NCT04781088

Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase II Study With Safety Lead-In of Lenvatinib, Pembrolizumab, and Weekly Paclitaxel for Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Floor Backes, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial studies the effect of lenvatinib, pembrolizumab, and paclitaxel in treating patients with endometrial, epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). While all 3 study drugs are FDA approved, and 2-drug combinations have been studied, the 3- drug combination has not been studied yet. The investigators believe that the addition of pembrolizumab to weekly paclitaxel and lenvatinib (or weekly paclitaxel to pembrolizumab and lenvatinib) is highly effective and safe with manageable side effects in both recurrent endometrial and platinum resistant ovarian cancer. The purpose of this trial is to study how well lenvatinib, pembrolizumab, and weekly paclitaxel work together in women who have recurrent endometrial cancer and/or recurrent platinum resistant ovarian, fallopian tube, and primary peritoneal cancer, and what kind of side effects patients may experience.

Detailed description

PRIAMRY OBJECTIVE: I. To determine objective antitumor activity (complete and partial response) of lenvatinib, pembrolizumab, and weekly paclitaxel as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in recurrent endometrial and platinum resistant ovarian cancer. SECONDARY OBJECTIVES: I. To determine the safety and tolerability weekly paclitaxel, lenvatinib, and pembrolizumab in study patients. II. To measure the progression free survival in the study population. III. To measure the overall survival in the study population. EXPLORATORY OBJECTIVE: I. To explore the baseline tumor genetic and microenvironment parameters predictive of clinical benefit or resistance to the treatment combination and potential mechanisms of resistance. OUTLINE: Beginning cycle 1 day 1, patients receive lenvatinib PO daily, pembrolizumab IV on day 1, and paclitaxel IV over 1 hour on days 1, 8, and 15, on a 21 day cycle in the absence of disease progression or unacceptable toxicity.

Conditions

• Platinum-Resistant Fallopian Tube Carcinoma
• Platinum-Resistant Ovarian Carcinoma
• Platinum-Resistant Primary Peritoneal Carcinoma
• Recurrent Endometrial Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	Given PO
DRUG	Paclitaxel	Given IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-07-01
• Completion: 2026-08-31
• First posted: 2021-03-04
• Last updated: 2026-02-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study