WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
ConditionEpithelial Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAGO Research GmbH
About this trial
This is a multi-center, prospective, open-label, phase II trial. Patients with suspected advanced ovarian cancer planned to undergo diagnostic laparoscopy for histologic confirmation and evaluation of disease spread will be registered into the trial after providing a 1st written informed consent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with presumed and previously untreated advanced stage ovarian cancer planned to undergo laparoscopy for histologic diagnosis and treatment planning
Patients willing and able to comply with the study protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patients able and willing to provide fresh frozen biopsy samples from laparoscopy as well as primary debulking for translational endpoints as well as serial liquid biopsies
Patients able and willing to provide formaldehyde-fixed paraffin embedded (FFPE) tissue samples from laparoscopy and primary debulking surgery
Disqualifiers
Disease requiring urgent surgical intervention
Evidence of significant uncontrolled concomitant disease that could affect compliance with the study protocol
Significant uncontrolled symptom burden (e.g. but not necessarily limited to large volume ascites, shortness of breath on exertion, pain requiring opioid medication, signs of (sub)ileus
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, recent (within 3 months) myocardial infarction, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
Trial design
Design model
Sequential
Treatments tested in this trial
olaparib
DrugOlaparib tablets are administrated orally 300 mg twice daily.
durvalumab
DrugDurvalumab is administered 1500mg iv as a single dose prior to surgery (corresponding to 1 single cycle) .
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: cohort A - olaparib monotherapyOther 1 intervention
Group B: cohort B - olaparib + durvalumab combinationOther 2 interventions
Trial outcomes
Primary outcomes
1
Feasibility of the WoO procedure for olaparib alone (cohort a) & olaparib in combination with durvalumab (cohort b)
Defined as the successful completion of the WoO therapy: * Relative dose intensity (RDI) of ≥80% * No treatment-related surgical delays * Adherence to therapeutic strategy * Lack of clinical progression prior to primary debulking surgery * No treatment-related toxicities of any grade that in the judgment of the investigator or surgeon significantly interfered with the subject's optimal perioperative management
Time frame
Between registration into the trial until 60 days after surgery or 60 days after the originally planned surgery date in case of switch of therapeutic strategy.Secondary outcomes
1
Safety of the WoO procedure
Evaluated by the proportion of patients who experience any adverse event (CTCAE v5.0), of a grade ≥3.
Time frame
Between registration into the trial until 60 days after surgery or 60 days after the originally planned surgery date in case of switch of therapeutic strategy.2
Proportion of circulating tumor DNA (ctDNA) Mutation positive patients
Proportion of ctDNA mutation positive patients at baseline above a predefined a cut-off (copies/ml).
Time frame
At baseline3
CDR21
Circulating DNA ratio at day 21 (CDR21) defined as the ratio of mutation abundance at day 21 relative to baseline of the mutant ctDNA allele with the highest abundance (mutant copies/ml) at baseline.
Time frame
At day 21Other outcomes
1
Progression free survival (PFS)
Defined as the time from registration into the trial (PIC2) until radiologic progression or progression according to GCIG criteria during routine follow-up or or death without progression or clinical deterioration of performance status with associated signs of disease (e.g. bowel obstruction and non-measurable disease).
Time frame
From registration until progression or death or date of LPLV whichever occurs first. Depending on the time point of inclusion into the trial the expected maximum follow-up time for an individual patient might range between 2.5 and 4,6 years.2
PD-L1 expression
Comparing PD-L1 expression between ctDNA responders and non-responders (CDR21 median)
Time frame
At day 21Sponsors and contacts
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Source ClinicalTrials.gov