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Clinical Trial Summary

- Clinical Indication : Advanced adrenal cortical carcinoma after platinum-based chemotherapy - Trial Type : Single arm, prospective trial - Route of administration : Intravenous (pembrolizumab) and peroral (lenvatinib) - Treatment Groups : Single arm - Number of trial participants : 30


Clinical Trial Description

1. Timing of Dose Administration for Pembrolizumab Trial interventions should be administered on Day 1 of each cycle after all procedures/assessments have been completed as detailed on the Schedule. Trial interventions may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. All trial interventions will be administered on an outpatient basis. Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min). 2. Lenvatinib administration Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. Treatment cycles will be counted continuously regardless of dose interruptions. On Day 1 (D1) of each cycle, it will be administered approximately 1 hour after completion of pembrolizumab administration. 3. Treatment Period The Treatment Phase will begin with the administration of the first dose of study treatment to the first subject in Cycle 1 and continues in 21-day (3-week) cycles. Subjects will continue to receive study treatment until confirmed PD by IIR, development of unacceptable toxicity, subject request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or study termination by the sponsor. Those subjects that discontinue study treatment transition to the Off-Tx Visit of the Follow-up Period. 4. Safety Follow-Up Visit The mandatory Safety Follow-Up Visit should be conducted approximately 30 days after the last dose of study intervention or before the initiation of a new anti-cancer treatment, whichever comes first. 5. Efficacy Follow-up Visits Participants who complete the protocol-required cycles of study intervention of who discontinue study intervention for a reason other than disease progression will begin the Efficacy Follow-Up Phase and should be assessed every 6 weeks (42 ± 7 days) by radiologic imaging to monitor disease status. After 6 months, the imaging time point will occur every 9 weeks (± 7 days). Every effort should be made to collect information regarding disease status until the start of new anti-cancer therapy, disease progression, death, end of the study. Information regarding post-study anti-cancer treatment will be collected if new treatment is initiated. Participants who completed all efficacy assessments and/or will not have further efficacy assessments must enter the Survival Follow-up Phase. 6. Time Period and Frequency for Collecting AE, SAE, and Other Reportable Safety Event Information : All AEs, SAEs, and other reportable safety events that occur after the consent form is signed but before intervention allocation must be reported by the investigator if the event cause the participant to be excluded from the study, or is the result of a protocol-specified intervention, including but not limited to washout or discontinuation of usual therapy, diet, or a procedure. - All AEs from the time of intervention allocation through 30 days following cessation of study intervention must be reported by the investigator. - All AEs meeting serious criteria, from the time of intervention allocation through 90 days following cessation of study intervention or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, must be reported by the investigator. - All pregnancies and exposure during breastfeeding, from the time of intervention allocation through 120 days following cessation of study intervention, or 30 days following cessation of study intervention if the participant initiates new anticancer therapy must be reported by the investigator. - Additionally, any SAE brought to the attention of an investigator at any time outside of the time period specified above must be reported immediately to MSD if the event is considered drug-related. Investigators are not obligated to actively seek AEs or SAEs or other reportable safety events in former study participants. However, if the investigator learns of any SAE, including a death, at any time after a participant has been discharged from the study, and he/she considers the event to be reasonably related to the study intervention or study participation, the investigator must promptly notify MSD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036434
Study type Interventional
Source National Cancer Center, Korea
Contact Hyunjung Park
Phone +82-31-920-0950
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 1, 2021
Completion date August 31, 2026

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