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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
22/07/2024

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 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
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
29/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/09/2024
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
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
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
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03656718