NCT05832827

First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)

First-line Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: National Cancer Center, Japan · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II, investigator-initiated, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab combination for previously untreated advanced or recurrent thymic carcinomas

Detailed description

This is a phase II, investigator-initiated, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab combination for previously untreated advanced or recurrent thymic carcinomas. Induction chemotherapy consists of carboplatin + paclitaxel + pembrolizumab + lenvatinib for 3 weeks (21 days) as 1 cycle, up to a maximum of 4 cycles. Then, maintenance therapy with pembrolizumab and lenvatinib will be continued until progression or unacceptable adverse events.

Conditions

• Untreated Advanced or Recurrent Thymic Carcinomas

Interventions

Type	Name	Description
DRUG	MK-3475	Pembrolizumab will be administered at a dose of 200 mg by intravenous infusion every 21 days (3 weeks) for up to 35 cycles.
DRUG	Lenvatinib	Lenvatinib will be administered at a dose of 8 mg orally QD every 21 days (3 weeks) for up to 4 cycles in the induction phase, followed by 20 mg QD for up to 31 cycles in the maintenance phase. Then, further maintenance therapy with lenvatinib will be allowed until progression or unacceptable adverse events.
DRUG	Carboplatin	Carboplatin will be administered at a dose of AUC 5 intravenously every 21 days (3 weeks) for up to 4 cycles in the induction phase.
DRUG	Paclitaxel	Paclitaxel will be administered at a dose of 175 mg/m\^2 intravenously every 21 days (3 weeks) for up to 4 cycles in the induction phase.

Timeline

• Start date: 2023-09-04
• Primary completion: 2025-12-31
• Completion: 2028-06-30
• First posted: 2023-04-27
• Last updated: 2023-10-23

Locations

1 site across 1 country: Japan