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

December 6, 2023 updated by: Bristol-Myers Squibb

Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, 1199
        • Local Institution - 0035
      • Caba, Argentina, 1426
        • Local Institution - 0025
  • Brazil
      • Sao Paulo, Brazil, 05651-901
        • Local Institution - 0037
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90610000
        • Local Institution - 0038
  • Chile
      • Santiago, Chile
        • Local Institution - 0005
  • France
      • Saint Herblain, France, 44805
        • Local Institution - 0022
      • Villejuif, France, 94805
        • Local Institution - 0021
  • Italy
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IOV
      • Rozzano, Italy, 20089
        • Local Institution - 0003
  • Mexico
      • Puebla, Mexico, 72424
        • Local Institution - 0049
      • Querétaro, Mexico, 76000
        • Local Institution - 0045
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Local Institution - 0048
      • Mexico City, Distrito Federal, Mexico, 03100
        • Local Institution - 0050
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • Local Institution - 0046
      • Monterrey, Nuevo León, Mexico, 66460
        • Local Institution - 0047
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0026
      • Maastricht, Netherlands, 6229 HX
        • Local Institution - 0039
  • New Zealand
      • Dunedin, New Zealand, 9012
        • Local Institution - 0014
      • Tauranga, New Zealand, 3112
        • Local Institution - 0015
    • Bay Of Plenty
      • Rotorua, Bay Of Plenty, New Zealand, 3046
        • Local Institution - 0040
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Local Institution - 0018
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Local Institution - 0019
  • Spain
      • Madrid, Spain, 28007
        • Local Institution - 0017
      • Malaga, Spain, 29010
        • Local Institution - 0016
  • United Kingdom
      • Liverpool, United Kingdom, L7 8YA
        • Local Institution - 0031
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF14 2TL
        • Local Institution - 0033
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute.
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Local Institution - 0024
    • Michigan
      • Detroit, Michigan, United States, 48201-2014
        • Local Institution - 0020
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0001
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0012
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System
    • Texas
      • Austin, Texas, United States, 78705
        • Local Institution - 0010
      • Beaumont, Texas, United States, 77702-1449
        • Local Institution - 0009
      • Dallas, Texas, United States, 75246
        • Local Institution - 0007
      • Tyler, Texas, United States, 75702
        • Local Institution - 0011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:

    1. Metastatic squamous or non-squamous NSCLC
    2. RCC, advanced or metastatic
    3. Melanoma
    4. HCC
    5. CRC, metastatic (MSI-H or dMMR)
    6. In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
    7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Names:
  • ENHANZE™ DP
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558
Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Names:
  • ENHANZE™ DP
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558
Experimental: Part B, Group 2: nivolumab (dose 1)
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558
Experimental: Part B, Group 4: nivolumab (dose 2)
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558
Experimental: Part C: nivolumab (dose 3) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Names:
  • ENHANZE™ DP
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558
Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Names:
  • ENHANZE™ DP
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558
Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
Biological: nivolumab
(Subcutaneous) Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298
Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Names:
  • ENHANZE™ DP
Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Names:
  • BMS-936558

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration (Cmax)
Time Frame: Approximately 4 years
Approximately 4 years
Time of maximum observed serum concentration (Tmax)
Time Frame: Approximately 4 years
Approximately 4 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame: Approximately 4 years
Approximately 4 years
Observed serum concentration at the end of a dosing interval (Ctau)
Time Frame: Approximately 4 years
Approximately 4 years
Trough observed serum nivolumab concentration (Ctrough)
Time Frame: Approximately 4 years
Approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of AEs leading to deaths
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of AEs leading to laboratory abnormalities
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of AEs leading to discontinuation
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of Treatment Related AEs (TRAEs)
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of TRAEs leading to laboratory abnormalities
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of TRAEs leading to discontinuation
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of TRAEs leading to deaths
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of Serious Adverse Events (SAEs)
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of Treatment Related SAEs (TRSAEs)
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of death
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of clinically significant changes in clinical laboratory values: Serology tests
Time Frame: Approximately 4 years
Approximately 4 years
Number of Clinically Significant Changes in Lab Assessment of: Blood Serum
Time Frame: Approximately 4 years
Approximately 4 years
Number of Clinically Significant Changes in Lab Assessment of: Urine
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of events within the hypersensitivity/infusion reaction select AE category
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of anti-nivolumab antibodies
Time Frame: Approximately 4 years
Approximately 4 years
Incidence of neutralizing antibodies
Time Frame: Approximately 4 years
Approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2018

Primary Completion (Actual)

September 7, 2022

Study Completion (Estimated)

March 7, 2025

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8KX
  • 2018-001585-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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