OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy

NCT06466382 | Recruiting

• 1 other identifier: Swiss-GO-08/ OV Precision
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

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.

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasm Epithelial; 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

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  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.

  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.

  10 weeks

Study Arms (2)

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.

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.

Other: Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling

Interventions

Carboplatin / Paclitaxel Chemotherapy DRUG

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

Also known as: Standard of care chemotherapy regime

Control Arm

Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling OTHER

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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss GO Trial Group: lead
• Tumor Profiler Center Switzerland: collaborator

Study Sites (7)

Kantonsspital Baden AG

Baden, Canton of Aargau, 5404, Switzerland

RECRUITING

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

HOCH Health Ostschweiz Kantonsspital St.Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Thurgau AG Frauenfeld / Münsterlingen

Frauenfeld, Thurgau, 8500, Switzerland

RECRUITING

Inselspital Bern (University Hospital for Medical Oncology)

Bern, 3010, Switzerland

RECRUITING

HFR-Fribourg- Hopital Cantonal

Fribourg, 1708, Switzerland

RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Viola Heinzelmann-Schwarz, Prof.

  University Hospital Basel, Head Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maren S Vogel, PhD

CONTACT

+41 61 3284203; maren.vogel@usb.ch

Team Swiss GO Trial Group

CONTACT

+41 61 3284203; pm-team@swiss-go.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 20, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

CH (7)