NCT04885413

An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1（Programmed Cell Death Protein 1） Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients

Status unknown Phase 2 Last updated 23 August 2021

What this trial tests

Phase 2 trial testing Niraparib in Combination With Anti-PD1 Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients in 37 participants. Status unknown.

Timeline

1 July 2021

Primary endpoint
30 August 2022

1 June 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 July 2021
Primary completion	30 August 2022
Estimated completion	1 June 2023
Sites	1 location across China

Drugs / interventions tested

• Niraparib in Combination With Anti-PD1 Antibody — full drug profile →

Conditions studied

• Recurrent/ Advanced Stage Endometrial Cancer Patients — all drugs for Recurrent/ Advanced Stage Endometrial Cancer Patients →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, female only, with Recurrent/ Advanced Stage Endometrial Cancer Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endometrial carcinoma is the most common malignancy of the female reproductive tract. Most cases are diagnosed at an early stage due to the appearance of symptoms such as postmenopausal bleeding. However, endometrial carcinoma carries a poor prognosis when it recurs after previous definitive treatment or when diagnosed at an advanced stage.The 5-year survival rate for FIGO III is approximately 57-66% and for FIGO IV is approximately 10-20%.The combination of PARP（poly adenosine diphosphate-ribose polymerase）inhibitors and PD1/PD-L1 has the theoretical support of preclinical molecular biology. In recent years, a large number of basic studies and preclinical models have confirmed that this combination therapy has superimposed or even synergistic effects on multiple levels.This study intends to explore the efficacy and safety of anti-PD-1 antibody combined with niraparib in the treatment of recurrent or advanced endometrial cancer.

Publications & conference data

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

1. The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
   Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
2. Phase II trial of efficacy, safety and biomarker analysis of sintilimab plus anlotinib for patients with recurrent or advanced endometrial cancer.
   Wei W, Ban X, Yang F, Li J, et al · · 2022 · cited 28× · PMID 35623659 · DOI 10.1136/jitc-2021-004338
3. Immune Environment and Immunotherapy in Endometrial Carcinoma and Cervical Tumors.
   Lainé A, Gonzalez-Lopez AM, Hasan U, Ohkuma R, et al · · 2023 · cited 10× · PMID 37046702 · DOI 10.3390/cancers15072042