Neoplasms by SitePhase 1/2NCT03656718

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

A Phase 1/2 study testing nivolumab and rHuPH20 in people with Neoplasms by Site, run by Bristol-Myers Squibb at 36 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms by Site
What is being tested?: nivolumab and rHuPH20
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 36 sitesin 12 countries
Study dates: 29 Oct 2018to 12 Sep 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
Metastatic squamous or non-squamous NSCLC
RCC, advanced or metastatic
Melanoma
HCC
CRC, metastatic (MSI-H or dMMR)

Show all 10Show fewer

In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
In Part E, Metastatic urothelial carcinoma
Measurable disease as per RECIST version 1.1 criteria
ECOG performance status of 0 or 1

Who cannot join

Active brain metastases or leptomeningeal metastases
Ocular melanoma
Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

36 sites in 12 countries.

Country

City, postcode or hospital

36 sites in 12 countries

United States10 sites

Winship Cancer Institute.
Atlanta, Georgia, 30322
Local Institution - 0010
Austin, Texas, 78705
Local Institution - 0009
Beaumont, Texas, 77702-1449
Local Institution - 0001
Charlotte, North Carolina, 28204
Local Institution - 0007
Dallas, Texas, 75246
Local Institution - 0020
Detroit, Michigan, 48201-2014
Local Institution - 0012
Eugene, Oregon, 97401
Greenville Health System
Greenville, South Carolina, 29605
Local Institution - 0024
Rockville, Maryland, 20850
Local Institution - 0011
Tyler, Texas, 75702

Other trials in United States

Mexico6 sites

Local Institution - 0050
Mexico City, Mexico City, 03100
Local Institution - 0048
Mexico City, Mexico City, 14080
Local Institution - 0046
Monterrey, Nuevo León, 64710
Local Institution - 0047
Monterrey, Nuevo León, 66460
Local Institution - 0049
Puebla City, 72424
Local Institution - 0045
Querétaro, 76000

Other trials in Mexico

New Zealand4 sites

Local Institution - 0014
Dunedin, 9012
Local Institution - 0018
Newtown, Wellington Region, 6021
Local Institution - 0040
Rotorua, Bay of Plenty, 3046
Local Institution - 0015
Tauranga, 3112

Other trials in New Zealand

Argentina2 sites

Local Institution - 0035
CABA, 1199
Local Institution - 0025
CABA, 1426

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Brazil2 sites

Local Institution - 0038
Porto Alegre, Rio Grande do Sul, 90610000
Local Institution - 0037
São Paulo, 05651-901

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France2 sites

Local Institution - 0022
Saint-Herblain, 44805
Local Institution - 0021
Villejuif, 94805

Other trials in France

Italy2 sites

Local Institution - 0004
Padova, 35128
Local Institution - 0003
Rozzano, MI, 20089

Other trials in Italy

Netherlands2 sites

Local Institution - 0026
Amsterdam, North Holland, 1066 CX
Local Institution - 0039
Maastricht, 6229 HX

Other trials in Netherlands

Spain2 sites

Local Institution - 0017
Madrid, 28007
Local Institution - 0016
Málaga, 29010

Other trials in Spain

United Kingdom2 sites

Local Institution - 0033
Cardiff, Glamorgan, CF14 2TL
Local Institution - 0031
Liverpool, L7 8YA

Other trials in United Kingdom

Chile1 site

Local Institution - 0005
Santiago, 0

Other trials in Chile

Poland1 site

Local Institution - 0019
Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

About this study

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

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).

Conditions: Neoplasms by Site
Being tested: nivolumab, rHuPH20
Keywords: Subcutaneous, Nivolumab, rHuPH20
Medical subject headings: Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nivolumabBiological
Also called Opdivo, BMS-986298
(Subcutaneous) Specified dose on specified days
rHuPH20Drug
Also called ENHANZE™ DP
Specified dose on specified days Permeation enhancer
nivolumabBiological
Also called BMS-936558
(IV) Specified Dose on Specified Days

Study groups in NCT03656718
Study group	Role	What they receive
Part A, Group 1: nivolumab (dose 1) + rHuPH20	Experimental	Not described Receives: Biological: nivolumab; Drug: rHuPH20
Part B, Group 3: nivolumab (dose 2) + rHuPH20	Experimental	Not described Receives: Biological: nivolumab; Drug: rHuPH20
Part B, Group 2: nivolumab (dose 1)	Experimental	Not described Receives: Biological: nivolumab
Part B, Group 4: nivolumab (dose 2)	Experimental	Not described Receives: Biological: nivolumab
Part C: nivolumab (dose 3) + rHuPH20	Experimental	Not described Receives: Biological: nivolumab; Drug: rHuPH20
Part D, Group 5: nivolumab (dose 3) + rHuPH20	Experimental	Not described Receives: Biological: nivolumab; Drug: rHuPH20
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20	Experimental	Not described Receives: Biological: nivolumab; Drug: rHuPH20

