A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

NCT05460000 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NOGGO-ov53
• Study Type: interventional
• Target: 640
• Locations: 6 countries
• Sites: 47

Brief Summary

Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.

Conditions

Clear Cell Carcinoma; Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

maintenance therapy; niraparib; HRDpositive; R0; primary tumor debulking; chemotherapy; LOH; carboplatin; paclitaxel; first line

Outcome Measures

Primary Outcomes (1)

• RFS

  Recurrence free survival, defined as time from treatment randomization to the earliest date of assessment of first relapse or death by any cause

  8 years

Secondary Outcomes (9)

• Overall survival (OS)

  8 years

• TFST

  8 years

• TWIST (Time Without Symptoms of disease progression or Toxicity of treatment)

  8 years

• PFS2

  8 years

• Quality of Life (QoL) 1

  8 years

Study Arms (2)

Arm A (3 cycles of chemotherapy + maintenance therapy with niraparib)

EXPERIMENTAL

3 cycles carboplatin + paclitaxel maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

Drug: 3 cycles chemotherapy instead of 6 cycles chemotherapy

Arm B (6 cycles of chemotherapy + maintenance therapy with niraparib)

ACTIVE COMPARATOR

6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

Drug: 6 cycles chemotherapy

Interventions

3 cycles chemotherapy instead of 6 cycles chemotherapy DRUG

We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.

Arm A (3 cycles of chemotherapy + maintenance therapy with niraparib)

6 cycles chemotherapy DRUG

Standard chemotherapy as comparator

Arm B (6 cycles of chemotherapy + maintenance therapy with niraparib)

Eligibility Criteria

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

You may qualify if:

• Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• Female patient, age ≥ 18 years.
• FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)
• Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.
• Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score \>83 independent of BRCA status, based on these results.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients must be able to take oral medications.
• Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial.
• Patients must have normal organ and bone marrow function:
• Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
• Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2,5 x ULN
• Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \> 30 mL/min.

You may not qualify if:

• Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary.
• Low-grade ovarian, fallopian tube or peritoneal cancer.
• Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.
• Has known hypersensitivity to platin-containing compounds other than carboplatin.
• Patients posttransplant, including previous allogeneic bone marrow transplant.
• Has undergone interval debulking of the tumor.
• Has received any anti-cancer therapy for ovarian cancer other than primary surgery.
• Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
• Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor.
• Bevacizumab is planned to be given together with first line chemotherapy or as maintenance.
• Clinically significant cardiovascular disease:
• Cerebrovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment
• Severe cardiac arrhythmia (recent event or active or uncontrolled)
• New York Heart Association grade ≥2 congestive heart failure
• Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy or posterior reversible encephalopathy syndrome

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: lead
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: collaborator

Study Sites (47)

Universitätsklinik Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Cliniques Universitaires St. Luc

Brussels, Belgium

ACTIVE NOT RECRUITING

UZ Gent

Ghent, Belgium

NOT YET RECRUITING

Jessa ziekenhuis

Hasselt, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, Belgium

ACTIVE NOT RECRUITING

University Hospital Ostrava

Ostrava, Czechia

ACTIVE NOT RECRUITING

General University Hospital in Prague

Prague, Czechia

RECRUITING

University Hospital Bulovka

Prague, Czechia

ACTIVE NOT RECRUITING

Universitätsklinikum Aachen

Aachen, 52074, Germany

RECRUITING

Klinikum Mittelbaden Baden-Baden Bühl

Baden-Baden, Germany

NOT YET RECRUITING

DRK-Kliniken Berlin-Köpenick

Berlin, 12559, Germany

RECRUITING

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

RECRUITING

ZAHO Bonn Onkologische Praxis

Bonn, 53115, Germany

ACTIVE NOT RECRUITING

Uniklinikum Bonn

Bonn, Germany

ACTIVE NOT RECRUITING

Klinikum Lippe

Detmold, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

ACTIVE NOT RECRUITING

Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth

Düsseldorf, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

ACTIVE NOT RECRUITING

Universitätsklinik Göttingen

Göttingen, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

ACTIVE NOT RECRUITING

SLK-Kliniken Heilbronn

Heilbronn, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Leipzig

Leipzig, Germany

ACTIVE NOT RECRUITING

Universitätsklinik der Johannes-Gutenberg Universität Mainz

Mainz, 55131, Germany

ACTIVE NOT RECRUITING

Diakonie Klinikum Schwäbisch Hall

Schwäbisch Hall, Germany

RECRUITING

Christliches Klinikum Unna Mitte

Unna, 59423, Germany

ACTIVE NOT RECRUITING

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, 65199, Germany

RECRUITING

Policlinico St. Orsola Malpighi

Bologna, Italy

ACTIVE NOT RECRUITING

ASST Spedali Civili di Brescia

Brescia, Italy

ACTIVE NOT RECRUITING

ASST Lecco - Ospedale A. Manzoni

Lecco, Italy

NOT YET RECRUITING

IRCCS Istituto nazionale dei Tumori

Milan, Italy

NOT YET RECRUITING

AOU Cagliari

Monserrato, Italy

NOT YET RECRUITING

Istituto Oncologico Veneto (IOV)

Padua, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

ACTIVE NOT RECRUITING

Azienda USL IRCCS Di Reggio Emilia

Reggio Emilia, Italy

ACTIVE NOT RECRUITING

AO Ordine Mauriziano

Torino, Italy

ACTIVE NOT RECRUITING

AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

Torino, Italy

NOT YET RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, Spain

ACTIVE NOT RECRUITING

Hospital Virgen de las Nieves

Granada, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Spain

ACTIVE NOT RECRUITING

CIOCC Clara Campal

Madrid, Spain

ACTIVE NOT RECRUITING

H. Althaia Manresa

Manresa, Spain

ACTIVE NOT RECRUITING

H.U. Virgen de la Macarena

Seville, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Sant Joan de Reus

Tarragona, Spain

ACTIVE NOT RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital La Fe

Valencia, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Adenocarcinoma, Clear Cell

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jalid Sehouli, Prof. Dr. med.

  Lead coordinating investigator (LKP) according to AMG and representative of the sponsor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Nguyen

CONTACT

4930403686539; jessica.nguyen@noggo.de

Jasmin Yamamoto

CONTACT

4930403686532; jasmin.yamamoto@noggo.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 15, 2022
• Study Start: October 11, 2024
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (10); AU (1); CZ (3); IT (10); DE (19); BE (4)