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Trial record 1 of 1 for:    NCT03656718
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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 : Recruiting
First Posted : September 3, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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)

Condition or disease Intervention/treatment Phase
Neoplasms by Site Biological: Nivolumab Drug: rHuPH20 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : September 24, 2018
Estimated Primary Completion Date : September 26, 2021
Estimated Study Completion Date : October 25, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: SC nivolumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298

Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Name: ENHANZE

Experimental: SC nivolumab with rHuPH20 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-986298

Drug: rHuPH20
Specified dose on specified days Permeation enhancer
Other Name: ENHANZE




Primary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 1 year ]
  2. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 1 year ]
  3. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 1 year ]
  4. Observed serum concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 1 year ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation [ Time Frame: Approximately 2 years ]
  2. Incidence of death [ Time Frame: Approximately 2 years ]
  3. Incidence of clinical laboratory test abnormalities [ Time Frame: Approximately 2 years ]
    On study laboratory parameters including hematology, chemistry, liver function, and renal function

  4. Incidence of AEs in the MedDRA Anaphylactic Reaction broad scope SMQ [ Time Frame: Approximately 2 years ]
  5. Incidence of events within the hypersensitivity/infusion reaction select AE category [ Time Frame: Approximately 2 years ]
  6. Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies to nivolumab [ Time Frame: Approximately 2 years ]


Information from the National Library of Medicine

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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

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


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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 30 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03656718     History of Changes
Other Study ID Numbers: CA209-8KX
2018-001585-42 ( EudraCT Number )
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms by Site
Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents