A Phase 1/2, Multicenter Study Of Nktr-262/Nktr-214 With Or Without Nivolumab In Patients With Multiple Solid Tumors
Posted Date: Jun 12, 2019
- Investigator: Shuchi Gulati
- Specialties:
- Type of Study: Drug
This is an investigational study of a drug called NKTR-262 that will be given together with a drug called NKTR-214 and also possibly another drug called Opdivo® (nivolumab). Patients with multiple solid tumors can be eligible for this study- melanoma, Merkel cell carcinoma, renal cell carcinoma, bladder cancer, triple negative breast cancer , ovarian cancer, sarcoma, or colorectal cancer that has locally advanced (returned) or has spread (metastatic solid tumor malignancies). NKTR-262, also referred to as “Study Drug A”, is an investigational drug. In animal studies, NKTR-262 has been shown to activate immune cells to help them attack cancer cells. NKTR-262 is based on the active compound resiquimod, which has been tested in humans. NKTR-262 has not been used in humans before and has not been approved to treat cancer. NKTR-214, also referred to as “Study Drug B”, is a modified (changed in the laboratory) form of interleukin-2 (or IL-2) that is normally made by your immune system. IL-2 makes other cells in your immune system attack cancer cells. IL-2 has been used to treat certain cancers for many years. NKTR-214 is currently being tested in clinical trials, and has not been approved to treat cancer. Opdivo® (also called “Study Drug C”) is approved for treatment of unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC), classical Hodgkin’s lymphoma (cHL), squamous cell head and neck cancer (SCCHN), and renal cell carcinoma (RCC), urothelial carcinoma, certain types of metastatic colorectal cancer, hepatocellular carcinoma. Opdivo® is also called anti-PD-1 and works to enhance your body’s immune system to fight your specific cancer type. Opdivo® is approved for use in multiple countries including the United States (2014), Japan (2014), and the European Union (2015). The purpose of this study is to test the safety, tolerability, and effectiveness (how well these drugs work together) of the Study Drug A and Study Drug B given together (“Doublet therapy”) or of the Study Drug A and Study Drug B given with Opdivo® (“Triplet therapy”). We want to find out what effects, good or bad, the Doublet therapy or Triplet therapy has on you and your cancer.
Criteria:
Null
Keywords:
Several Solid Tumors
For More Information:
Shuchi Gulati
5135580147
gulatisi@ucmail.uc.edu