An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)

Summary

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.

Conditions

• Platinum-resistant Recurrent Ovarian Cancer

Interventions

DRUG

olaparib+cediranib combination therapy

Cediranib (30mg p.o. qd) + Olaparib (200mg p.o. bid) until disease progression

DRUG

durvalumab + olaparib combination therapy

Durvalumab (1500mg i.v. every 4 weeks starting on week 5 day1 for up to 12 months) + Olaparib (300mg p.o. bid) until disease progression

DRUG

durvalumab + chemotherapy treatment

Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + non-platinum-based standard of care chemotherapy (weekly paclitaxel, topotecan, or Pegylated liposomal doxorubicin(PLD) up to 6 cycles) Chemotherapy regimen: Weekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)

DRUG

durvalumab + tremelimumab + chemotherapy treatment

Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + Tremelimumab (75mg i.v. every 4 weeks for up to 4 doses) + non-platinum-based standard of care chemotherapy (weekly paclitaxel, topotecan, or Pegylated liposomal doxorubicin (PLD) up to 4 cycles) Chemotherapy regimen: Weekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)

DRUG

durvalumab + tremelimumab + paclitaxel treatment

Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + Tremelimumab (300mg i.v. once) + non-platinum-based standard of care chemotherapy (weekly paclitaxel up to 4 cycles) Chemotherapy regimen: Weekly Paclitaxel 60mg/m2 (day 1,8,15 every 4 weeks)

DRUG

durvalumab +chemotherapy treatment

Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + non-platinum-based standard of care chemotherapy (paclitaxel, topotecan, or Pegylated liposomal doxorubicin(PLD) up to 4 cycles) Chemotherapy regimen: Weekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)

Sponsors & Collaborators

• AstraZeneca

  collaborator INDUSTRY

• Samsung Genomic Institute

  collaborator UNKNOWN

• Seoul National University Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Korean Gynecologic Oncology Group

  collaborator OTHER

• Yonsei University

  lead OTHER

Principal Investigators

• Jung-Yun Lee, MD, Ph.D · Severance Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-26

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• South Korea

Study Locations