Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03656718
Ethics application status
Date submitted
28/08/2018
Date registered
4/09/2018
Date last updated
25/03/2025

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
Treatment: Other - nivolumab
Treatment: Drugs - rHuPH20
Treatment: Other - 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 -


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

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

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

Outcomes
Primary outcome [1] 0 0
Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E
Timepoint [1] 0 0
From first dose until approximately 21 days post first dose.
Primary outcome [2] 0 0
Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E
Timepoint [2] 0 0
From first dose until approximately 21 days post first dose.
Primary outcome [3] 0 0
Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E
Timepoint [3] 0 0
From first dose until approximately 21 days post first dose.
Primary outcome [4] 0 0
Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E
Timepoint [4] 0 0
At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)
Primary outcome [5] 0 0
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C
Timepoint [5] 0 0
On Day 1 of Cycles 2, 3, 5, 9, 13, and 19 of Part C (Day 1 of Part C: up to 14 months from Baseline; each cycle was 28 days)
Secondary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
From first dose until 100 days post last dose (up to approximately 28 months).
Secondary outcome [2] 0 0
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)
Timepoint [2] 0 0
From first dose until 100 days post last dose (up to approximately 28 months).
Secondary outcome [3] 0 0
Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [3] 0 0
From first dose until 100 days post last dose (up to approximately 28 months).
Secondary outcome [4] 0 0
Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)
Timepoint [4] 0 0
From first dose until 100 days post last dose (up to approximately 28 months).
Secondary outcome [5] 0 0
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation
Timepoint [5] 0 0
From first dose until 100 days post last dose (up to approximately 28 months).
Secondary outcome [6] 0 0
Number of Participants Who Died
Timepoint [6] 0 0
From randomization until data cutoff (up to approximately 46 months).
Secondary outcome [7] 0 0
Number of Participants With Select Laboratory Changes From Baseline
Timepoint [7] 0 0
From first dose until 30 days post last dose (up to approximately 25 months).
Secondary outcome [8] 0 0
Number of Participants Experiencing Any Select Adverse Events Within the Hypersensitivity/Infusion Reaction Category and Broad Standardized MedDRA Query (SMQ) of Anaphylactic Reaction Occurring Within 2 Days of Study Drug Administration
Timepoint [8] 0 0
From first dose until 2 days post last dose (up to approximately 24 months and 2 days).
Secondary outcome [9] 0 0
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies
Timepoint [9] 0 0
At baseline and up to 100 days post last dose (up to approximately 28 months).

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/09/2024
Sample size
Target
Accrual to date
Final
139
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
MI
Country [15] 0 0
Italy
State/province [15] 0 0
Padova
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
Noord-Holland
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03656718