CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 24 target
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 mgfrom record
Key inclusion· 9
  • ✓Female, at least 18 years of age
  • ✓Histologically-confirmed epithelial ovarian cancer, excluding low-grade tumors and mucinous histology
  • ✓Measurable disease at baseline per RECIST 1.1
  • ✓ECOG performance status 0 to 1
Key exclusion· 31
  • ✕Positive urine pregnancy test
  • ✕Pregnant, breastfeeding, or expecting to conceive within study duration through 120 days after last dose
  • ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell co-inhibitory agents within 6 months
  • ✕Prior systemic anti-cancer therapy within 4 weeks (or 5 half-lives for TKIs/hormonal therapy)

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

Search/NCT04519151
NCT04519151Phase 2RecruitingUpdate OverdueUpdated 36mo ago · Completion was 31mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer

Sheba Medical Center·interventional·Posted Aug 19, 2020·Updated Jun 8, 2023

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Lenvatinib for Ovarian Neoplasms and 7 related conditions. Currently recruiting, targeting 24 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms, Carcinoma, Ovarian Epithelial, Neoplasm of Stomach, Ovarian Diseases, Genital Neoplasms, Female, Ovarian Epithelial Tumor, Urogenital Neoplasms, Neoplasms, Glandular and Epithelial
CountriesIsrael
Collaborators--

Timeline

Phase 2Recruiting
2021202220232024202520262027202820292030
First PostedAug 19, 2020
Enrollment StartApr 12, 2021
Primary CompletionNov 1, 2023
Study CompletionNov 1, 2029
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.9 years ago

Interventions

Pembrolizumabdrug

200 mg administered by IV infusion on Day 1 of each 21-day cycle.

Lenvatinibdrug

20 mg administered orally (PO) QD during each 21-day cycle.