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

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ClinicalTrials.gov Identifier: NCT03656718
Recruitment Status : Active, not recruiting
First Posted : September 4, 2018
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
Neoplasms by Site Biological: nivolumab Drug: rHuPH20 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 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 : October 31, 2018
Actual Primary Completion Date : September 7, 2022
Estimated Study Completion Date : March 7, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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 Name: ENHANZE™ DP

Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Name: 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 Name: ENHANZE™ DP

Biological: nivolumab
(IV) Specified Dose on Specified Days
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: ENHANZE™ DP


Outcome Measures
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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 Adverse Events (AEs) [ Time Frame: Approximately 4 years ]
  2. Incidence of AEs leading to deaths [ Time Frame: Approximately 4 years ]
  3. Incidence of AEs leading to laboratory abnormalities [ Time Frame: Approximately 4 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
  5. Incidence of Treatment Related AEs (TRAEs) [ Time Frame: Approximately 4 years ]
  6. Incidence of TRAEs leading to laboratory abnormalities [ Time Frame: Approximately 4 years ]
  7. Incidence of TRAEs leading to discontinuation [ Time Frame: Approximately 4 years ]
  8. Incidence of TRAEs leading to deaths [ Time Frame: Approximately 4 years ]
  9. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 4 years ]
  10. Incidence of Treatment Related SAEs (TRSAEs) [ Time Frame: Approximately 4 years ]
  11. Incidence of death [ Time Frame: Approximately 4 years ]
  12. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Approximately 4 years ]
  13. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: Approximately 4 years ]
  14. Incidence of clinically significant changes in clinical laboratory values: Serology tests [ Time Frame: Approximately 4 years ]
  15. Number of Clinically Significant Changes in Lab Assessment of: Blood Serum [ Time Frame: Approximately 4 years ]
  16. Number of Clinically Significant Changes in Lab Assessment of: Urine [ Time Frame: Approximately 4 years ]
  17. Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction [ Time Frame: Approximately 4 years ]
  18. Incidence of events within the hypersensitivity/infusion reaction select AE category [ Time Frame: Approximately 4 years ]
  19. Incidence of anti-nivolumab antibodies [ Time Frame: Approximately 4 years ]
  20. Incidence of neutralizing antibodies [ Time Frame: Approximately 4 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

    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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656718


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03656718    
Other Study ID Numbers: CA209-8KX
2018-001585-42 ( EudraCT Number )
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023

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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:
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Neoplasms by Site
Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action