NCT05188781

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

Completed Last updated 12 January 2022

What this trial tests

trial testing Pembrolizumab combined Anlotinib in High-Grade Serous Ovarian Cancer in 34 participants. Completed in 23 August 2021.

Timeline

4 January 2019

Primary endpoint
23 August 2021

23 August 2021

Quick facts

Lead sponsor	The Affiliated Hospital of Qingdao University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	4 January 2019
Primary completion	23 August 2021
Estimated completion	23 August 2021
Sites	1 location across China

Drugs / interventions tested

• Pembrolizumab combined Anlotinib — full drug profile →

Conditions studied

• High-Grade Serous Ovarian Cancer — all drugs for High-Grade Serous Ovarian Cancer →

Sponsor

The Affiliated Hospital of Qingdao University

Who can join

18 and older, female only, with High-Grade Serous Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
2. Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
   Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845
3. Efficacy evaluation of multi-immunotherapy in ovarian cancer: From bench to bed.
   Hu X, Bian C, Zhao X, Yi T. · · 2022 · cited 19× · PMID 36275669 · DOI 10.3389/fimmu.2022.1034903
4. Gadolinium-Based Nanoparticles Sensitize Ovarian Peritoneal Carcinomatosis to Targeted Radionuclide Therapy.
   Garcia-Prada CD, Carmes L, Atis S, Parach A, et al · · 2023 · cited 8× · PMID 37857502 · DOI 10.2967/jnumed.123.265418
5. Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.
   Su Z, Zhang X, Xu J, Shen Y. · · 2026 · PMID 41983132 · DOI 10.3389/fimmu.2026.1686568