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

Neoplasms by Site Clinical Trial

Official title:

Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03656718
• Other study ID #: CA209-8KX
• Secondary ID: 2018-001585-42
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 31, 2018
• Est. completion date: March 7, 2025

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: March 7, 2025
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 apply

Related Conditions & MeSH terms

• Neoplasms by Site

Intervention

Biological:
• nivolumab
(Subcutaneous) Specified dose on specified days

Drug:
• rHuPH20
Specified dose on specified days Permeation enhancer

Biological:
• nivolumab
(IV) Specified Dose on Specified Days

Locations

Country	Name	City	State
Argentina	Local Institution - 0025	Caba
Argentina	Local Institution - 0035	Caba
Brazil	Local Institution - 0038	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0037	Sao Paulo
Chile	Local Institution - 0005	Santiago
France	Local Institution - 0022	Saint Herblain
France	Local Institution - 0021	Villejuif
Italy	Istituto Oncologico Veneto IOV	Padova
Italy	Local Institution - 0003	Rozzano
Mexico	Local Institution - 0048	Mexico City	Distrito Federal
Mexico	Local Institution - 0050	Mexico City	Distrito Federal
Mexico	Local Institution - 0046	Monterrey	Nuevo León
Mexico	Local Institution - 0047	Monterrey	Nuevo León
Mexico	Local Institution - 0049	Puebla
Mexico	Local Institution - 0045	Querétaro
Netherlands	Local Institution - 0026	Amsterdam
Netherlands	Local Institution - 0039	Maastricht
New Zealand	Local Institution - 0014	Dunedin
New Zealand	Local Institution - 0018	Newtown	Wellington
New Zealand	Local Institution - 0040	Rotorua	Bay Of Plenty
New Zealand	Local Institution - 0015	Tauranga
Poland	Local Institution - 0019	Warszawa	Mazowieckie
Spain	Local Institution - 0017	Madrid
Spain	Local Institution - 0016	Malaga
United Kingdom	Local Institution - 0033	Cardiff	Glamorgan
United Kingdom	Local Institution - 0031	Liverpool
United States	Winship Cancer Institute.	Atlanta	Georgia
United States	Local Institution - 0010	Austin	Texas
United States	Local Institution - 0009	Beaumont	Texas
United States	Local Institution - 0001	Charlotte	North Carolina
United States	Local Institution - 0007	Dallas	Texas
United States	Local Institution - 0020	Detroit	Michigan
United States	Local Institution - 0012	Eugene	Oregon
United States	Greenville Health System	Greenville	South Carolina
United States	Local Institution - 0024	Rockville	Maryland
United States	Local Institution - 0011	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  France,  Italy,  Mexico,  Netherlands,  New Zealand,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed serum concentration (Cmax)		Approximately 4 years
Primary	Time of maximum observed serum concentration (Tmax)		Approximately 4 years
Primary	Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]		Approximately 4 years
Primary	Observed serum concentration at the end of a dosing interval (Ctau)		Approximately 4 years
Primary	Trough observed serum nivolumab concentration (Ctrough)		Approximately 4 years
Secondary	Incidence of Adverse Events (AEs)		Approximately 4 years
Secondary	Incidence of AEs leading to deaths		Approximately 4 years
Secondary	Incidence of AEs leading to laboratory abnormalities		Approximately 4 years
Secondary	Incidence of AEs leading to discontinuation		Approximately 4 years
Secondary	Incidence of Treatment Related AEs (TRAEs)		Approximately 4 years
Secondary	Incidence of TRAEs leading to laboratory abnormalities		Approximately 4 years
Secondary	Incidence of TRAEs leading to discontinuation		Approximately 4 years
Secondary	Incidence of TRAEs leading to deaths		Approximately 4 years
Secondary	Incidence of Serious Adverse Events (SAEs)		Approximately 4 years
Secondary	Incidence of Treatment Related SAEs (TRSAEs)		Approximately 4 years
Secondary	Incidence of death		Approximately 4 years
Secondary	Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Approximately 4 years
Secondary	Incidence of clinically significant changes in clinical laboratory values: Chemistry tests		Approximately 4 years
Secondary	Incidence of clinically significant changes in clinical laboratory values: Serology tests		Approximately 4 years
Secondary	Number of Clinically Significant Changes in Lab Assessment of: Blood Serum		Approximately 4 years
Secondary	Number of Clinically Significant Changes in Lab Assessment of: Urine		Approximately 4 years
Secondary	Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction		Approximately 4 years
Secondary	Incidence of events within the hypersensitivity/infusion reaction select AE category		Approximately 4 years
Secondary	Incidence of anti-nivolumab antibodies		Approximately 4 years
Secondary	Incidence of neutralizing antibodies		Approximately 4 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls