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An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)
This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients. This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.
Details
| Lead sponsor | Yonsei University |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 104 |
| Start date | 2018-11-26 |
| Completion | 2022-09 |
Conditions
- Platinum-resistant Recurrent Ovarian Cancer
Interventions
- olaparib+cediranib combination therapy
- durvalumab + olaparib combination therapy
- durvalumab + chemotherapy treatment
- durvalumab + tremelimumab + chemotherapy treatment
- durvalumab + tremelimumab + paclitaxel treatment
- durvalumab +chemotherapy treatment
Primary outcomes
- objective response rate by RECIST 1.1 — 6 months after treatment initiation
The primary endpoint of the study is objective response rate by RECIST 1.1 (Time frame: up to 6 months after treatment initiation)
Countries
South Korea