Lenvatinib, Pembrolizumab, and Paclitaxel for the Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- 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
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 ...
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.
Tracking Information
- NCT #
- NCT04781088
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Floor Backes, MD Ohio State University Comprehensive Cancer Center