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E
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.
Measured: From first dose until approximately 21 days post first dose.
Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E
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.
Measured: From first dose until approximately 21 days post first dose.
Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E
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.
Measured: From first dose until approximately 21 days post first dose.
Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E
Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.
Measured: At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C
Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.
Measured: 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 outcomes (9)

Number of Participants Experiencing Adverse Events (AEs)
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.
Measured: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)
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.
Measured: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Serious Adverse Events (SAEs)
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.
Measured: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)
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.
Measured: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation
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.
Measured: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Who Died
Number of participants who died due to any cause.
Measured: From randomization until data cutoff (up to approximately 70 months).
Number of Participants With Select Laboratory Changes From Baseline
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.
Measured: From first dose until 30 days post last dose (up to approximately 67 months and 20 days).
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
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.
Measured: From first dose until 2 days post last dose (up to approximately 66 months and 22 days).
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies
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.
Measured: At baseline and up to 100 days post last dose (up to approximately 70 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201812 Sep 2024

First posted4 Sep 2018
Study start29 Oct 2018
Primary completion7 Sep 2022
Study completion12 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neoplasms by SiteStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03656718
Sponsor's protocol ID: CA209-8KX
Other IDs: 2018-001585-42, 2018
Status last verified: Oct 2025
First submitted: 28 Aug 2018
Last updated: 12 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Lonardi S, Lugowska I, O'Donnell A, Jackson C, Latten-Jansen LM, North R, Bahleda R, Garrido M, Santoro A, Chacon MR, Li L, Joseph D, Vezina HE, Aras U, Bennett B, Perumal D, Gurm B, Ng WT, Harvey RD, Trigo J, Calvo A. Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study. J Immunother Cancer. 2025 Oct 5;13(10):e011918. doi: 10.1136/jitc-2025-011918.
PubMed 41052885

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
ClinicalTrials.gov ID: NCT03656718
Acronym / sponsor ID: CA209-8KX
Conditions: Neoplasms by Site
Keywords: Subcutaneous, Nivolumab, rHuPH20
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 29 Oct 2018 (actual)
Primary completion: 7 Sep 2022 (actual)
Study completion: 12 Sep 2024 (actual)
First posted: 4 Sep 2018 (actual)
Results: Posted 20 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Part A, Group 1: nivolumab (dose 1) + rHuPH20	Experimental	Biological: nivolumab, Drug: rHuPH20
Part B, Group 3: nivolumab (dose 2) + rHuPH20	Experimental	Biological: nivolumab, Drug: rHuPH20
Part B, Group 2: nivolumab (dose 1)	Experimental	Biological: nivolumab
Part B, Group 4: nivolumab (dose 2)	Experimental	Biological: nivolumab
Part C: nivolumab (dose 3) + rHuPH20	Experimental	Biological: nivolumab, Drug: rHuPH20
Part D, Group 5: nivolumab (dose 3) + rHuPH20	Experimental	Biological: nivolumab, Drug: rHuPH20
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20	Experimental	Biological: nivolumab, Drug: rHuPH20

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
Measurable disease as per RECIST version 1.1 criteria
ECOG performance status of 0 or 1

Key exclusion criteria (4 listed)

Active brain metastases or leptomeningeal metastases
Ocular melanoma
Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nivolumabAlso: Opdivo, BMS-986298(Subcutaneous) Specified dose on specified days	Biological	Part A, Group 1: nivolumab (dose 1) + rHuPH20, Part B, Group 2: nivolumab (dose 1), Part B, Group 3: nivolumab (dose 2) + rHuPH20, Part B, Group 4: nivolumab (dose 2), Part C: nivolumab (dose 3) + rHuPH20, Part D, Group 5: nivolumab (dose 3) + rHuPH20, Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
rHuPH20Also: ENHANZE™ DPSpecified dose on specified days Permeation enhancer	Drug	Part A, Group 1: nivolumab (dose 1) + rHuPH20, Part B, Group 3: nivolumab (dose 2) + rHuPH20, Part C: nivolumab (dose 3) + rHuPH20, Part D, Group 5: nivolumab (dose 3) + rHuPH20, Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
nivolumabAlso: BMS-936558(IV) Specified Dose on Specified Days	Biological	Part A, Group 1: nivolumab (dose 1) + rHuPH20, Part B, Group 2: nivolumab (dose 1), Part B, Group 3: nivolumab (dose 2) + rHuPH20, Part B, Group 4: nivolumab (dose 2)

Primary outcome

Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E
Time frame: From first dose until approximately 21 days post first dose.
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.
Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E
Time frame: From first dose until approximately 21 days post first dose.
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.
Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E
Time frame: From first dose until approximately 21 days post first dose.
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.
Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E
Time frame: At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)
Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C
Time frame: 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)
Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.

