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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
25/03/2025
Titles & IDs
Public title
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
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Scientific title
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
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Secondary ID [1]
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2018-001585-42
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Secondary ID [2]
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CA209-8KX
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms by Site
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Condition category
Condition code
Cancer
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Any cancer
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E
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Assessment method [1]
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Cmax is the maximum observed serum nivolumab concentration. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
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Timepoint [1]
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From first dose until approximately 21 days post first dose.
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Primary outcome [2]
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Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E
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Assessment method [2]
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Tmax is the time taken to reach the maximum observed serum nivolumab concentration (Cmax). Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
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Timepoint [2]
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From first dose until approximately 21 days post first dose.
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Primary outcome [3]
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Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E
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Assessment method [3]
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AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
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Timepoint [3]
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From first dose until approximately 21 days post first dose.
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Primary outcome [4]
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Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E
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Assessment method [4]
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Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.
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Timepoint [4]
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At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)
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Primary outcome [5]
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Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C
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Assessment method [5]
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Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.
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Timepoint [5]
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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)
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Secondary outcome [1]
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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [1]
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From first dose until 100 days post last dose (up to approximately 28 months).
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Secondary outcome [2]
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Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)
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Assessment method [2]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.
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Timepoint [2]
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From first dose until 100 days post last dose (up to approximately 28 months).
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Secondary outcome [3]
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Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [3]
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A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization.
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Timepoint [3]
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From first dose until 100 days post last dose (up to approximately 28 months).
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Secondary outcome [4]
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Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)
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Assessment method [4]
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A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization. TRSAEs are SAEs where a reasonable causal relationship exists between study treatment administration and the SAE.
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Timepoint [4]
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From first dose until 100 days post last dose (up to approximately 28 months).
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Secondary outcome [5]
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Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation
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Assessment method [5]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.
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Timepoint [5]
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From first dose until 100 days post last dose (up to approximately 28 months).
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Secondary outcome [6]
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Number of Participants Who Died
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Assessment method [6]
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Number of participants who died due to any cause.
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Timepoint [6]
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From randomization until data cutoff (up to approximately 46 months).
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Secondary outcome [7]
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Number of Participants With Select Laboratory Changes From Baseline
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Assessment method [7]
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Laboratory parameters including hematology, chemistry, liver function, and renal function summarized using worst grade NCI CTCAE v.5 criteria. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.
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Timepoint [7]
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From first dose until 30 days post last dose (up to approximately 25 months).
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Secondary outcome [8]
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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
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Assessment method [8]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [8]
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From first dose until 2 days post last dose (up to approximately 24 months and 2 days).
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Secondary outcome [9]
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Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies
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Assessment method [9]
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Anti-drug antibody (ADA) Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment; Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline. Baseline ADA Positive: A participant with a baseline ADA-positive sample. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.
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Timepoint [9]
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At baseline and up to 100 days post last dose (up to approximately 28 months).
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/09/2024
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Sample size
Target
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Accrual to date
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Final
139
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
0
0
United States of America
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State/province [3]
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Michigan
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Country [4]
0
0
United States of America
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State/province [4]
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0
North Carolina
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Country [5]
0
0
United States of America
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State/province [5]
0
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Oregon
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Country [6]
0
0
United States of America
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State/province [6]
0
0
South Carolina
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Country [7]
0
0
United States of America
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State/province [7]
0
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Texas
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Country [8]
0
0
Argentina
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State/province [8]
0
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Caba
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Country [9]
0
0
Brazil
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State/province [9]
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RIO Grande DO SUL
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Country [10]
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Brazil
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State/province [10]
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Sao Paulo
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Country [11]
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Chile
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State/province [11]
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Santiago
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Country [12]
0
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France
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State/province [12]
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Saint Herblain
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Country [13]
0
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France
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State/province [13]
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Villejuif
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Country [14]
0
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Italy
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State/province [14]
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MI
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Country [15]
0
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Italy
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State/province [15]
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Padova
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Country [16]
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Mexico
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State/province [16]
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Distrito Federal
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Country [17]
0
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Mexico
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State/province [17]
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Nuevo León
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Country [18]
0
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Mexico
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State/province [18]
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Puebla
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Country [19]
0
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Mexico
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State/province [19]
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Querétaro
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Country [20]
0
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Netherlands
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State/province [20]
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Noord-Holland
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Country [21]
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Netherlands
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State/province [21]
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Maastricht
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Country [22]
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New Zealand
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State/province [22]
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Bay Of Plenty
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Country [23]
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New Zealand
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State/province [23]
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Wellington
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Country [24]
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New Zealand
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State/province [24]
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Dunedin
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Country [25]
0
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New Zealand
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State/province [25]
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Tauranga
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Country [26]
0
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Poland
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State/province [26]
0
0
Mazowieckie
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Country [27]
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Spain
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State/province [27]
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Madrid
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Country [28]
0
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Spain
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State/province [28]
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Malaga
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Country [29]
0
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United Kingdom
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State/province [29]
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Glamorgan
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Country [30]
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United Kingdom
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State/province [30]
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Liverpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT03656718
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT03656718/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT03656718/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03656718
Download to PDF