Recruitment

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