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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03656718




Registration number
NCT03656718
Ethics application status
Date submitted
28/08/2018
Date registered
4/09/2018
Date last updated
8/12/2023

Titles & IDs
Public title
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Scientific title
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
Secondary ID [1] 0 0
2018-001585-42
Secondary ID [2] 0 0
CA209-8KX
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms by Site 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - nivolumab
Treatment: Drugs - rHuPH20
Other interventions - nivolumab

Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20 -

Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20 -

Experimental: Part B, Group 2: nivolumab (dose 1) -

Experimental: Part B, Group 4: nivolumab (dose 2) -

Experimental: Part C: nivolumab (dose 3) + rHuPH20 -

Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20 -

Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20 -


Other interventions: nivolumab
(Subcutaneous) Specified dose on specified days

Treatment: Drugs: rHuPH20
Specified dose on specified days Permeation enhancer

Other interventions: nivolumab
(IV) Specified Dose on Specified Days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [1] 0 0
Approximately 4 years
Primary outcome [2] 0 0
Time of maximum observed serum concentration (Tmax)
Timepoint [2] 0 0
Approximately 4 years
Primary outcome [3] 0 0
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Timepoint [3] 0 0
Approximately 4 years
Primary outcome [4] 0 0
Observed serum concentration at the end of a dosing interval (Ctau)
Timepoint [4] 0 0
Approximately 4 years
Primary outcome [5] 0 0
Trough observed serum nivolumab concentration (Ctrough)
Timepoint [5] 0 0
Approximately 4 years
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [2] 0 0
Incidence of AEs leading to deaths
Timepoint [2] 0 0
Approximately 4 years
Secondary outcome [3] 0 0
Incidence of AEs leading to laboratory abnormalities
Timepoint [3] 0 0
Approximately 4 years
Secondary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Approximately 4 years
Secondary outcome [5] 0 0
Incidence of Treatment Related AEs (TRAEs)
Timepoint [5] 0 0
Approximately 4 years
Secondary outcome [6] 0 0
Incidence of TRAEs leading to laboratory abnormalities
Timepoint [6] 0 0
Approximately 4 years
Secondary outcome [7] 0 0
Incidence of TRAEs leading to discontinuation
Timepoint [7] 0 0
Approximately 4 years
Secondary outcome [8] 0 0
Incidence of TRAEs leading to deaths
Timepoint [8] 0 0
Approximately 4 years
Secondary outcome [9] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Approximately 4 years
Secondary outcome [10] 0 0
Incidence of Treatment Related SAEs (TRSAEs)
Timepoint [10] 0 0
Approximately 4 years
Secondary outcome [11] 0 0
Incidence of death
Timepoint [11] 0 0
Approximately 4 years
Secondary outcome [12] 0 0
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Timepoint [12] 0 0
Approximately 4 years
Secondary outcome [13] 0 0
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Timepoint [13] 0 0
Approximately 4 years
Secondary outcome [14] 0 0
Incidence of clinically significant changes in clinical laboratory values: Serology tests
Timepoint [14] 0 0
Approximately 4 years
Secondary outcome [15] 0 0
Number of Clinically Significant Changes in Lab Assessment of: Blood Serum
Timepoint [15] 0 0
Approximately 4 years
Secondary outcome [16] 0 0
Number of Clinically Significant Changes in Lab Assessment of: Urine
Timepoint [16] 0 0
Approximately 4 years
Secondary outcome [17] 0 0
Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction
Timepoint [17] 0 0
Approximately 4 years
Secondary outcome [18] 0 0
Incidence of events within the hypersensitivity/infusion reaction select AE category
Timepoint [18] 0 0
Approximately 4 years
Secondary outcome [19] 0 0
Incidence of anti-nivolumab antibodies
Timepoint [19] 0 0
Approximately 4 years
Secondary outcome [20] 0 0
Incidence of neutralizing antibodies
Timepoint [20] 0 0
Approximately 4 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active brain metastases or leptomeningeal metastases

- Ocular melanoma

- Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/03/2025
Actual
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Caba
Country [9] 0 0
Brazil
State/province [9] 0 0
RIO Grande DO SUL
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
France
State/province [12] 0 0
Saint Herblain
Country [13] 0 0
France
State/province [13] 0 0
Villejuif
Country [14] 0 0
Italy
State/province [14] 0 0
Padova
Country [15] 0 0
Italy
State/province [15] 0 0
Rozzano
Country [16] 0 0
Mexico
State/province [16] 0 0
Distrito Federal
Country [17] 0 0
Mexico
State/province [17] 0 0
Nuevo León
Country [18] 0 0
Mexico
State/province [18] 0 0
Puebla
Country [19] 0 0
Mexico
State/province [19] 0 0
Querétaro
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Maastricht
Country [22] 0 0
New Zealand
State/province [22] 0 0
Bay Of Plenty
Country [23] 0 0
New Zealand
State/province [23] 0 0
Wellington
Country [24] 0 0
New Zealand
State/province [24] 0 0
Dunedin
Country [25] 0 0
New Zealand
State/province [25] 0 0
Tauranga
Country [26] 0 0
Poland
State/province [26] 0 0
Mazowieckie
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Malaga
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Glamorgan
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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)

- 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03656718
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries