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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2025
  • participants needed
    170
  • sponsor
    Bristol-Myers Squibb
Updated on 7 October 2022
carcinoma
primary cancer
solid tumor

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).

Details
Condition Neoplasms by Site
Treatment Nivolumab, rHuPH20
Clinical Study IdentifierNCT03656718
SponsorBristol-Myers Squibb
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types
Metastatic squamous or non-squamous NSCLC
RCC, advanced or metastatic
Melanoma
HCC
CRC, metastatic (MSI-H or dMMR)
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
In Part E, Metastatic urothelial carcinoma
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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