Evidence mapPaperPMID 37865397Full record

Trial reportJournal for immunotherapy of cancer2023

Phase II study of durvalumab and tremelimumab with front-line neoadjuvant chemotherapy in patients with advanced-stage ovarian cancer: primary analysis in the original cohort of KGOG3046/TRU-D.

Junsik Park, Jung Bok Lee, Myong Cheol Lim, Byoung-Gie Kim, Jae-Weon Kim, Sunghoon Kim, Chel Hun Choi, Hee Seung Kim, Sang Yoon Park, Jung-Yun Lee and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03899610 (A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03899610 phase2unknown statusnot on this map

A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)

TypeinterventionalSponsorYonsei UniversityRan2019 to 2021Enrolled24ConditionsOvarian Cancer Stage IIIC, Ovarian Cancer Stage IVArmsNeoadjuvant chemotherapy+Durvalumab+Tremelimumab
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Genomics of ovarian cancers and the potential of precision medicine.Therapeutic advances in medical oncology · 2025
    Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Junsik ParkDepartment of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-4094-2097
Jung Bok LeeDepartment of Clinical Epidemiology & Biostatistics, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Myong Cheol LimGynecologic Cancer Branch & Center for Uterine Cancer, National Cancer Center, Goyang, Republic of Korea.
Byoung-Gie KimDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Jae-Weon KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sunghoon KimDepartment of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea.
Chel Hun ChoiDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Hee Seung KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sang Yoon ParkGynecologic Cancer Branch & Center for Uterine Cancer, National Cancer Center, Goyang, Republic of Korea.
Jung-Yun LeeDepartment of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea yodrum682@gmail.com.ORCID 0000-0001-7948-1350
KGOG investigators
Seoul National University · KRUlsan College · KRYonsei University · KRSamsung Medical Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study assessed the antitumor activity and safety of durvalumab plus tremelimumab combined with neoadjuvant chemotherapy (NAC) in patients newly diagnosed with advanced ovarian cancer. Here, we report the primary endpoint of the original cohort of the KGOG 3046/TRU-D study.

methodsIn this investigator-initiated single-arm, phase II trial, patients with stage IIIC-IVB ovarian cancer were administered three cycles of durvalumab (1500 mg) and tremelimumab (75 mg) with NAC, followed by interval debulking surgery (IDS). After surgery, three cycles of durvalumab (1120 mg) and adjuvant chemotherapy followed by durvalumab maintenance (1120 mg [total 12 cycles]) were administered. The primary endpoint of the study was 12-month progression-free survival (PFS) rate.

resultsTwenty-three patients were enrolled. The median patient age was 60 years (range 44-77 years), and most patients presented with high-grade serous carcinoma (87.0%) and stage IV disease (87.0%). At the time of data cut-off on January 17, 2023, the median follow-up duration was 29.2 months (range 12.0-42.2). The 12-month, 24-month, and 30 month PFS rates were 63.6%, 45.0%, and 40.0%, respectively. All patients underwent IDS, with an R0 resection rate of 73.9%, and 17.4% achieved pathological complete response. Skin rashes were the most common treatment-related adverse events (TRAEs, 69.6%). However, all TRAEs completely resolved after steroid use.

conclusionThis study showed promising activity with a durable clinical response, supporting the potential of NAC with dual immune checkpoint blockade in advanced-stage ovarian cancer. TRIAL REGISTRATION NUMBER: NCT03899610.

Indexed as

Neoadjuvant TherapyOvarian NeoplasmsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialFemaleHumansMiddle AgedNeoplasm StagingAntibodies, MonoclonalAntibodies, Monoclonal, Humanizeddurvalumabtremelimumabclinical trials, phase II as topicimmune checkpoint inhibitorsimmunotherapyprogrammed cell death 1 receptor

Identifiers

PMID37865397
PMCPMC10603354
OpenAlexW4387849987

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.