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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03656718
Collaborator
(none)
170
Enrollment
33
Locations
7
Arms
80.4
Anticipated Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
Actual Study Start Date :
Oct 31, 2018
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Jul 14, 2025

Arms and Interventions

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

    		•
    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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed serum concentration (Cmax) [Approximately 4 years]

    2. Time of maximum observed serum concentration (Tmax) [Approximately 4 years]

    3. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [Approximately 4 years]

    4. Observed serum concentration at the end of a dosing interval (Ctau) [Approximately 4 years]

    5. Trough observed serum nivolumab concentration (Ctrough) [Approximately 4 years]

    Secondary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Approximately 4 years]

    2. Incidence of AEs leading to deaths [Approximately 4 years]

    3. Incidence of AEs leading to laboratory abnormalities [Approximately 4 years]

    4. Incidence of AEs leading to discontinuation [Approximately 4 years]

    5. Incidence of Treatment Related AEs (TRAEs) [Approximately 4 years]

    6. Incidence of TRAEs leading to laboratory abnormalities [Approximately 4 years]

    7. Incidence of TRAEs leading to discontinuation [Approximately 4 years]

    8. Incidence of TRAEs leading to deaths [Approximately 4 years]

    9. Incidence of Serious Adverse Events (SAEs) [Approximately 4 years]

    10. Incidence of Treatment Related SAEs (TRSAEs) [Approximately 4 years]

    11. Incidence of death [Approximately 4 years]

    12. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [Approximately 4 years]

    13. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [Approximately 4 years]

    14. Incidence of clinically significant changes in clinical laboratory values: Serology tests [Approximately 4 years]

    15. Number of Clinically Significant Changes in Lab Assessment of: Blood Serum [Approximately 4 years]

    16. Number of Clinically Significant Changes in Lab Assessment of: Urine [Approximately 4 years]

    17. Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction [Approximately 4 years]

    18. Incidence of events within the hypersensitivity/infusion reaction select AE category [Approximately 4 years]

    19. Incidence of anti-nivolumab antibodies [Approximately 4 years]

    20. Incidence of neutralizing antibodies [Approximately 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Winship Cancer Institute. Atlanta Georgia United States 30322
    2 Maryland Oncology Hematology, P.A. Rockville Maryland United States 20850
    3 Karmanos Cancer Institute Detroit Michigan United States 48201-2014
    4 Local Institution Minneapolis Minnesota United States 55455
    5 Levine Cancer Institute Charlotte North Carolina United States 28204
    6 Willamette Valley Cancer Institute And Research Center Eugene Oregon United States 97401
    7 Local Institution Greenville South Carolina United States 29605
    8 Texas Oncology- Austin Midtown Austin Texas United States 78705
    9 Texas Oncology-Beaumont Beaumont Texas United States 77702-1449
    10 Texas Oncology - Baylor Charles A. Simmons Cancer Center Dallas Texas United States 75246
    11 Uus Oncology Tyler Texas United States 75702
    12 Local Institution - 0035 Caba Argentina 1199
    13 Local Institution - 0025 Caba Argentina 1426
    14 Local Institution Porto Alegre RIO Grande DO SUL Brazil 90610-000
    15 Local Institution - 0037 Sao Paulo Brazil 05651-901
    16 Local Institution Santiago Metropolitana Chile
    17 Local Institution - 0005 Santiago Chile 0
    18 Institut De Cancerologie De L Ouest Saint Herblain France 44805
    19 Local Institution - 0021 Villejuif France 94805
    20 Local Institution - 0004 Padova Italy 35128
    21 Local Institution - 0003 Rozzano Italy 20089
    22 Local Institution - 0026 Amsterdam Netherlands 1066 CX
    23 Local Institution - 0039 Maastricht Netherlands 6229 HX
    24 Local Institution - 0018 Newtown Wellington New Zealand 6021
    25 Local Institution - 0014 Dunedin New Zealand 9012
    26 Local Institution - 0015 Tauranga New Zealand 3112
    27 Local Institution - 0019 Warszawa Mazowieckie Poland 02-781
    28 Local Institution - 0017 Madrid Spain 28007
    29 Hospital Universitario Virgen De La Victoria Malaga Spain 29010
    30 Local Institution Cardiff Glamorgan United Kingdom CF14 2TL
    31 Local Institution Cambridge United Kingdom CB2 0QQ
    32 Local Institution Leicester United Kingdom LE3 9QP
    33 Local Institution - 0031 Liverpool United Kingdom L7 8YA

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03656718
    Other Study ID Numbers:
    • CA209-8KX
    • 2018-001585-42
    First Posted:
    Sep 4, 2018
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 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
    Nivolumab

    Study Results

    No Results Posted as of Jul 20, 2022