Ovarian Neoplasm EpithelialOVPrecisionNCT06466382
OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
A study testing Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling and Carboplatin / Paclitaxel Chemotherapy in people with Ovarian Neoplasm Epithelial and Fallopian Tube Neoplasms, run by Swiss GO Trial Group at 10 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Ovarian Endometrioid Carcinoma
- What is being tested?
- Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling and Carboplatin / Paclitaxel Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 10 sitesSwitzerland
- Study dates
- 31 Mar 2025to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- 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
- Patients have adequate hematology, liver and kidney functions
- 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
Who cannot join
- ECOG ≥3
- Pregnant or lactating women
- Any other malignancy within the last 5 years which has an impact on the prognosis of the patient
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Switzerland10 sites, 10 recruiting
- Not yet recruiting
Kantonsspital Aarau AG
Aarau, 5001
Maximilian Klar, Prof, +41 62 838 57 47, maximilian.klar@ksa.ch
- Recruiting
Kantonsspital Baden AG
Baden, Canton of Aargau, 5404
Martin Heubner, Prof, + 41 56 486 35 02, martin.heubner@ksb.ch
Carina Rofner, +41 56 486 36 32, Carina.Rofner@ksb.ch
- Recruiting
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
Viola Heinzelmann-Schwarz, Prof, +41 61 265 58 83, viola.heinzelmann@usb.ch
Antje Michel, PhD, +41 61 32 84214, antje.michel@usb.ch
- Recruiting
Inselspital Bern (University Hospital for Medical Oncology)
Bern, 3010
Julian Wampfler, +41 31 632 5059, julian.wampfler@insel.ch
Anke Klingenberg-Rettich, +41 31 632 19 28, Anke.Klingenberg-Rettich@insel.ch
- Recruiting
Thurgau AG Frauenfeld / Münsterlingen
Frauenfeld, Thurgau, 8500
Mathias Fehr, Prof, +41 58 144 7255, mathias.fehr@stgag.ch
Daniela Berner, +41 58 144 1729, daniela.berner@stgag.ch
- Recruiting
HFR-Fribourg- Hopital Cantonal
Fribourg, 1708
Vérène Dougoud-Chauvin, Dr. med., +41 26 306.22 60, Verene.Dougoud-Chauvin@h-fr.ch
Mirelle Maître, +41 26 306 22 75, Mireille.Maitre@h-fr.ch
- Recruiting
Hirslanden Klinik St. Anna
Lucerne, 6006
Andreas Günthert, Prof, +41 41 419 03 03, andreas.günthert@gyn-zentrum.ch
Wilma Najera, PhD, wilma.najera@hirslanden.ch
- Recruiting
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Jens Huober, Prof, +41 494 11 11, Jens.Huober@h-och.ch
Julia Kern, +41 71 494 64 52, Julia.Kern@h-och.ch
- Recruiting
Kantonsspital Winterthur
Winterthur, 8401
Teresita Villena Ossa, +41 52 266 27 34, Teresita.villenaossa@ksw.ch
Beatrice Brinkers, beatrice.brinkers@ksw.ch
- Recruiting
University Hospital Zurich
Zurich, 8091
Eleftherios Pierre Samartzis, Dr . med., +41 43 253 09 62, eleftherios.samartzis@usz.ch
Isabel Breyer, PhD, +41 44 255 56 29, isabel.breyer@usz.ch
About this study
Official title: OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer.
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.
Read the 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).
Approximately 135 participants are expected to be enrolled and undergo HRD testing. Of these, approximately 60 participants with HRD-negative tumors are expected to be randomized. Participants with HRD-positive tumors will not be randomized.
The study duration is planned for 3 years including analysis: Two years of recruitment (starting from 03/2025, final analysis of the focal endpoints and end of the study 10 weeks after inclusion of the last patient (06/2027). Study analysis and publication should be completed approximately one year later (06/2028).
- Conditions
- Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Ovarian Endometrioid Carcinoma, High-grade Serous Ovarian Carcinoma (HGSOC)
- Being tested
- Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling, Carboplatin / Paclitaxel Chemotherapy
- 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
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment recommendation by molecular tumorboard (mTB) based on tumor profilingOther
The intervention studied is a treatment recommendation by a specialized molecular tumorboard (mTB). This recommendation is based on an MSR which is created by TP, i.e., molecular analysis of clinical specimens, obtained from the individual participant. TP, a technology platform of several precision-cancer profiling domains, combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care. 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.
