ABSTRACT
Background: Cabozantinib is an approved therapy for advanced RCC (in the USA) and in treatment-naive patients with intermediate/poor risk, as well as following VEGF-targeted therapy (in Europe). Trial design: Cabopoint (NCT03945773) is a phase II, open-label study of cabozantinib in adults with unresectable, locally advanced or metastatic clear-cell RCC, whose disease progressed after checkpoint inhibitor therapy with ipilimumab and nivolumab alone (cohort A) or in combination with VEGF-targeted therapy (cohort B). The primary endpoint is objective response rate. Secondary endpoints include time to response, duration of response, disease control rate, progression-free survival and overall survival. A target of 250 patients at 50 European sites will receive cabozantinib (60 mg once daily;self-administered at home) for ≤ 18 months after the last patient receives their first dose. Safety assessments will occur every 2 weeks up to week 4, then every 4 weeks. Patients may continue cabozantinib after disease progression if there is clinical benefit. During follow-up, patients who discontinue early will be contacted every 12 weeks to assess survival and subsequent therapy. Each cohort will have an interim analysis when 60% of patients reach 12 months of follow-up. Cabopoint has been adjusted to allow the trial to continue during the COVID-19 outbreak, protecting participants in compliance with the study protocol.1 Alternative arrangements include: study drug dispensation to the participant's home if they cannot attend the study site;safety assessments at the study site or remotely at a local health care provider, within the protocol defined window;tumour assessments at a local radiology facility if they cannot attend the study site. Enrolment is permitted if the patient can be managed in compliance with the protocol and alternative arrangements.1 The limitations, risks and impact on data privacy of such arrangements will be accounted for and documented.
ABSTRACT
Background: Cabozantinib is an approved therapy for advanced RCC (in the USA) and in treatment-naïve patients with intermediate/poor risk, as well as following VEGF-targeted therapy (in Europe). Trial design: CaboPoint (NCT03945773) is a phase II, open-label study of cabozantinib in adults with unresectable, locally advanced or metastatic clear-cell RCC, whose disease progressed after checkpoint inhibitor therapy with ipilimumab and nivolumab alone (cohort A) or in combination with VEGF-targeted therapy (cohort B). The primary endpoint is objective response rate. Secondary endpoints include time to response, duration of response, disease control rate, progression-free survival and overall survival. A target of 250 patients at 50 European sites will receive cabozantinib (60 mg once daily;self-administered at home) for ≤ 18 months after the last patient receives their first dose. Safety assessments will occur every 2 weeks up to week 4, then every 4 weeks. Patients may continue cabozantinib after disease progression if there is clinical benefit. During follow-up, patients who discontinue early will be contacted every 12 weeks to assess survival and subsequent therapy. Each cohort will have an interim analysis when 60% of patients reach 12 months of follow-up. CaboPoint has been adjusted to allow the trial to continue during the COVID-19 outbreak, protecting participants in compliance with the study protocol.1 Alternative arrangements include: study drug dispensation to the participant’s home if they cannot attend the study site;safety assessments at the study site or remotely at a local health care provider, within the protocol defined window;tumour assessments at a local radiology facility if they cannot attend the study site. Enrolment is permitted if the patient can be managed in compliance with the protocol and alternative arrangements.1 The limitations, risks and impact on data privacy of such arrangements will be accounted for and documented. Clinical trial identification: NCT03945773. Editorial acknowledgement: Dr Tamzin Gristwood of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen, in accordance with Good Publication Practice guidelines. Legal entity responsible for the study: Ipsen. Funding: Ipsen. Disclosure: L. Albiges: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS;Advisory/Consultancy, Travel/Accommodation/Expenses: MSD;Advisory/Consultancy: Novartis;Advisory/Consultancy: Amgen;Advisory/Consultancy: Ipsen;Advisory/Consultancy: Roche;Advisory/Consultancy: Pfizer;Advisory/Consultancy: Merck;Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: Exelixis;Advisory/Consultancy: Peloton Therapeutics;Advisory/Consultancy: Corvus Pharmaceuticals. M. Schmidinger: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy: Novartis;Honoraria (self), Advisory/Consultancy: BMS;Honoraria (self), Advisory/Consultancy: MSD;Honoraria (self), Advisory/Consultancy: Merck;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: EUSA;Honoraria (self), Advisory/Consultancy: Ipsen;Honoraria (self), Advisory/Consultancy: Exelixis;Honoraria (self), Advisory/Consultancy: EISAI;Honoraria (self), Advisory/Consultancy: Alkermes. N. Taguieva-Pioger: Full/Part-time employment: Ipsen. D. Perol: Honoraria (self): Roche;Honoraria (self): BMS;Honoraria (self): MSD;Honoraria (self): Ipsen;Honoraria (self): Pierre Fabre;Honoraria (self): Novartis;Honoraria (self): Takeda;Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca;Research grant/Funding (institution): MSD Avenir. V. Gruenwald: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options: AstraZeneca;Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock opt ons: BMS;Honoraria (self), Research grant/Funding (institution), Shareholder/Stockholder/Stock options: MSD;Honoraria (self): Roche;Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Ipsen;Honoraria (self), Travel/Accommodation/Expenses: Bayer;Honoraria (self): Merck Serono;Honoraria (self): Janssen-Cilag;Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Honoraria (self): Lilly;Honoraria (self): PharmaMar;Honoraria (self), Research grant/Funding (institution): Novartis;Honoraria (self): EUSAPharm;Honoraria (self): Eisai.