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
rHuPH20ENHANZE™ DPSC 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) - in Part B, other solid tumors may be considered at the discretion of the Medical Monitor

Trial Arms

NameTypeDescriptionInterventions
SC nivolumabExperimental
  • Nivolumab
  • rHuPH20
SC nivolumab with rHuPH20Experimental
  • Nivolumab
  • 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)

               6. In Part B, other solid tumor types may be considered at the discretion of the
                  Medical Monitor

          -  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:
Measure:Incidence of AEs in the broad SMO of Anaphylactic Reaction
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:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

August 7, 2019