Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients

NCT04227522 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: NOGGO ov42
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 17

Brief Summary

MAMOC is a multicenter, randomized, placebo controlled, double blind study including BRCA negative patients with histologically confirmed, advanced (FIGO stage IIIA, IIIB, IIIC, or IV of the 2014 FIGO classification) high grade serous or high grade endometrioid (based on local histopathological findings) ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary in first line therapy.

Conditions

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

Keywords

Rucaparib; maintenance therapy; Bevacizumab; Ovarian Cancer; BRCA negative

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  time from randomization until disease progression or death

  48 months

Secondary Outcomes (11)

• Progression free survival 2 (PFS2)

  48 months

• Quality of Life (QoL) 1

  48 months

• Quality of Life 2

  48 months

• Quality of Life/ Global health status 3

  48 months

• Quality of Life 4

  48 months

Study Arms (2)

Arm A (Rucaparib)

EXPERIMENTAL

Rucaparib treatment (starting dose 600 mg, twice daily) after receiving Bevacizumab for 12 to 15 months. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

Drug: Rucaparib

Arm B (Placebo)

PLACEBO COMPARATOR

Placebo treatment after receiving Bevacizumab for 12 to 15 months. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

Drug: Placebos

Interventions

Rucaparib DRUG

A starting dose of 600 mg Rucaparib is taken twice daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.

Arm A (Rucaparib)

Placebos DRUG

Placebo is taken daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.

Arm B (Placebo)

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.
• Age ≥ 18.
• Patients with histologically confirmed, advanced (FIGO stage IIIA, IIIB, IIIC, or IV of the 2014 FIGO classification) high grade serous or high grade endometrioid (based on local histopathological findings) ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary in first line therapy.
• Availability of archival tumor tissue for central next-generation sequencing (NGS) Analysis and no Detection BRCA mutation (BRCAnegative).
• Treatment with Bevacizumab or respective biosimilar for 12 to 15 months, independent of dosage.
• Patients who have completed first line platinum-taxane chemotherapy and at least stable disease after treatment with Bevacizumab before randomization.
• Patients must be randomized at least 3 weeks and no more than 9 weeks after their last dose of Bevacizumab (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTCAE grade 1 or better (except alopecia and peripheral neuropathy).
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• 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)) ≤3 x ULN, unless liver metastases are present in which case they must be ≤ 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 low grade serous ovarian cancer, or low grade endometrioid ovarian cancer, or mucinous carcinoma.
• Patients with myelodysplastic syndrome/acute myeloid leukemia history.
• Patients receiving radiotherapy within 6 weeks prior to study treatment.
• Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
• Previous allogeneic bone marrow transplant.
• Use of any other PARP-inhibitor in first line therapy.
• 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).
• Clinically significant (e.g. active) cardiovascular disease.
• Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
• History or evidence of hemorrhagic disorders within 6 months prior to randomization.
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
• History or evidence for brain metastases or spinal cord compression.
• History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
• Significant traumatic injury during 4 weeks prior to randomization.
• Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations.

Sponsors & Collaborators

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

Study Sites (17)

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

ANregiomed Frauenklinik Ansbach

Ansbach, 91522, Germany

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Städtisches Klinikum Dessau

Dessau, 06847, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Kliniken Essen Mitte

Essen, 45136, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken g AG

Karlsruhe, 76135, Germany

Location

Städtisches Krankenhaus Kiel

Kiel, 24116, Germany

Location

ZAGO-Zentrum für ambulante gynäkologische Onkologie

Krefeld, 47805, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

LMU Klinikum Großhadern

München, 81377, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

CaritasKlinikum Saarbrücken

Saarbrücken, 66113, Germany

Location

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, 65199, Germany

Location

Related Publications (1)

• Malhan D, Hesse J, Nelson N, Stankov K, Nguyen J, Aboumanify O, Garmshausen J, Rogmans G, Czogalla B, Gerber J, Koch M, Kupec T, Tome O, Witteler R, Deryal M, Eichbaum M, Sehouli J, Braicu EI, Relogio A. Circadian rhythm disruption by PARP inhibitors correlates with treatment toxicity in patients with ovarian cancer and is a predictor of side effects. EBioMedicine. 2025 Jul;117:105764. doi: 10.1016/j.ebiom.2025.105764. Epub 2025 May 16.

  PMID: 40382284 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Adenocarcinoma, Clear Cell

Interventions

rucaparib

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.

  Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 13, 2020
• Study Start: June 8, 2020
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: after first main publication

Locations

DE (17)