcinoma (HCC) microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

• Condition or Disease:Neoplasms by Site
• Intervention/Treatment: Biological: nivolumab
  Drug: rHuPH20
  Biological: nivolumab
• Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 4 years ]
  
• Primary Outcome Measures: 2. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 4 years ]
  
• Primary Outcome Measures: 3. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 4 years ]
  
• Primary Outcome Measures: 4. Observed serum concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 4 years ]
  
• Primary Outcome Measures: 5. Trough observed serum nivolumab concentration (Ctrough) [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 2. Incidence of AEs leading to deaths [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 3. Incidence of AEs leading to laboratory abnormalities [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 5. Incidence of Treatment Related AEs (TRAEs) [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 6. Incidence of TRAEs leading to laboratory abnormalities [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 7. Incidence of TRAEs leading to discontinuation [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 8. Incidence of TRAEs leading to deaths [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 9. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 10. Incidence of Treatment Related SAEs (TRSAEs) [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 11. Incidence of death [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 12. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 13. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 14. Incidence of clinically significant changes in clinical laboratory values: Serology tests [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 15. Number of Clinically Significant Changes in Lab Assessment of: Blood Serum [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 16. Number of Clinically Significant Changes in Lab Assessment of: Urine [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 17. Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 18. Incidence of events within the hypersensitivity/infusion reaction select AE category [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 19. Incidence of anti-nivolumab antibodies [ Time Frame: Approximately 4 years ]
  
• Secondary Outcome Measures: 20. Incidence of neutralizing antibodies [ Time Frame: Approximately 4 years ]
  

Eligibility Criteria

Information from the National Library of Medicine

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• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03656718 History of Changes
• Other Study ID Numbers: CA209-8KX, 2018-001585-42
• First Posted: September 4, 2018 Key Record Dates
• Last Update Posted: May 9, 2022
• Last Verified: May 2022
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Subcutaneous
  Nivolumab rHuPH20
• Additional relevant MeSH terms: Neoplasms by Site Neoplasms