A Phase 2 trial to evaluate the safety and efficacy of NKT2152 in Combination with Palbociclib (Doublet) and with Palbociclib and Sasanlimab (Triplet) in subjects with advanced or Metastatic Clear Cell Renal Cell Carcinoma.

UVA Tracking #
HSR220311
Principal Investigator
Robert Dreicer
Contact
Contact Phone
Official Trial Title
A Phase 2 Trial to Evaluate the Safety and Efficacy of NKT2152 in Combination with Palbociclib (Doublet) and with Palbociclib and Sasanlimab (Triplet) in Patients with Advanced or Metastatic Renal Clear Cell Carcinoma
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with advanced or Metastatic Clear Cell Renal Cell Carcinoma to participate in a research study. This study will evaluate whether an investigational drug not yet approved by the FDA, called NKT2152, will help in the treatment of renal cell carcinoma when combined with one or two other drugs, palbociclib and sasanlimab. The study will also evaluate how safe NKT2152 is to use in people when combined with these other investigational drugs, palbociclib and sasanlimab. You may receive NKT2152 in combination with palbociclib, or NKT2152 in combination with both palbociclib and sasanlimab. The purpose of the study is to evaluate how safe this combination of drugs is and find the best test the safety and dose levels of these drugs, as well as evaluate whether the study drug has an effect on decreasing the size of tumors.

The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening visit, a treatment period where you have 2 visits per 28 day cycles (3-4 visits in cycle 1), up to 3 follow-up visits after treatment, and a follow-up period via phone calls to keep track of how you are doing. How long you will be on the study depends on your ability to safely tolerate the study treatment, your response to study treatment, and your and/or your study doctor’s decision for you to continue study treatment.

The investigational drugs NKT2152, palbociclib, and sasanlimab, as well as all study-related procedures including doctor's visits and laboratory tests, will be provided at no cost to you.

Reimbursement - $55 per visit
Hotel Reimbursement – up to $175

More information about this study can be found at https://clinicaltrials.gov

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation