Abstract 254TiP
Background
Cabozantinib plus nivolumab (Cabo/Nivo) for patients with previously untreated advanced or metastatic clear cell renal cell carcinoma (ccRCC) demonstrated significant improvement of clinical outcomes, compared with sunitinib, in a randomized phase III trial (CheckMate-9ER). The results support Cabo/Nivo as standard regimen in global guidelines for those patients. However, limited numbers of Japanese patients were enrolled in the trial, and little information on the safety and efficacy in Japanese patients is available. Several previous studies, especially on vascular endothelial growth factor receptor (VEGFR) inhibitor-induced toxicity, have reported ethnic differences; therefore, it is important to clarify toxicity profiles in Japanese patients. Furthermore, there is limited information on this regimen for special populations in the real-world, such as patients with non-clear cell renal cell carcinoma (nccRCC) or those undergoing dialysis. This study evaluates the real-world efficacy and toxicity of Cabo/Nivo in Japanese patients with both ccRCC and nccRCC.
Trial design
We conducted a prospective observational study to evaluate Cabo/Nivo treatment in Japanese patients with advanced or metastatic RCC in the realworld. A total of 72 institutions throughout Japan have been participating in this study from April 2023. This study consists of two cohorts: cohort A (ccRCC) and cohort B (nccRCC). The target enrollment is 150 in cohort A and 50 in cohort B. Key inclusion criteria includes (1) histologically diagnosed with ccRCC or nccRCC, (2) clinically diagnosed with advanced or metastatic RCC, (3) patients received Cabo/Nivo, (4) previously untreated with systemic therapy (patients who recur more than 180 days after the last administration of adjuvant PD-1 or PD-L1 inhibitor therapy are allowed), (5) KPS score of ≥70%. Primary endpoint is overall response rate in each cohort, Secondary endpoints are progression-free survival, duration of response, overall survival, and safety in each cohort. Forty-three and 13 patients have been enrolled in cohorts A and B, respectively, as of July 2023.
Clinical trial identification
UMIN000050778.
Legal entity responsible for the study
Clinical Research Support Center Kyushu.
Funding
Takeda Pharmaceutical Company Limited.
Disclosure
Y. Miura: Financial Interests, Personal, Invited Speaker: Takeda, MSD, Bristol Myers Squibb, Ono Pharmaceutical, Merck BioPharma, Eisai, Astellas Pharma; Financial Interests, Institutional, Local PI: Ono Pharmaceutical, MSD. K. Fujita: Financial Interests, Personal, Other, Honoraria: Ono Pharmaceutical, Bristol Myers Squibb, Astellas, AstraZeneca. S. Tamada: Financial Interests, Personal, Speaker’s Bureau: Takeda, Pfizer, Merck-Biopharma, MSD. C. Ohe: Financial Interests, Personal, Other, Honoraria: Takeda, MSD KK, Ono Pharmaceutical. M. Eto: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Eisai, MSD, Ono Pharmaceutical, Takeda Pharmaceutical, Bristol Myers Squibb, Merck, Astellas Pharma, Pfizer, Janssen Pharmaceutical; Financial Interests, Personal, Advisory Role: Eisai, Pfizer, Takeda Pharmaceutical, Merck, Chugai Pharmaceutical; Financial Interests, Personal, Research Grant: Takeda Pharmaceutical. M. Oya: Financial Interests, Personal, Other, Honoraria: Astellas, Janssen, AstraZeneca, Takeda, Bayer, MSD; Financial Interests, Personal, Research Grant: Astellas. T. Kamba: Financial Interests, Personal, Other, Honoraria: Takeda Pharmaceutical, AstraZeneca, Merck Biopharma. N. Shinohara: Financial Interests, Personal, Other, Honoraria: MSD, Takeda, BMS, Ono, Eisai, Pfizer; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Research Grant: Ono, Takeda. T. Tsuzuki: Financial Interests, Personal, Other, Honoraria: MSD, Ono, Bristol Myers Squibb, Janssen, AstraZeneca, Nippon Kayaku, Takeda, Astellas, Bayer, Pfizer, Merck; Financial Interests, Personal, Advisory Role: Janssen, SBI, Ferring; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb. N. Nonomura: Financial Interests, Personal, Other, Honoraria: Takeda, Janssen, Merck Biopharma, Ono, Bristol; Financial Interests, Personal, Officer, Honoraria: AstraZeneca. Y. Fujii: Financial Interests, Personal, Advisory Role: Takeda Pharmaceuticals; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical, Takeda Pharmaceuticals. G. Kimura: Financial Interests, Personal, Other, Honoraria: Ono, BMS, Bayer, Merck Biopharma, MSD, Eisai, Takeda, Astellas, Janssen. H. Uemura: Financial Interests, Institutional, Research Grant: Astellas, Takeda, MSD, Janssen, Pfizer; Financial Interests, Institutional, Research Funding: AstraZeneca, Ono Pharmaceutical, Osaka Urology Research foundation; Financial Interests, Personal, Speaker, Consultant, Advisor: Takeda, Janssen, Pfizer, BMS, Sanofi, Bayer; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Role: Ono Pharmaceutical; Financial Interests, Personal, Project Lead: Chugai. All other authors have declared no conflicts of interest.
Resources from the same session
397P - Comparison between Y-site co-infusion versus standard dexamethasone for preventing hypersensitivity reactions from oxaliplatin administration: A randomized controlled trial
Presenter: jarearnjit Phavirunsiri
Session: Poster Display
Resources:
Abstract
398P - Evaluation of the effectiveness of denosumab therapy giant cell tumor of the pelvis
Presenter: Abbos Nurjabov
Session: Poster Display
Resources:
Abstract
399P - Long-term outcomes of patients with gastric cancer who received the best supportive care without any anticancer treatment
Presenter: Yohei Arihara
Session: Poster Display
Resources:
Abstract
401TiP - Oral opioid vs intravenous patient-controlled analgesia (PCA) with hydromorphone bolus-only or continuous infusion to maintain analgesia for severe cancer pain: A randomized phase III trial
Presenter: Cheng Huang
Session: Poster Display
Resources:
Abstract
407P - K-TrackTM: A streamlined personalized assay to detect molecular residual disease in solid tumors
Presenter: Nam Vo
Session: Poster Display
Resources:
Abstract
408P - Increased EGFR and MET expression and corresponding tumor microenvironment (TME) change in hepatocellular carcinoma (HCC) tissues after sorafenib (Sora) treatment
Presenter: Chia Jui Yen
Session: Poster Display
Resources:
Abstract
410P - Systematic evaluation of cell-free DNA fragmentation patterns for cancer diagnosis and enhanced cancer detection through integration of multiple fragmentations
Presenter: Xiangy-Yu Meng
Session: Poster Display
Resources:
Abstract
412P - Multiplex digital spatial profiling (DSP) of protein reveals distinct immune and molecular phenotypes in hepatocellular carcinoma
Presenter: Chia Jui Yen
Session: Poster Display
Resources:
Abstract
413P - Clinical utility of advanced features provided by circulating tumor DNA-based comprehensive genomic profiling
Presenter: Young-gon Kim
Session: Poster Display
Resources:
Abstract
414P - Landscape of ERBB2 mutations in advanced cancers (AC) using circulating tumor DNA (ctDNA) next-generation sequencing (NGS) in Asia and Middle East (AME)
Presenter: Byoung Chul Cho
Session: Poster Display
Resources:
Abstract