Clinical Trials /

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

NCT03656718

Description:

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 Medical Monitor

Related Conditions:
  • Colorectal Carcinoma
  • Hepatocellular Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
  • Official Title: Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

Clinical Trial IDs

  • ORG STUDY ID: CA209-8KX
  • SECONDARY ID: 2018-001585-42
  • NCT ID: NCT03656718

Conditions

  • Neoplasms by Site

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-986298SC nivolumab
rHuPH20ENHANZESC nivolumab

Purpose

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)

Trial Arms

NameTypeDescriptionInterventions
SC nivolumabExperimental
  • rHuPH20
SC nivolumab with rHuPH20Experimental
  • rHuPH20

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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)

          -  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 could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum observed serum concentration (Cmax)
Time Frame:Approximately 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of death
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of clinical laboratory test abnormalities
Time Frame:Approximately 2 years
Safety Issue:
Description:On study laboratory parameters including hematology, chemistry, liver function, and renal function
Measure:Incidence of AEs in the MedDRA Anaphylactic Reaction broad scope SMQ
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of events within the hypersensitivity/infusion reaction select AE category
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies to nivolumab
Time Frame:Approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated