A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | September 24, 2018 |
| End Date: | October 25, 2024 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
| Email: | ClinicalTrials@bms.com |
| Phone: | please email |
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)
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)
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
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)
- 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 could apply
We found this trial at
12
sites
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