9 secondary outcomes

Number of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)
Time frame: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)
Time frame: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation
Time frame: From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Who Died
Time frame: From randomization until data cutoff (up to approximately 70 months).
Number of Participants With Select Laboratory Changes From Baseline
Time frame: From first dose until 30 days post last dose (up to approximately 67 months and 20 days).
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
Time frame: From first dose until 2 days post last dose (up to approximately 66 months and 22 days).
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies
Time frame: At baseline and up to 100 days post last dose (up to approximately 70 months).

Results and safety

Results posted to the registry on 20 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg	22	22
Part B - Group 2: Nivolumab SC 720mg	18	18
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg	10	10
Part B - Group 4: Nivolumab SC 960mg	17	17
Part C - Nivolumab SC + rHuPH20 1200 mg Q4W	0	0
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W	36	36
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W	36	36

Primary outcome: Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E

Time frame: From first dose until approximately 21 days post first dose.. Geometric mean (Geometric Coefficient of Variation). Unit: ug/mL

Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n = 22	Part B - Group 2: Nivolumab SC 720mg n = 18	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n = 10	Part B - Group 4: Nivolumab SC 960mg n = 17	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n = 34	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n = 36
Value	54.8 (51.0)	56.6 (34.0)	81.4 (41.0)	63.9 (30.0)	106.0 (46.0)	57.8 (31.0)

Population analysed: All treated participants with available Cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.

Primary outcome: Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E

Time frame: From first dose until approximately 21 days post first dose.. Median (Full Range). Unit: hours

Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n = 22	Part B - Group 2: Nivolumab SC 720mg n = 18	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n = 10	Part B - Group 4: Nivolumab SC 960mg n = 17	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n = 34	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n = 36
Value	167 (47.0 to 357.0)	167 (50.1 to 339.0)	141 (47.2 to 333.0)	168 (139.0 to 355.0)	130 (44.5 to 317.0)	130 (45.2 to 337.0)

Population analysed: All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.

Primary outcome: Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E

Time frame: From first dose until approximately 21 days post first dose.. Geometric mean (Geometric Coefficient of Variation). Unit: h*ug/mL

Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n = 20	Part B - Group 2: Nivolumab SC 720mg n = 16	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n = 10	Part B - Group 4: Nivolumab SC 960mg n = 13	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n = 33	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n = 35
Value	24908 (53)	27909 (36)	40264 (45)	32702 (31)	53561 (40)	15857 (30)

Population analysed: All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.

Primary outcome: Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E

Time frame: At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E). Geometric mean (Geometric Coefficient of Variation). Unit: ug/mL

Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n = 20	Part B - Group 2: Nivolumab SC 720mg n = 16	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n = 10	Part B - Group 4: Nivolumab SC 960mg n = 13	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n = 33	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n = 35
Value	22.2 (86)	26.9 (65)	39.2 (67)	34.8 (41)	54.4 (49)	43.6 (36)

Population analysed: All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be collected only in Parts A, B, D, and E.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg	12 of 22 (54.5%)	22 of 22 (100%)	18 of 22
PART A - GRP 1 CROSSOVER to PART C	4 of 9 (44.4%)	9 of 9 (100%)	6 of 9
Part B - Group 2: Nivolumab SC 720mg	10 of 18 (55.6%)	18 of 18 (100%)	14 of 18
PART B - GRP 2 CROSSOVER to PART C	1 of 6 (16.7%)	6 of 6 (100%)	2 of 6
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg	4 of 10 (40%)	10 of 10 (100%)	8 of 10
PART B - GRP 3 CROSSOVER to PART C	2 of 5 (40%)	5 of 5 (100%)	4 of 5
Part B - Group 4: Nivolumab SC 960mg	11 of 17 (64.7%)	17 of 17 (100%)	14 of 17
PART B - GRP 4 CROSSOVER to PART C	4 of 8 (50%)	8 of 8 (100%)	5 of 8
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W	19 of 36 (52.8%)	34 of 36 (94.4%)	25 of 36
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W	25 of 36 (69.4%)	35 of 36 (97.2%)	30 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41052885Lonardi S, Lugowska I, O'Donnell A, Jackson C, Latten-Jansen LM, North R, Bahleda R, Garrido M, Santoro A, Chacon MR, Li L, Joseph D, Vezina HE, Aras U, Bennett B, Perumal D, Gurm B, Ng WT, Harvey RD, Trigo J, Calvo A. Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study. J Immunother Cancer. 2025 Oct 5;13(10):e011918. doi: 10.1136/jitc-2025-011918.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

36 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nivolumab and rHuPH20 in people with Neoplasms by Site, run by Bristol-Myers Squibb at 36 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Mexico, New Zealand, Argentina, Brazil and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E (time frame: From first dose until approximately 21 days post first dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.