Lenvatinib, Pembrolizumab, and Paclitaxel for the Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT04781088|
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : August 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Lenvatinib Drug: Paclitaxel Biological: Pembrolizumab||Phase 2|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study With Safety Lead-In of Lenvatinib, Pembrolizumab, and Weekly Paclitaxel for Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||February 9, 2025|
Experimental: Treatment (paclitaxel, lenvatinib, pembrolizumab)
Patients receive paclitaxel IV over 1 hour on days -15 and -8 and lenvatinib PO QD on days -15 to 0. Beginning cycle 1 day 1, patients receive lenvatinib PO QD, pembrolizumab IV over 30 minutes on day 1, and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles with pembrolizumab repeats every 3 weeks for up to 2 years, and cycles with paclitaxel and lenvatinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
- Objective tumor response [ Time Frame: through study completion, an average of 1 year ]Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. Will be reported as a percentage and will be calculated by the number of patients with a complete or partial response divided by the total number of patients. The percentage of patients with stable disease and progressive disease will be calculated in a similar fashion.
- Safety and Toxicity [ Time Frame: through study completion, an average of 1 year ]Toxicity as assessed by Common Terminology for Adverse Events version 5.0 will be evaluated descriptively using frequencies and percentages and will be reported using tables. All patients who receive treatment, regardless of eligibility, will be evaluated for toxicity. Toxicities by type and maximum grade over the course of treatment and follow up will be summarized and by date of occurrence.
- Progression free survival [ Time Frame: through study completion, an average of 1 year ]Time from first therapy to the time of cancer progression, death or lost to follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781088
|Contact: The Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Kelly Dodd||614-366-8986||Kelly.Dodd@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Contact: Floor Backes, MD 614-293-7642 Floor.firstname.lastname@example.org|
|Principal Investigator: Floor Backes, MD|
|Principal Investigator:||Floor Backes, MD||Ohio State University Comprehensive Cancer Center|