A phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in advanced-stage ovarian cancer: a Korean Gynecologic Oncology Group Study (KGOG 3046), TRU-D

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Abstract

Background

A single-arm phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in the treatment of advanced-stage ovarian cancer has begun in Korea. We hypothesized that adding durvalumab (anti-programmed death-ligand 1 antibody) and tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4 antibody) to chemotherapy in treating this cancer can increase progression-free survival (PFS) with minimal effects on safety.

Methods

During treatment, serial biopsies will be performed on pre-treatment, at interval debulking surgery and progression to identify immune biomarkers and changes in the tumor microenvironment. Patients with histologically confirmed stage IIIC/IV epithelial ovarian cancer are offered durvalumab, tremelimumab plus chemotherapy for neoadjuvant chemotherapy and durvalumab plus chemotherapy for adjuvant chemotherapy. Twenty-four patients will be included from four Korean institutions within 1 year. The primary endpoint is a 12-month PFS rate.

Trial Registration

ClinicalTrials.gov Identifier: NCT03899610

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Most cited references 5

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Comparison of treatment invasiveness between upfront debulking surgery versus interval debulking surgery following neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers in a phase III randomised trial: Japan Clinical Oncology Group Study JCOG0602.

Takashi Onda, Toyomi Satoh, Toshiaki Saito … (2016)

We conducted a phase III, non-inferiority trial comparing upfront primary debulking surgery (PDS) and interval debulking surgery (IDS) following neoadjuvant chemotherapy (NAC) for stage III/IV ovarian, tubal, and peritoneal cancers (JCOG0602). Two earlier studies, EORTC55971 and CHORUS, demonstrated non-inferior survival of patients treated with NAC. However, they could not evaluate true treatment invasiveness because of adding diagnostic laparotomy or laparoscopy before treatment in over 30% of both arms of EORTC55971 and in 16% of NAC arm of CHORUS.

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Expression of programmed cell death ligand 1 and immune checkpoint markers in residual tumors after neoadjuvant chemotherapy for advanced high-grade serous ovarian cancer

Hyun-Soo Kim, Ji-Ye Kim, Yong Jae Lee … (2018)

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Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer

Kathleen Moore, Sandro Pignata (2019)

There is mounting pre-clinical and clinical evidence that combinations of immunotherapy, specifically programed cell death-1 (PD-1) inhibition, with chemotherapy and anti-angiogenesis agents, such as bevacizumab, result in markedly improved outcomes across a variety of tumor types including endometrial cancer, renal cell cancer, and non-small cell lung cancer. IMagyn050/GOG 3015/ENGOT-OV39 is the first, randomized, phase III trial to evaluate the potential impact of this combination on both progression-free survival and overall survival in patients presenting with advanced epithelial ovarian cancer. The primary objective is to evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel + carboplatin + bevacizumab for front-line treatment of ovarian cancer among all patients and those with PD-L1+ tumors. This study will test the hypothesis that treatment with atezolizumab added to paclitaxel, carboplatin, and bevacizumab will prolong progression-free survival and overall survival compared with treatment with placebo plus paclitaxel, carboplatin, and bevacizumab. This is a randomized, phase III, placebo-controlled study. Eligible patients have a histologic diagnosis of advanced epithelial ovarain cancer, primary peritoneal, or fallopian tube cancer who either have residual disease after primary surgery or who are undergoing neoadjuvant chemotherapy with planned interval surgery. Ineligible patients include those who are cured with surgery alone or those for whom no gross residual disease remained following primary cytoreduction. There are two co-primary efficacy endpoints: investigator-assessed progression-free survival and overall survival. 1300 patients. April 2020. NCT03038100 .

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Author and article information

Journal

Journal ID (nlm-ta): J Gynecol Oncol

Journal ID (iso-abbrev): J Gynecol Oncol

Journal ID (publisher-id): JGO

Title: Journal of Gynecologic Oncology

Publisher: Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology

ISSN (Print): 2005-0380

ISSN (Electronic): 2005-0399

Publication date Collection: November 2019

Publication date (Electronic): 03 September 2019

Volume: 30

Issue: 6

Electronic Location Identifier: e112

Affiliations

[1 ]Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.

[2 ]Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.

[3 ]Division of Tumor Immunology and Center for Clinical Trial, Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.

[4 ]Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

[5 ]R connect, Seoul, Korea.

Author notes

Correspondance to Byoung-Gie Kim. Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea. bgkim@ 123456skku.edu

^*Additional KGOG investigators who participated in this study are listed in the acknowledgments.

Author information

Jung-Yun Lee https://orcid.org/0000-0001-7948-1350

Jae Weon Kim https://orcid.org/0000-0003-1835-9436

Myong Cheol Lim https://orcid.org/0000-0001-8964-7158

Sunghoon Kim https://orcid.org/0000-0002-1645-7473

Hee Seung Kim https://orcid.org/0000-0001-6876-8671

Chel Hun Choi https://orcid.org/0000-0002-0199-6669

Ju Yeon Yi https://orcid.org/0000-0002-4423-1076

Sang-Yoon Park https://orcid.org/0000-0001-8325-6009

Byoung-Gie Kim https://orcid.org/0000-0002-0572-8450

Article

Publisher ID: 2019300621

DOI: 10.3802/jgo.2019.30.e112

PMC ID: 6779618

PubMed ID: 31576697

SO-VID: fca48c50-f7ca-46de-9937-e8c731514f5a

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 09 July 2019

Date revision received : 18 August 2019

Date accepted : 21 August 2019

Funding

Funded by: AstraZeneca Korea, CrossRef https://doi.org/10.13039/501100004599;

Funded by: Yonsei University College of Medicine, CrossRef https://doi.org/10.13039/501100008005;

Award ID: 6-2018-0169

Funded by: Ministry of Science, ICT and Future Planning, CrossRef https://doi.org/10.13039/501100003621;

A phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in advanced-stage ovarian cancer: a Korean Gynecologic Oncology Group Study (KGOG 3046), TRU-D

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Abstract

Background

Methods

Trial Registration

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Karger: Oncology

Most cited references 5

Comparison of treatment invasiveness between upfront debulking surgery versus interval debulking surgery following neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers in a phase III randomised trial: Japan Clinical Oncology Group Study JCOG0602.

Expression of programmed cell death ligand 1 and immune checkpoint markers in residual tumors after neoadjuvant chemotherapy for advanced high-grade serous ovarian cancer

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