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Pembrolizumab and Anlotinib in the Treatment of High-Grade Serous Ovarian Cancer

NCT05188781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2022-01-12

No results posted yet for this study

Summary

Primary:

To evaluate improvement in progression-free survival for patients treated with anti-PD1 pembrolizumab in combination with Anlotinib as compared to pembrolizumab single treated Secondary: To obtain pilot data on clinical response rates using both RECIST1.1 criteria (Response Evaluation Criteria in Solid Tumors) and immune related response criteria (irRECIST).

Objectives • To obtain data on changes in tumor microenvironment prior to and subsequent to therapy and, to screen for potential biomarkers to predict clinical benefit combination in the study population.

* To assess the impact of the combination of anlotinib and pembrolizumab
* To determine the safety and tolerability of the treatment of anlotinib and pembrolizumab
* To evaluate overall survival in patients treated with anti-PD-1 pembrolizumab and anlotinib

Conditions

  • High-Grade Serous Ovarian Cancer

Interventions

DRUG

Pembrolizumab combined Anlotinib

Pembrolizumab 200 mg every 3 weeks, Anlotinib 12 mg/day, orally;2weeks treatment followed by 1week off

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2021-08-23
Completion
2021-08-23
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188781 on ClinicalTrials.gov