Phase 2
Completed N=139
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Neoplasms by Site
Source: ClinicalTrials.gov NCT03656718 ↗
Enrolled (actual)
139
Serious AEs
55.1%
Results posted
Feb 2025
Primary outcomePrimary: Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E — 54.8; 56.6; 81.4; 63.9 ug/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E |
54.8; 56.6; 81.4; 63.9; 106.0; 57.8 | — |
| PRIMARY Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E |
167; 167; 141; 168; 130; 130 | — |
| PRIMARY Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E |
24908; 27909; 40264; 32702; 53561; 15857 | — |
| PRIMARY Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E |
22.2; 26.9; 39.2; 34.8; 54.4; 43.6 | — |
| PRIMARY Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C |
115; 106; 124; 85.7; 119; 118 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
22; 18; 10; 17; 27; 36 | — |
| SECONDARY Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) |
14; 10; 8; 11; 16; 27 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAEs) |
12; 10; 4; 11; 11; 19 | — |
| SECONDARY Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs) |
1; 1; 0; 2; 0; 3 | — |
| SECONDARY Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation |
2; 1; 1; 2; 0; 4 | — |
| SECONDARY Number of Participants Who Died |
18; 14; 8; 14; 17; 25 | — |
| SECONDARY Number of Participants With Select Laboratory Changes From Baseline |
13; 7; 3; 8; 15; 12 | — |
| SECONDARY 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 |
1; 1; 0; 0; 4; 3 | — |
| SECONDARY Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies |
7; 5; 3; 0; 7; 5 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- 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
Exclusion Criteria
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03656718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.