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

Sponsor
Yonsei University
Study ID
NCT03699449
Phase
PHASE2
Status
Unknown

Conditions

  • Platinum-resistant Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib+cediranib combination therapy — DRUG
    Cediranib (30mg p.o. qd) + Olaparib (200mg p.o. bid) until disease progression
  • durvalumab + olaparib combination therapy — DRUG
    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
  • durvalumab + chemotherapy treatment — DRUG
    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)
  • durvalumab + tremelimumab + chemotherapy treatment — DRUG
    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)
  • durvalumab + tremelimumab + paclitaxel treatment — DRUG
    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)
  • durvalumab +chemotherapy treatment — DRUG
    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)

Study Details

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.

Key Dates

Start date
Nov 26, 2018
Status verified
Mar 2021
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: olaparib + cediranib
    olaparib+cediranib combination therapy
  • Experimental: durvalumab + olaparib
    durvalumab + olaparib combination therapy
  • Experimental: durvalumab + chemotherapy
    durvalumab +chemotherapy
  • Experimental: durvalumab + tremelimumab + chemotherapy
    durvalumab + tremelimumab + chemotherapy
  • Experimental: durvalumab + tremelimumab + paclitaxel
    durvalumab + tremelimumab + paclitaxel
  • Experimental: durvalumab +chemotherapy
    durvalumab +chemotherapy

Primary Outcome Measure

objective response rate by RECIST 1.1 [ Time Frame: 6 months after treatment initiation ]

Central Contacts