Carboplatin / Paclitaxel ChemotherapyDrug
Also called Standard of care chemotherapy regime
2 cycles of chemotherapy with carboplatin AUC5 3-weekly and paclitaxel 175 mg/m2 3-weekly or carboplatin AUC2 weekly and Paclitaxel 60-80mg/m2 weekly
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Physicians and patients randomized to the SOC arm will not receive the treatment recommendation of the mTB and thus will undergo the standard treatment consisting of 2 cycles of chemotherapy with carboplatin AUC5 3-weekly and paclitaxel 175 mg/m2 3-weekly or carboplatin AUC2 weekly and Paclitaxel 60-80mg/m2 weekly.
Either q3w regime or q1w regime. Receives: Drug: Carboplatin / Paclitaxel Chemotherapy |
| Interventional Arm | Experimental | The intervention studied is a treatment recommendation by a specialized molecular tumorboard. This recommendation is based on an MSR which is created by TP, i.e., molecular analysis of clinical specimens, obtained from the individual participant. TP, a technology platform of several precision-cancer profiling domains, combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care. 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. Receives: Other: Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option
- Number (proportion) of cases in which the Tumor Profiling (TP) was able to generate a conclusive Molecular Summary Report (MSR)
- Number (proportion) of cases in which the mTB considers the MSR as useful support for making a treatment recommendation on a scale from zero (not useful at all) to five (very useful)
Measured: 2-3 weeks
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.
- Number (proportion) of cases in which the treating physician considers the mTB recommendation as useful for making a final treatment decision on a scale from zero (not useful at all) to five (very useful).
- Definition of molecular results from TP that cannot be used for clinical decision making.
- Definition of an algorithm for the decision process from MSR to treatment recommendation.
Measured: 2-3 weeks
FOM 3 of pilot study: Investigation of different treatment decisions by the patient and the treating oncologist.
- Number of therapy adaptations in the exploratory arm based on the MSR.
- Number (proportion) of cases with therapy adaptions with minor / major/ no change from SOC.
- Number (proportion) of treatment recommendations by mTB which were followed by the doctor and patient in the window of opportunity.
- Number (proportion) of treatment recommendations by mTB which were continued by the doctor and patient after the trial and after finishing SOC.
- Number (proportion) of treatment recommendations by mTB which were not followed by the doctor and patient in the window of opportunity due to restrictions.
- Differences in hypothetical treatment costs between SOC and exploratory arm.
Measured: 4 weeks
FOM 4 of pilot study: Preliminary estimate of the actual patient benefit of the intervention in terms of a number of patient-relevant outcomes.
The difference in proportions of responders between the standard of care and experimental arm after interval debulking surgery or biopsy at second specimen collection time point (week 10). A patient is classified as a responder if at least one of the two conditions is met: The Chemotherapy Response Score (CRS) is larger than or equal to 2 or the CA125 KELIM score is larger than or equal to 1.
Note A : The three-tired CRS ranges from 1 (no or minimal tumor response) to 3 (total or near-total tumor response) .
Note B: The tumormarker CA125 level decline (= CA125 KELIM ) over at least 3 timepoints can give an indication of therapy response. A favourable KELIM score ≥ 1.0, Unfavorable KELIM score < 1.
- Symptoms measured by MOST- S26 questionnaire from V1 (baseline at diagnosis) until V9 (EOT), in both arms.
- Quality of Life (QoL): Questionnaires EORTC QLQ-C30, EORTC QLQ-OV28 from V1 (baseline at diagnosis) until V9 (EOT), in both arms.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start31 Mar 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Neoplasm EpithelialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss GO Trial Group
- Sponsor type
- Research network
- Collaborators
- Tumor Profiler Center Switzerland
- Responsible party
- Sponsor
- Investigators
- Viola Heinzelmann-Schwarz, Prof., Principal investigator, University Hospital Basel, Head Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466382
- Sponsor's protocol ID
- Swiss-GO-08/ OV Precision
- Acronym
- OVPrecision
- Status last verified
- Oct 2026
- First submitted
- 21 May 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this article, as well as data dictionaries and the study protocol, may be made available upon reasonable request and subject to applicable approvals. Data may be used for individual participant data meta-analyses and other scientifically sound research purposes.