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- In this conversation, Pedro Barata and Andrea Apolo highlight an exploratory analysis of the CheckMate 9ER trial in patients with previously untreated advanced renal cell carcinoma (aRCC), looking at the association between depth of response and clinical outcomes with extended follow-up (minimum 25.4 months; median 32.9 months). In January 2021, the Food and Drug Administration (FDA) approved the...
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- Thomas Powles discusses the results of the CALYPSO trial with Pedro Barata. Dr. Powles provides an overview of the trial design of this international, multicentre, open-label phase Ib/IIa study of durvalumab alone, savolitinib alone, and durvalumab in combination with savolitinib or tremelimumab in patients with metastatic renal cell cancer. He then discusses the trial results, plus his thoughts o...
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- Deepak Kilari joins Pedro Barata in a discussion on the ORACLE study, which investigates the efficacy of combination systemic therapies in patients with advanced non-clear cell renal cell carcinoma. Dr. Kilari gives an overview of the trial design and shares his hopes and goals for the future of this trial as it continues to expand to more institutions and provide a larger, more robust data set. B...
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- Pedro Barata is joined by Maxime Meylan to discuss a key ancillary analysis of the phase II BIONIKK trial aimed at understanding immune markers predictive of the efficacy of immune checkpoint inhibition as first-line therapy in metastatic clear cell renal cell carcinoma (mccRCC). This analysis demonstrates that the number of tertiary lymphoid structures and ki67+PD1+ density likely predict the eff...
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- Sarmad Sadeghi and Pedro Barata discuss the results of a randomized Phase II that explored OX40in combination with axitinib in patients with renal cell carcinoma. Patients in the trial had progressive disease after receiving immunotherapy with the usual PD-1/PD-L1 antibodies. The primary endpoint was progression-free survival. Dr. Sadeghi describes the rationale for the trial design, why the trial...
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- Andrea Apolo, Pavlos Msaouel, and Petros Grivas discuss findings and recommendations shared during an ASCO presentation on clinical trial endpoints in the adjuvant setting for RCC kidney cancer and urothelial cancer. The conversation touches on trial design and efficacy, as well as concerns about treatment burden, toxicity, cost, and survival benefit. Patient advocacy and patient-specific issues r...
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- Alicia Morgans is joined by Toni Choueiri in a discussion on integrating therapies earlier in the treatment landscape for renal cell carcinoma (RCC), specifically highlighting the HIF-2α inhibitor and the phase 2 study of belzutifan plus cabozantinib as first-line treatment of advanced RCC, the LITESPARK-003 study. This was an oral presentation at the 2022 ESMO meeting. Belzutifan, a first-in-clas...
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- Alicia Morgans is joined by Toni Choueiri in a discussion on the COSMIC-313 examining the role of triplet therapy with cabozantinib, nivolumab and ipilimumab as first-line treatment in patients with advanced renal cell carcinoma (RCC). The COSMIC-313 trial made strides at the 2022 ESMO meeting being a presidential symposium reporting the first phase 3 clinical trial in advanced RCC to use a contem...
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- Ricardo Fernandes joins Pedro Barata in a discussion on PERFORM, an ongoing phase I study evaluating the safety of fecal microbiota transplantation (FMT) and immunotherapy combination in first-line (1L) metastatic renal cell carcinoma, and assessing whether FMT will prevent or mitigate immune-related adverse events. Dr. Fernandes details what led to the design and conduct of PERFORM. The study aim...
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- Christopher Wallis and Zachary Klaassen discuss the OMNIVORE study published in the Journal of Clinical Oncology. This phase II response-adaptive trial investigated the rational application of immune checkpoint blockade in renal cell carcinoma. Biographies: Christopher J.D. Wallis, MD, Ph.D., Assistant Professor in the Division of Urology at the University of Toronto. Zachary Klaassen, MD, MSc, Ur...
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