Trial in Patients With Relapsed Ovarian Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03267589 |
Recruitment Status :
Completed
First Posted : August 30, 2017
Last Update Posted : September 11, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer |
Actual Study Start Date : | May 14, 2018 |
Actual Primary Completion Date : | October 19, 2021 |
Actual Study Completion Date : | October 19, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort A
Intervention: MEDI9447 (CD73) + durvalumab
|
Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination |
Experimental: Cohort B
Intervention: MEDI0562 (OX40) + durvalumab
|
Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination |
Experimental: Cohort C
Intervention: MEDI0562 (OX40) + tremelimumab combination
|
Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination |
- Disease control rate (DCR) [ Time Frame: 16 weeks ]Disease control rate (DCR) (CR+PR+SD)
- Progression-Free Survival (PFS) by RECIST v1.1 [ Time Frame: 10 months ]PFS by RECIST v1.1
- PFS by Immune-RECIST [ Time Frame: 10 months ]PFS by Immune-RECIST
- Overall survival (OS) [ Time Frame: 36 months ]Overall survival (OS)
- Objective response rate [ Time Frame: 10 months ]Objective response rate according to RECIST v1.1 (ORR)
- Duration of (Overall) Response (DoR) [ Time Frame: 10 months ]Duration of (Overall) Response (DoR)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Platinum-sensitive disease: defined as disease progression ≥ 6 months following the last administered dose of platinum-based therapy. Patients must have received atleast one line of chemotherapy for platinum-sensitive disease. OR
-
Platinum-resistant disease: defined as disease progression < 6 months following the last administered dose of platinum-based therapy.
OR
-
Platinum-refractory disease: defined as lack of response or disease progression while receiving the most recent therapy.
Other key inclusion criteria:
- Histological confirmed ovarian, fallopian tube or peritoneal cancers.
- Histological types: high-grade serious, high-grade endometriod, undifferentiated, carcinosarcoma or mixed histology.
- Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This should not be the same lesion used for biopsy.
- Patients entering cohort A: Archival tumour tissue must be screened for CD73 and only CD73 positive patients (defined as >10% of tumor cells positive) will enter this trial.
- Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations according to protocol.
- Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.
- Patients must give informed consent.
- Patients must be at least 18 years of age.
- ECOG performance status 0-1
- Serum albumin >30g/l.
- Adequate organ function
- Life expectancy of at least 12 weeks.
- Patients must be fit to receive Investigational medical products (IMPs)
Exclusion Criteria:
- Subjects using immunosuppressive medications within 14 days.
- Immunodeficiency or organ transplant
- Live vaccines within 28 days prior to the first dose.
- Major surgery within 28 days prior to the first dose.
- Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers.
- Cancer therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within 28 days prior to the first dose.
- Concurrent treatment with an investigational agent or participation in another clinical trial.
- Previous malignant disease: patients are not eligible for the study if actively being treated of inva-sive cancer other than ovarian cancer. Patients with previous malignant disease other than ovarian cancer who are relapse-free and treatment-free for more than three years may enter this study. Pa-tients with previous history of in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
- Active infection including tuberculosis
- History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months.
- History of clinically significant hemorrhage in the past 3 months.
- Untreated CNS disease, leptomeningeal disease or cord compression. Subjects with treated dis-ease should have at least 4 weeks of neurologic and radiographic stability and be off steroids for 14 days.
- Significant cardiovascular disease's.
- Persistance of clinically relevant therapy related toxicity from previous anticancer therapy (any grade 3-4 toxicity or grade ≥2 neuropathy).
- Known hypersensitivity to the trial drugs, or to their excipients.
- Has had prior exposure to IMPs, or any other immunotherapy.
- Active or prior documented autoimmune or inflammatory disorders
- For cohorts B and C: Medical condition requiring current systemic anticoagulation, or a history of congenital hypercoagulable condition. Subjects taking aspirin at doses < 325 mg per day are eli-gible provided that prothrombin time is within the institutional range of normal. Use of local anti-coagulation for port maintenance is permitted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267589
Denmark | |
VejleSygehus | |
Vejle, Region Syddanmark, Denmark, 7100 | |
Rigshospitalet | |
København Ø, Sjaelland, Denmark, 2100 | |
Finland | |
Tampere University Hospital | |
Tampere, Finland | |
Norway | |
Haukeland University Hospital | |
Bergen, Haukeland, Norway, 5021 | |
The Norwegian Radium Hospital | |
Oslo, Norway, 0310 |
Study Director: | Mansoor R Mirza, MD | NSGO-CTU |
Responsible Party: | Nordic Society of Gynaecological Oncology - Clinical Trials Unit |
ClinicalTrials.gov Identifier: | NCT03267589 |
Other Study ID Numbers: |
ENGOT-OV30 / NSGO |
First Posted: | August 30, 2017 Key Record Dates |
Last Update Posted: | September 11, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Upon request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | From December 2023. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
immunotherapy ovarian cancer durvalumab |
tremelilumab MEDI 9447 MEDI 0562 |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents |