Clinical trial NCT06466382: OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
Official title: OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Neoplasm Epithelial
Fallopian Tube Neoplasms
Ovarian Endometrioid Carcinoma
High-grade Serous Ovarian Carcinoma (HGSOC)
Keywords: Primary ovarian cancer (OC)
Treatment naiive
Multi-modal tumor profiling
Treatment recommendation process
Multi-disciplinary tumor board
Patient benefit
Quality of Life (QoL)
Patient-personalized therapy
Lead sponsor: Swiss GO Trial Group
Sponsor class: NETWORK
Collaborators: name: Tumor Profiler Center Switzerland
First posted: 2024-06-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long-term goal of this research project is to demonstrate whether HRD negative (HPDneg) patients benefit when additional multi-modal biological tumor information is incorporated into the molecular tumor board (mTB) treatment recommendation process.

Detailed description: Homologous recombination proficient (HRP) or HRD negative (HRDneg) Ovarian Cancer (OC) patients have a poor outcome equivalent to platinum-resistant patients (PFS 11.5 month). Given standard of care chemotherapy is not ideal for 50% of EOC and this patient population urgently needs alternative treatment options tailored to their individual tumor profile. Treatment options for the heterogeneous HRDneg patient group are scarce and mainly focus on symptom control and palliation, delaying time to symptomatic progression, and improving QoL.

Therefore, trials at initial diagnosis, when the patient can still be cured and is treatment naïve, are urgently needed.

The intervention studied is a personalized treatment recommendation by a specialized molecular tumorboard. This recommendation is based on a molecular summary report (MSR), which is created by multi-modal Tumor Profiling (TP), i.e., molecular analysis of clinical specimens, obtained from the individual participant.

TP, a technology platform of several precision-cancer profiling domains established by the TPC (= Tumor Profiler Center, Switzerland). It combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care (SOC).

The usability in clinical practice of this recommendation will be tested. It should support the clinical decision of the treating oncologists and patients to choose the best possible therapy for the individual patient. Treatment recommendations on the most appropriate molecular-based treatment for the individual patient are formulated based on the expertise and experience of the mTB board members. Additionally, a MSR from a validated TP technology platform can serve as further guidance in the tumorboard. However, the final decision on initial treatment remains at the discretion of the treating physician and the patient.

OV Precision is a multicenter randomized (1:1) controlled trial comparing a personalized treatment recommendation at the discretion of the treating physician in agreement with the patient versus SOC without receiving a mTB recommendation.

The study will be divided into two phases: an initial diagnostic phase, in which presumed eligible patients will be recruited into the study, HRD status will be determined, and tumor profiling will be performed in HRDneg patients with a confirmed diagnosis. Eligible patients will be randomized and treated according to their group allocation in the second phase (treatment phase).

The study duration is planned for 3 years including analysis: Two years of recruitment (starting from 09/2024), final analysis of the focal endpoints and end of the study 10 weeks after inclusion of the last patient (12/2026). Study analysis and publication should be completed approximately one year later (12/2027).

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed EOC (adenocarcinoma of the ovary, peritoneum, and fallopian tube) and carcinosarcoma patients with a suspected FIGO Stage III and IV
* No immediate need of systemic or surgical treatment at time of and until 2 weeks after diagnosis
* Envisaged surgical candidate for interval debulking after 2 cycles of treatment
* Willing and able to attend the visits, to understand the purpose of the trial and all trial-related procedures
* ECOG 0-2
* Written informed consent according to national legal and regulatory requirements prior to any project specific procedures

Exclusion Criteria:

* Elevated liver enzymes (double of normal range: ASAT \> 68 U/l; ALAT \> 82 U/l; GGT \> 80 U/l)
* Elevated creatinine (double of normal range: \>120 mmol/l))
* ECOG ≥3
* Pregnant or lactating women
* Any other malignancy within the last 5 years which has an impact on the prognosis of the patient
* Inability to swallow tablets
* Concurrent participation in another clinical trial on the same indication
* Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the sponsor-project leader may interfere with the project or affect patient compliance

Primary outcomes:
measure: Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option
timeFrame: 2-3 weeks
measure: FOM 2 of pilot study: Investigation whether the treating oncologist feels better supported by the mTB recommendation considers the additional biological tumor information than by the standard of care where such information is not considered.
timeFrame: 2-3 weeks
measure: FOM 3 of pilot study: Investigation of different treatment decisions by the patient and the treating oncologist.
timeFrame: 4 weeks
measure: FOM 4 of pilot study: Preliminary estimate of the actual patient benefit of the intervention in terms of a number of patient-relevant outcomes.
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG
state: Aargau
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel Stadt
city: St Gallen
country: Switzerland
facility: HOCH Health Ostschweiz Kantonsspital St.Gallen
state: Saint Gallen
city: Frauenfeld
country: Switzerland
facility: Thurgau AG Frauenfeld / Münsterlingen
state: Thurgau
Study officials:
affiliation: University Hospital Basel, Head Women's Hospital
name: Viola Heinzelmann-Schwarz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: