A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
NCT ID: NCT03656718
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
139 participants
INTERVENTIONAL
2018-10-29
2024-09-12
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A, Group 1: nivolumab (dose 1) + rHuPH20
nivolumab
(Subcutaneous) Specified dose on specified days
rHuPH20
Specified dose on specified days Permeation enhancer
nivolumab
(IV) Specified Dose on Specified Days
Part B, Group 3: nivolumab (dose 2) + rHuPH20
nivolumab
(Subcutaneous) Specified dose on specified days
rHuPH20
Specified dose on specified days Permeation enhancer
nivolumab
(IV) Specified Dose on Specified Days
Part B, Group 2: nivolumab (dose 1)
nivolumab
(Subcutaneous) Specified dose on specified days
nivolumab
(IV) Specified Dose on Specified Days
Part B, Group 4: nivolumab (dose 2)
nivolumab
(Subcutaneous) Specified dose on specified days
nivolumab
(IV) Specified Dose on Specified Days
Part C: nivolumab (dose 3) + rHuPH20
nivolumab
(Subcutaneous) Specified dose on specified days
rHuPH20
Specified dose on specified days Permeation enhancer
Part D, Group 5: nivolumab (dose 3) + rHuPH20
nivolumab
(Subcutaneous) Specified dose on specified days
rHuPH20
Specified dose on specified days Permeation enhancer
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
nivolumab
(Subcutaneous) Specified dose on specified days
rHuPH20
Specified dose on specified days Permeation enhancer
Interventions
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nivolumab
(Subcutaneous) Specified dose on specified days
rHuPH20
Specified dose on specified days Permeation enhancer
nivolumab
(IV) Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* Ocular melanoma
* Active, known, or suspected autoimmune disease
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Winship Cancer Institute.
Atlanta, Georgia, United States
Local Institution - 0024
Rockville, Maryland, United States
Local Institution - 0020
Detroit, Michigan, United States
Local Institution - 0001
Charlotte, North Carolina, United States
Local Institution - 0012
Eugene, Oregon, United States
Greenville Health System
Greenville, South Carolina, United States
Local Institution - 0010
Austin, Texas, United States
Local Institution - 0009
Beaumont, Texas, United States
Local Institution - 0007
Dallas, Texas, United States
Local Institution - 0011
Tyler, Texas, United States
Local Institution - 0035
CABA, , Argentina
Local Institution - 0025
CABA, , Argentina
Local Institution - 0038
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0037
São Paulo, , Brazil
Local Institution - 0005
Santiago, , Chile
Local Institution - 0022
Saint-Herblain, , France
Local Institution - 0021
Villejuif, , France
Local Institution - 0003
Rozzano, MI, Italy
Local Institution - 0004
Padua, , Italy
Local Institution - 0050
Mexico City, Mexico City, Mexico
Local Institution - 0048
Mexico City, Mexico City, Mexico
Local Institution - 0046
Monterrey, Nuevo León, Mexico
Local Institution - 0047
Monterrey, Nuevo León, Mexico
Local Institution - 0049
Puebla City, , Mexico
Local Institution - 0045
Querétaro, , Mexico
Local Institution - 0026
Amsterdam, North Holland, Netherlands
Local Institution - 0039
Maastricht, , Netherlands
Local Institution - 0040
Rotorua, Bay of Plenty, New Zealand
Local Institution - 0018
Newtown, Wellington Region, New Zealand
Local Institution - 0014
Dunedin, , New Zealand
Local Institution - 0015
Tauranga, , New Zealand
Local Institution - 0019
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0017
Madrid, , Spain
Local Institution - 0016
Málaga, , Spain
Local Institution - 0033
Cardiff, Glamorgan, United Kingdom
Local Institution - 0031
Liverpool, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-001585-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-8KX
Identifier Type: -
Identifier Source: org_study_id