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

Status
Active
Cancer Type
Colon/Rectal Cancer
Liver Cancer / Hepatoblastoma
Melanoma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03656718
Protocol IDs
CA209-8KX (primary)
NCI-2018-02324
2018-001585-42
Study Sponsor
Bristol-Myers Squibb

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).

Eligibility

  1. Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
  2. Metastatic squamous or non-squamous NSCLC
  3. RCC, advanced or metastatic
  4. Melanoma
  5. HCC
  6. CRC, metastatic (MSI-H or dMMR)
  7. In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
  8. In Part E, Metastatic urothelial carcinoma
  9. Measurable disease as per RECIST version 1.1 criteria
  10. ECOG performance status of 0 or 1

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.