What the trial was testing
The BTCRC-GU14-003 enrolled 61 patients with kidney cancer. The study was sponsored by Arkadiusz Z. Dudek, MD and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
61% of patients had their tumors shrink with the combination treatment.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020 · NCT02348008
These findings — that had their tumors shrink with the combination treatment — were published in the Journal of clinical oncology : official journal of the American Society of Clinical Oncology and represent the headline result of the study.
Researchers tracked outcomes across 61 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with kidney cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial testing study and this exact combination is not FDA-approved for first-line kidney cancer. However, pembrolizumab is FDA-approved for certain kidney cancers, and similar checkpoint inhibitor combinations are now standard care. Ask your oncologist about approved checkpoint inhibitor options for metastatic kidney cancer.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open kidney cancer trials
Urine Omics Predicting IO Therapy Responses in mRCC Patients
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.
Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
Background: \- Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system. Objectives: \- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers. Eligibility: * Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age. * Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults. Design: * Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study. * No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.