CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 35 target
Drug / intervention
MK-3475 +3 moredrug
Likely dose
MK-3475 200 mgfrom record
Key inclusion· 11
  • Pathologically confirmed thymic carcinoma (primary or metastatic lesions)
  • CD5 or c-KIT positive preferred by immunohistochemistry
  • Unresectable advanced thymic carcinoma stage IVa/IVb (Masaoka-Koga), metastatic or recurrent, with no prior systemic chemotherapy
  • OR stage III (Masaoka-Koga) deemed incapable of radical resection or not eligible for curative chemoradiotherapy
Key exclusion· 36
  • Diagnosis of thymoma
  • Immune-related complications (myasthenia gravis, pure red cell aplasia, hypogammaglobulinemia)
  • Symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiotherapy or surgery
  • Prior VEGFR-targeting antiangiogenetic agent for thymic carcinoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05832827
NCT05832827Phase 2RecruitingUpdate OverdueUpdated 32mo ago · Completion was 6mo ago
Enrollment Stalled
Update Overdue

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

National Cancer Center, Japan·interventional·Posted Apr 27, 2023·Updated Oct 23, 2023

In Brief

A Phase 2 clinical trial evaluating MK-3475, Lenvatinib, and 2 other interventions for Untreated Advanced or Recurrent Thymic Carcinomas. Currently recruiting, targeting 35 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan

Timeline

Phase 2Recruiting
20242025202620272028
First PostedApr 27, 2023
Enrollment StartSep 4, 2023
Primary CompletionDec 31, 2025
Study CompletionJun 30, 2028
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 3.2 years ago

Interventions

MK-3475drug

Pembrolizumab will be administered at a dose of 200 mg by intravenous infusion every 21 days (3 weeks) for up to 35 cycles.

Lenvatinibdrug

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.

Carboplatindrug

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.

Paclitaxeldrug

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.