254TiP - Prospective observational trial of cabozantinib plus nivolumab in Japanese patients with advanced or metastatic renal cell carcinoma: JACUMET trial

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.