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| Name | Class |
|---|---|
| Gynecologic Cancer Intergroup (GCIG) | OTHER |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
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The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the standard of care (SoC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Intervention: MEDI9447 (CD73) + durvalumab |
|
| Cohort B | Experimental | Intervention: MEDI0562 (OX40) + durvalumab |
|
| Cohort C | Experimental | Intervention: MEDI0562 (OX40) + tremelimumab combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 | Drug | Three different combination are being tested. Each cohort has different combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Disease control rate (DCR) (CR+PR+SD) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by RECIST v1.1 | PFS by RECIST v1.1 | 10 months |
| PFS by Immune-RECIST | PFS by Immune-RECIST | 10 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Mansoor R Mirza, MD | NSGO-CTU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | København Ø | Region Sjælland | 2100 | Denmark | ||
| VejleSygehus |
Upon request.
From December 2023.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.
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| Overall survival (OS) | Overall survival (OS) | 36 months |
| Objective response rate | Objective response rate according to RECIST v1.1 (ORR) | 10 months |
| Duration of (Overall) Response (DoR) | Duration of (Overall) Response (DoR) | 10 months |
| Vejle |
| Region Syddanmark |
| 7100 |
| Denmark |
| Tampere University Hospital | Tampere | Finland |
| Haukeland University Hospital | Bergen | Haukeland | 5021 | Norway |
| The Norwegian Radium Hospital | Oslo | 0310 | Norway |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |