Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients (MIMOSA)

A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Biological: Abagovomab; Biological: Placebo

Detailed Description

Standard initial treatment of ovarian cancer patients includes both surgery and chemotherapy which in the vast majority of cases achieves the disappearance of ovarian cancer lesions. This status, called "clinical remission" which means having no evidence of cancer on CT scan or physical examination needs to be carefully follow up in order to confirm the maintenance of the remission status or to early detect if the cancer grows again and then start a new chemotherapy. At present, no approved therapies exist for the maintenance treatment of patients who achieved the clinical remission.

This trial aims to evaluate if the repeated vaccination with Abagovomab creates an immunoresponse which is able to fight the cancer cells thus keeping the remission status as long as possible and help patients live disease-free and longer.

Patients who achieve the remission status after chemotherapy will be screened for study participation and if they meet the criteria for inclusion they will start to receive a single subcutaneous injection every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase). The duration of treatment is up to approximately 4 years or it will be stopped in case relapse occurs.

In order to evaluate the real benefit of vaccination, the experimental treatment includes Abagovomab (the active drug) or placebo (the vehicle only, without drug), with a double chance to receive Abagovomab. Assignment of Abagovomab or placebo will be done by a computerised system and nobody in the study will know which treatment has been allocated until study end.

Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every 12 weeks in order to confirm the remission status or to early detect if relapse eventually occurs. This will be done in blind condition (i.e. without being aware which treatment the patient is going to receive) for the first part of the study which is expected to last four years. After then the overall status of patient will continue to be monitored by phone contact for additional five years.

• Study Type: Interventional
• Enrollment (Actual): 888
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Algemeen Stedelijk Ziekenhuis Aalst
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent Medische Oncologie 4B-Z
  • Liège, Belgium, 4000
    • CHU de Liége (Sart Tilman)
  • Namur, Belgium, 5000
    • Clinique Sainte Elizabeth
  • Wilrijk, Belgium, 2610
    • AZ Sint Augustinus, Oncologisch Centrum GVA
• Czech Republic
  • Brno, Czech Republic, 65677
    • Fakultni Nemocnice Brno
  • Brno, Czech Republic, 65691
    • MOU Zluty Kopec
  • Ceske Budejovice, Czech Republic, 37087
    • Nemocnice Ceske Budejovice, a.s.
  • Hradec Králové, Czech Republic, 50005
    • Fakultni nemocnice Hradec Kralove
  • Liberec, Czech Republic, 46063
    • Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke
  • Olomouc, Czech Republic, 77520
    • Fakultni Nemocnice Olomouc
  • Ostrava, Czech Republic, 708 52
    • Fakultni Nemocnice Ostrava
  • Pardubice, Czech Republic, 53203
    • Krajska nemocnice
  • Plzen, Czech Republic, 32600
    • Gynekologicko-porodnicka klinika FN Plzen
  • Praha, Czech Republic, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 2, Czech Republic, 12851
    • Vseobecna Fakultní Nemocnice
  • Praha 8, Czech Republic, 18000
    • Fakultni nemocnice Bulovka
  • Zlin, Czech Republic, 762 75
    • Krajska nemocnice T. Bati
• France
  • Bordeaux Cedex, France, 33076
    • Institut Bergonié
  • Le Mans Cedex, France, 72015
    • Centre Jean Bernard
  • Nantes Cedex, France, 44202
    • Centre Catherine de Sienne
  • Paris, France, 75181
    • Hôpital Hotel Dieu
• Germany
  • Berlin, Germany, 13125
    • Helios Kliniken GmbH, Klinikum Buch
  • Berlin, Germany, 13353
    • Charité - Campus Virchow Klinikum
  • Bonn, Germany, 53125
    • Universitatsklinikum Bonn
  • Bremen, Germany, 28177
    • Klinikum Bremen-Mitte gGmbH
  • Chemnitz, Germany, 09009
    • Klinikum Chemnitz GmbH
  • Cloppenburg, Germany, 49661
    • St.-Josefs-Hospital Cloppenburg
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus Dresden
  • Düsseldorf, Germany, 40217
    • Evangelisches Krankenhaus
  • Ebersberg, Germany, 85560
    • Kreisklinik Ebersberg gGmbH
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Essen, Germany, 45122
    • Universitätsklinikum
  • Frankfurt, Germany, 60591
    • Klinikum der JWG Universität Frankfurt
  • Freiburg, Germany, 79106
    • Universitätsklinikum
  • Greifswald, Germany, 17487
    • Klinikum der Ernst-Moritz-Universität
  • Göttingen, Germany, 37075
    • Universitätsklinikum
  • Halle/Saale, Germany, 6120
    • Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät
  • Hamburg, Germany, 20251
    • Universitatskrankenhaus Hamburg-Eppendorf
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Jena, Germany, 07743
    • Universitatsklinikum Jena
  • Karlsruhe, Germany, 76137
    • St. Vincentius Kliniken AG
  • Kassel, Germany, 32125
    • Klinikum Kassel
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Köln, Germany, 50924
    • Klinikum der Universität zu Köln
  • Leonberg, Germany, 71229
    • Kreiskrankenhaus Leonberg
  • Lich, Germany, 35423
    • Asklepios Klinik Lich
  • Limburg, Germany, 65549
    • Vincenz-Krankenhaus
  • Magdeburg, Germany, 39101
    • Klinik St. Marienstift
  • Magdeburg, Germany, 39104
    • Städtisches Klinikum Magdeburg
  • Magdeburg, Germany, 39108
    • Otto-von-Guericke-Universität
  • Mainz, Germany, 55131
    • Johannes-Gutenberg-Universität
  • Marburg, Germany, 35043
    • Universitätsklinikum Gießen u. Marburg
  • München, Germany, 81377
    • Klinikum Großhadern
  • München, Germany, 80337
    • Klinikum der Universität München-Innenstadt
  • München, Germany, 81657
    • Klinikum rechts der Isar
  • Offenbach, Germany, 63069
    • Klinikum Offenbach GmbH
  • Paderborn, Germany, 33098
    • St. Vincenz-Krankenhaus Paderborn
  • Radebeul, Germany, 01445
    • Elblandkliniken Meißen-Radebeul GmbH
  • Regensburg, Germany, 93053
    • Krankenhaus St. Josef
  • Rostock, Germany, 18059
    • Klinikum Südstadt der Hansestadt Rostock
  • Tübingen, Germany, 72576
    • Universitatsklinikum Tubingen
  • Ulm, Germany, 89075
    • Universitätsklinikum
  • Villingen-Schwenningen, Germany, 78050
    • Klinikum der Stadt Villingen-Schwenningen GmbH
  • Wiesbaden, Germany, 65189
    • St. Josefs-Hospital
  • Wiesbaden, Germany, 65199
    • r. Horst Schmidt Kliniken GmbH
  • Wolfsburg, Germany, 38440
    • Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg
• Hungary
  • Budapest, Hungary, 1032
    • Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika
  • Debrecen, Hungary, 4012
    • Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika
  • Győr, Hungary, 9024
    • Petz Aladar Megyei Oktató Kórház, Onkoradiológia
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály
  • Pécs, Hungary, 7624
    • Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika
  • Tatabanya, Hungary, 2800
    • Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály
• Italy
  • Bari, Italy, 70124
    • Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico
  • Bologna, Italy, 40138
    • Ospedale S. Orsola Malpighi, Oncologia Medica
  • Campobasso, Italy, 86100
    • Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia
  • Carpi (MO), Italy, 41012
    • DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini
  • Faenza, Italy, 48018
    • Oncologia Medica Ospedale di Faenza - AUSL di Ravenna
  • Firenze, Italy, 50100
    • Azienda Ospedaliera - Universitaria Careggi
  • Genova, Italy, 16132
    • Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica
  • Milano, Italy, 20133
    • Istituto Nazionale dei Tumori di Milano
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia - Divisione di Ginecologia
  • Modena, Italy, 41100
    • Policlinico di Modena, Dipartimento di Oncologia ed Ematologia
  • Napoli, Italy, 80131
    • Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
  • Potenza, Italy, 85100
    • Azienda Ospedaliera San Carlo - Oncologia Medica
  • Reggio Emilia, Italy, 42100
    • Arcispedale Santa Maria Nuova, Oncologia Medica
  • Reggio di Calabria, Italy, 89125
    • Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica
  • Roma, Italy, 00161
    • Policlinico Umberto I D.H. Oncologico Oncologia Medica
  • Roma, Italy, 00168
    • Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli
  • San Giovanni Rotondo (FG), Italy, 71013
    • Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia
  • Torino, Italy, 10126
    • Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna
• Poland
  • Bytom, Poland, 41-902
    • Wojewódzki Szpital Specjalistyczny nr 4
  • Czestochowa, Poland, 42-200
    • Oddzial Onkologii Wojewódzki Szpital Specjalistyczny
  • Gdansk, Poland, 80-210
    • Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Krakow, Poland, 31-108
    • Vesalius Kraków
  • Krakow, Poland, 31-115
    • "Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,
  • Lodz, Poland, 93-509
    • Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny
  • Olsztyn, Poland, 10-228
    • Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Poznan, Poland, 61-878
    • Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej
  • Warszawa, Poland, 00-909
    • Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych
  • Warszawa, Poland, 02-781
    • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych
• Spain
  • Badalona, Spain, 08916
    • Hospital Germans Trias y Pujol
  • Barcelona, Spain, 8035
    • Hospital Vall d'Hebrón, Servicio de Oncologia
  • Barcelona, Spain, 8036
    • Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
  • Córdoba, Spain, 14004
    • Hospital Reina Sofia
  • Elche, Spain, 3203
    • Hospital de Elche, Servico de Oncologia
  • Girona, Spain, 17007
    • Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves
  • Huelva, Spain, 21005
    • Hospital Juan Ramón Jiménez de Huelva
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaén
  • La Coruna, Spain, 15009
    • Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica
  • Lerida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
  • Madrid, Spain, 28033
    • MD Anderson Internacional España
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos, Servicio de Oncología Médica
  • Mataró, Spain, 08304
    • Hospital de Mataro
  • Málaga, Spain, 29010
    • Hospital Clinico de Malaga. Servicio de Oncologia
  • Oviedo, Spain, 33006
    • Hospital Central de Asturias
  • Palma de Mallorca, Spain, 07198
    • Hospital Son Llatzer
  • Palma de Mallorca, Spain, 7014
    • Hospital Son Dureta, Servicio de Oncología
  • Santiago de Compostela, Spain, 15706
    • Hospital Clinico Universitario de Santiago de Compostela
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095-1740
      • University of California, Los Angeles (UCLA)
    • Stanford, California, United States, 94305-5317
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80262
      • University of Colorado
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Curtis and Elizabeth Anderson Cancer Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Cancer Pavilion
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Harry and Jeanette Weinberg Cancer Institute at Franklin Square
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University
    • Saint Louis, Missouri, United States, 63141
      • The Cancer Care Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Women's Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center, Obstetrics and Gynecology Oncology
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Centre
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Women and Infants Hospital of Rhode Island
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • The West Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria:

