CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 139 enrolled
Drug / intervention
nivolumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03656718
NCT03656718Phase 2Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Sep 4, 2018·Updated Nov 12, 2025

In Brief

A Phase 2 clinical trial evaluating nivolumab and rHuPH20 for Neoplasms by Site. Completed, enrolled 139 participants across 36 sites in 12 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms by Site
CountriesArgentina, Brazil, Chile, France, Italy, Mexico, Netherlands, New Zealand, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 4, 2018
Enrollment StartOct 29, 2018
Primary CompletionSep 7, 2022
Study CompletionSep 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.8 years ago

Interventions

nivolumabbiological

(Subcutaneous) Specified dose on specified days

rHuPH20drug

Specified dose on specified days Permeation enhancer

nivolumabbiological

(IV) Specified Dose on Specified Days