A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
- Registration Number
- NCT03656718
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
-
Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
- Metastatic squamous or non-squamous NSCLC
- RCC, advanced or metastatic
- Melanoma
- HCC
- CRC, metastatic (MSI-H or dMMR)
- In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
- In Part E, Metastatic urothelial carcinoma
-
Measurable disease as per RECIST version 1.1 criteria
-
ECOG performance status of 0 or 1
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part C: nivolumab (dose 3) + rHuPH20 nivolumab - Part B, Group 3: nivolumab (dose 2) + rHuPH20 rHuPH20 - Part D, Group 5: nivolumab (dose 3) + rHuPH20 rHuPH20 - Part A, Group 1: nivolumab (dose 1) + rHuPH20 nivolumab - Part A, Group 1: nivolumab (dose 1) + rHuPH20 rHuPH20 - Part C: nivolumab (dose 3) + rHuPH20 rHuPH20 - Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20 rHuPH20 - Part D, Group 5: nivolumab (dose 3) + rHuPH20 nivolumab - Part B, Group 3: nivolumab (dose 2) + rHuPH20 nivolumab - Part B, Group 2: nivolumab (dose 1) nivolumab - Part B, Group 4: nivolumab (dose 2) nivolumab - Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20 nivolumab -
- Primary Outcome Measures
Name Time Method Time of maximum observed serum concentration (Tmax) Approximately 4 years Observed serum concentration at the end of a dosing interval (Ctau) Approximately 4 years Trough observed serum nivolumab concentration (Ctrough) Approximately 4 years Maximum observed serum concentration (Cmax) Approximately 4 years Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] Approximately 4 years
- Secondary Outcome Measures
Name Time Method Incidence of TRAEs leading to discontinuation Approximately 4 years Incidence of AEs leading to laboratory abnormalities Approximately 4 years Incidence of TRAEs leading to deaths Approximately 4 years Incidence of clinically significant changes in clinical laboratory values: Hematology tests Approximately 4 years Number of Clinically Significant Changes in Lab Assessment of: Urine Approximately 4 years Incidence of events within the hypersensitivity/infusion reaction select AE category Approximately 4 years Incidence of AEs leading to deaths Approximately 4 years Incidence of AEs leading to discontinuation Approximately 4 years Incidence of Adverse Events (AEs) Approximately 4 years Incidence of death Approximately 4 years Incidence of clinically significant changes in clinical laboratory values: Chemistry tests Approximately 4 years Number of Clinically Significant Changes in Lab Assessment of: Blood Serum Approximately 4 years Incidence of neutralizing antibodies Approximately 4 years Incidence of Treatment Related AEs (TRAEs) Approximately 4 years Incidence of TRAEs leading to laboratory abnormalities Approximately 4 years Incidence of anti-nivolumab antibodies Approximately 4 years Incidence of Serious Adverse Events (SAEs) Approximately 4 years Incidence of Treatment Related SAEs (TRSAEs) Approximately 4 years Incidence of clinically significant changes in clinical laboratory values: Serology tests Approximately 4 years Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction Approximately 4 years
Trial Locations
- Locations (36)
Local Institution - 0012
🇺🇸Eugene, Oregon, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Local Institution - 0011
🇺🇸Tyler, Texas, United States
Local Institution - 0035
🇦🇷Caba, Argentina
Local Institution - 0025
🇦🇷Caba, Argentina
Local Institution - 0010
🇺🇸Austin, Texas, United States
Local Institution - 0009
🇺🇸Beaumont, Texas, United States
Local Institution - 0007
🇺🇸Dallas, Texas, United States
Local Institution - 0038
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0037
🇧🇷Sao Paulo, Brazil
Local Institution - 0005
🇨🇱Santiago, Chile
Local Institution - 0022
🇫🇷Saint Herblain, France
Local Institution - 0048
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0046
🇲🇽Monterrey, Nuevo León, Mexico
Local Institution - 0021
🇫🇷Villejuif, France
Local Institution - 0003
🇮🇹Rozzano, MI, Italy
Local Institution - 0004
🇮🇹Padova, Italy
Local Institution - 0050
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0047
🇲🇽Monterrey, Nuevo León, Mexico
Local Institution - 0049
🇲🇽Puebla, Mexico
Local Institution - 0018
🇳🇿Newtown, Wellington, New Zealand
Local Institution - 0014
🇳🇿Dunedin, New Zealand
Local Institution - 0045
🇲🇽Querétaro, Mexico
Local Institution - 0026
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0039
🇳🇱Maastricht, Netherlands
Local Institution - 0040
🇳🇿Rotorua, Bay Of Plenty, New Zealand
Local Institution - 0015
🇳🇿Tauranga, New Zealand
Local Institution - 0019
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0016
🇪🇸Malaga, Spain
Local Institution - 0033
🇬🇧Cardiff, Glamorgan, United Kingdom
Local Institution - 0031
🇬🇧Liverpool, United Kingdom
Local Institution - 0017
🇪🇸Madrid, Spain
Winship Cancer Institute.
🇺🇸Atlanta, Georgia, United States
Local Institution - 0020
🇺🇸Detroit, Michigan, United States
Local Institution - 0001
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0024
🇺🇸Rockville, Maryland, United States