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Ovarian Cancer Stage IIICPhase 2KGOG3046NCT03899610

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

A Phase 2 study testing Neoadjuvant chemotherapy+Durvalumab+Tremelimumab in people with Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV, run by Yonsei University at 4 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this trial is to evaluate the synergistic effects of durvalumab and tremelimumab plus chemotherapy in advanced-stage ovarian cancer. Ovarian cancer is the deadliest gynecologic cancer. The current standard therapy is surgical cytoreduction followed by taxane-platinum combination chemotherapy. Read more about this study

Who is it for?
Ages 20 years and older, women only
What is being tested?
Neoadjuvant chemotherapy+Durvalumab+Tremelimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
4 sitesSouth Korea
Study dates
4 Jul 2019to May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of ovary, fallopian tube, primary peritoneum
  • Clinical stage IIIC/IV
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Female aged 20 years older at the time of acquisition of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1
  • Must have life expectancy of at least 16 weeks
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  • Body weight >30kg
  • Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Platelet count ≥100 x 109/L
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). <<This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.>>
  • AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
  • Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
  • Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Participation in another clinical study with an investigational product during the last 60 days
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Any previous treatment with anti-PD-1, PD-L1, CTLA-4 (including durvalumab and tremelimumab)
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
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  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. <<amend as required based on any combination studies with other anticancer agents>>
  • Major surgical procedure (except diagnostic laparoscopy) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1/2 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years. Patients with a history of localised breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than two years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) << For durvalumab ±tremelimumab in combination with an agent with pro-arrhythmic potential or where effect of the combination on QT is not known if this criterion should be retained. Patient safety and the cardiac EKG should be consulted as needed>>.
  • History of active primary immunodeficiency

Trial locations and contacts

4 sites in 1 country.

Jung-Yun Lee, MD., Ph.D contact

82-2-2228-2230

jungyunlee@yuhs.ac

South Korea4 sites, 4 recruiting

  • National Cancer Center, Korea

    Gyeonggi-do

    Myong Cheol Lim, MD, PH.D, gynlim@gmail.com

    Not yet recruiting

  • Samsung Medical Center

    Seoul

    Byoung-Gie Kim, MD, PH.D, +82-2-3410-3513, bgkim@skku.edu

    Not yet recruiting

  • Seoul National University Hospital

    Seoul

    Jae-Woen Kim,, PH.D, +82-2-2072-3511, kjwksh@snu.ac.kr

    Recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul

    Jung-Yun Lee, MD, Ph.D, 82-2-2228-2230, JUNGYUNLEE@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

The primary objective of this trial is to evaluate the synergistic effects of durvalumab and tremelimumab plus chemotherapy in advanced-stage ovarian cancer.

Ovarian cancer is the deadliest gynecologic cancer. The current standard therapy is surgical cytoreduction followed by taxane-platinum combination chemotherapy. However, most patients with advanced-stage ovarian cancer will experience a relapse of disease. Therefore, there is an urgent need to improve outcomes of patients with this aggressive cancer.

Research hypothesis: Adding durvalumab and tremelimumab to current neoadjuvant chemotherapy (front-line therapy) in advanced-stage ovarian cancer can increase response rate and improve patient's outcome such as progression-free survival and overall survival with minimal effects on safety.

Being tested
Neoadjuvant chemotherapy+Durvalumab+Tremelimumab
Keywords
TRU-D
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemotherapy+Durvalumab+TremelimumabDrug

    1. Neoadjuvant treatment: Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing)
    2. Interval debulking surgery
    3. Adjuvant treatment:

    Standard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)

Study groups in NCT03899610
Study groupRoleWhat they receive
Neoadjuvant chemotherapy+Durvalumab+TremelimumabExperimental1. Neoadjuvant treatment: Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing) 2. Interval debulking surgery 3. Adjuvant treatment: Standard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)
Receives: Drug: Neoadjuvant chemotherapy+Durvalumab+Tremelimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival(PFS)

    12-months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

    Measured: 12 months

Secondary outcomes (7)

  1. Response rate

    Response rate by RECIST version 1.1 after neoadjuvant chemotherapy(after the completion of 3rd cycle)

    Measured: 9 weeks

  2. Immune-related response

    Immune-related response after neoadjuvant chemotherapy(after the completion of 3rd cycle)

    Measured: 9 weeks

  3. Response rate by PERCIST

    Response rate by PERCIST after neoadjuvant chemotherapy(after the completion of 3rd cycle)

    Measured: 9 weeks

  4. R0 rate

    R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)

    Measured: at interval debulking surgery after 9 weeks

  5. The rate of chemotherapy response score 3

    The rate of chemotherapy response score 3 after neoadjuvant chemotherapy(after the completion of 3rd cycle)

    Measured: 9 weeks

  6. Overall survival

    Overall survival up to 5 years

    Measured: up to 5 years

  7. Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy

    Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start4 Jul 2019
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is single arm phase II study to evaluate efficacy and safety of durvalumab and tremelimumab and chemotherapy in treatment-naïve clinical stage IIIC/IV ovarian cancer.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03899610
Sponsor's protocol ID
4-2019-0083
Other IDs
KGOG3046, ESR-17-13142
Acronym
KGOG3046
Status last verified
Sep 2020
First submitted
28 Mar 2019
Last updated
28 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park J, Lee JB, Lim MC, Kim BG, Kim JW, Kim S, Choi CH, Kim HS, Park SY, Lee JY; KGOG investigators. 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. J Immunother Cancer. 2023 Oct;11(10):e007444. doi: 10.1136/jitc-2023-007444.

    PubMed 37865397

  • Lee JY, Kim JW, Lim MC, Kim S, Kim HS, Choi CH, Yi JY, Park SY, Kim BG; KGOG investigators. 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. J Gynecol Oncol. 2019 Nov;30(6):e112. doi: 10.3802/jgo.2019.30.e112.

    PubMed 31576697

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant chemotherapy+Durvalumab+Tremelimumab in people with Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV, run by Yonsei University at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jung-Yun Lee, MD., Ph.D (82-2-2228-2230, jungyunlee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival(PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03899610, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.

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