Clinical Trial: NCT03656718 - My Cancer Genome

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 Clinical Trial Physician - In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

Related Conditions:

Colorectal Carcinoma
Hepatocellular Carcinoma
Melanoma
Non-Small Cell Lung Carcinoma
Renal Cell Carcinoma
Urothelial Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03656718

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

Drug	Synonyms	Arms
nivolumab	Opdivo, BMS-986298	Part A, Group 1: nivolumab (dose 1) + rHuPH20
rHuPH20	ENHANZE™ DP	Part A, Group 1: nivolumab (dose 1) + rHuPH20
nivolumab	BMS-936558	Part A, Group 1: nivolumab (dose 1) + rHuPH20

Purpose

Trial Arms

Name	Type	Interventions
Part A, Group 1: nivolumab (dose 1) + rHuPH20	Experimental	nivolumab rHuPH20 nivolumab
Part B, Group 3: nivolumab (dose 2) + rHuPH20	Experimental	nivolumab rHuPH20 nivolumab
Part B, Group 2: nivolumab (dose 1)	Experimental	nivolumab nivolumab
Part B, Group 4: nivolumab (dose 2)	Experimental	nivolumab nivolumab
Part C: nivolumab (dose 3) + rHuPH20	Experimental	nivolumab rHuPH20
Part D, Group 5: nivolumab (dose 3) + rHuPH20	Experimental	nivolumab rHuPH20
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20	Experimental	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

               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 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 4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Incidence of Adverse Events (AEs)
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of AEs leading to deaths
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of AEs leading to laboratory abnormalities
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of AEs leading to discontinuation
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of Treatment Related AEs (TRAEs)
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of TRAEs leading to laboratory abnormalities
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of TRAEs leading to discontinuation
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of TRAEs leading to deaths
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of Serious Adverse Events (SAEs)
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of Treatment Related SAEs (TRSAEs)
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of death
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of clinically significant changes in clinical laboratory values: Serology tests
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Number of Clinically Significant Changes in Lab Assessment of: Blood Serum
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Number of Clinically Significant Changes in Lab Assessment of: Urine
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of events within the hypersensitivity/infusion reaction select AE category
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of anti-nivolumab antibodies
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Measure:	Incidence of neutralizing antibodies
Time Frame:	Approximately 4 years
Safety Issue:
Description:

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Bristol-Myers Squibb

Trial Keywords

Subcutaneous
Nivolumab
rHuPH20

Last Updated

August 3, 2021

Clinical Trials /

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