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A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

  • Clinicaltrials.gov identifier

    NCT03656718

  • Recruitment Status

    Recruiting

  • First Posted

    September 4, 2018

  • Last update posted

    September 9, 2022

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

  • Study Type: Interventional
  • Estimated Enrollment: 170 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: July 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Drug: rHuPH20
Specified dose on specified days Permeation enhancer

Biological: nivolumab
(IV) Specified Dose on Specified Days
Experimental: Part B, Group 2: nivolumab (dose 1)
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Biological: nivolumab
(IV) Specified Dose on Specified Days
Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Drug: rHuPH20
Specified dose on specified days Permeation enhancer

Biological: nivolumab
(IV) Specified Dose on Specified Days
Experimental: Part B, Group 4: nivolumab (dose 2)
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Biological: nivolumab
(IV) Specified Dose on Specified Days
Experimental: Part C: nivolumab (dose 3) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days

Drug: rHuPH20
Specified dose on specified days Permeation enhancer

Outcome Measures

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

Eligibility Criteria

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

Criteria

Inclusion Criteria: 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 Exclusion Criteria: Active brain metastases or leptomeningeal metastases Ocular melanoma Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 ClinicalTrials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Georgia
Winship Cancer Institute.
Atlanta

United States, Maryland
Maryland Oncology Hematology, P.A.
Rockville

United States, Michigan
Karmanos Cancer Institute
Detroit

United States, Minnesota
Local Institution
Minneapolis

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene

United States, South Carolina
Local Institution
Greenville

United States, Texas
Texas Oncology- Austin Midtown
Austin

United States, Texas
Texas Oncology-Beaumont
Beaumont

United States, Texas
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas

United States, Texas
Uus Oncology
Tyler

Argentina
Local Institution - 0043
Buenos Aires

Argentina
Local Institution - 0035
Caba

Argentina
Local Institution - 0025
Caba

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil
Local Institution - 0037
Sao Paulo

Chile, Metropolitana
Local Institution
Santiago

Chile, Región Metropolitana De Santiago
Local Institution - 0041
Santiago

Chile, Región Metropolitana De Santiago
Local Institution - 0042
Santiago

Chile
Local Institution - 0005
Santiago

France
Institut De Cancerologie De L Ouest
Saint Herblain

France
Local Institution - 0021
Villejuif

Italy
Local Institution - 0004
Padova

Italy
Local Institution - 0003
Rozzano

Mexico, Nuevo León
Local Institution - 0046
Monterrey

Mexico, Nuevo León
Local Institution - 0047
Monterrey

Mexico
Local Institution - 0045
Querétaro

Netherlands
Local Institution - 0026
Amsterdam

Netherlands
Local Institution - 0039
Maastricht

New Zealand, Wellington
Local Institution - 0018
Newtown

New Zealand
Local Institution - 0014
Dunedin

New Zealand
Local Institution - 0015
Tauranga

Poland, Mazowieckie
Local Institution - 0019
Warszawa

Spain
Local Institution - 0017
Madrid

Spain
Hospital Universitario Virgen De La Victoria
Malaga

United Kingdom, Glamorgan
Local Institution
Cardiff

United Kingdom
Local Institution
Cambridge

United Kingdom
Local Institution
Leicester

United Kingdom
Local Institution - 0031
Liverpool

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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: September 9, 2022
  • Last Verified: September 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