• Age >/= 18 years;
• Properly executed written informed consent;
• History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer;
• History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy;
• Complete clinical response defined as:
• Normal physical examination;
• No symptoms suggestive of persistent cancer;
• No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks;
• Negative chest x-ray (or chest CT scan) within the previous 4 weeks;
• Serum CA125 within the normal laboratory range.

• Adequate hematologic, renal and hepatic function:

  • Absolute Neutrophil Count (ANC) >/=1.5 * 109/l;
  • Platelets >/= 75 * 109/l;
  • Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl);
  • Serum creatinine </= 1.5 * ULN (Upper Limit of Normal);
  • Bilirubin </= 1.5 * ULN; AST, ALT, AP </= 2.5 * ULN.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) </= 2.

Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are present:

• any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy;
• known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);
• known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);
• known infection with hepatitis B, or hepatitis C;
• history of recent myocardial infarction (</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class >/= III);
• previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy.
• concomitant use of any other investigational agent;
• any prior investigational anti-cancer vaccine or monoclonal antibody;
• known allergy to murine proteins;
• any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures;
• clinically significant active infection;
• concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);
• major surgery within the previous 2 weeks;
• radiotherapy within the previous 4 weeks;
• any significant toxicity from prior chemotherapy;
• unreliability or inability to follow protocol requirements;
• potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period;
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; 2 mg/ml SC (subcutaneously)
Experimental: Abagovomab	Biological: Abagovomab; 2 mg/ml SC (subcutaneously)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)	The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.	Every 12 weeks up to recurrence or up to 3 months after last administered dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	2 years survival rate	2 years
Safety	Safety was analyzed in all patients who received at least 1 dose administration. Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed.	Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose
Time Course of Immunoresponse	Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).	at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)

Collaborators and Investigators

• Sponsor: Menarini Group
• Investigators: Study Chair: Jacobus Pfisterer, MD, AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany; Principal Investigator: Paul Sabbatini, MD, Memorial Sloan-Kettering Cancer Centre- NY; Principal Investigator: Jonathan Berek, MD, COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA; Principal Investigator: Giovanni Scambia, MD, Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy; Principal Investigator: Antonio Casado, MD, Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain; Principal Investigator: Anna Pluzanska, MD, Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland; Principal Investigator: Karel Cwiertka, MD, Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic; Principal Investigator: Tamás Pintér, MD, Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary; Principal Investigator: Eric Pujade-Lauraine, MD, Hôpital Hotel Dieu - Paris, France

Publications and helpful links

General Publications

• Reinartz S, Kohler S, Schlebusch H, Krista K, Giffels P, Renke K, Huober J, Mobus V, Kreienberg R, DuBois A, Sabbatini P, Wagner U. Vaccination of patients with advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival (phase Ib/II). Clin Cancer Res. 2004 Mar 1;10(5):1580-7. doi: 10.1158/1078-0432.ccr-03-0056.
• Wagner U, Kohler S, Reinartz S, Giffels P, Huober J, Renke K, Schlebusch H, Biersack HJ, Mobus V, Kreienberg R, Bauknecht T, Krebs D, Wallwiener D. Immunological consolidation of ovarian carcinoma recurrences with monoclonal anti-idiotype antibody ACA125: immune responses and survival in palliative treatment. See The biology behind: K. A. Foon and M. Bhattacharya-Chatterjee, Are solid tumor anti-idiotype vaccines ready for prime time? Clin. Cancer Res., 7:1112-1115, 2001. Clin Cancer Res. 2001 May;7(5):1154-62.
• Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77. doi: 10.1093/annonc/mdl357.
• Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, Hensley M, Livingston P, Iasonos A, Spriggs D, McGuire W, Reinartz S, Schneider S, Grande C, Lele S, Rodabaugh K, Kepner J, Ferrone S, Odunsi K. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-10. doi: 10.1158/1078-0432.CCR-05-2670.
• Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-45. doi: 10.1007/s00262-014-1569-0. Epub 2014 Jun 21.
• Sabbatini P, Harter P, Scambia G, Sehouli J, Meier W, Wimberger P, Baumann KH, Kurzeder C, Schmalfeldt B, Cibula D, Bidzinski M, Casado A, Martoni A, Colombo N, Holloway RW, Selvaggi L, Li A, del Campo J, Cwiertka K, Pinter T, Vermorken JB, Pujade-Lauraine E, Scartoni S, Bertolotti M, Simonelli C, Capriati A, Maggi CA, Berek JS, Pfisterer J. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study. J Clin Oncol. 2013 Apr 20;31(12):1554-61. doi: 10.1200/JCO.2012.46.4057. Epub 2013 Mar 11.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: January 4, 2007
• First Submitted That Met QC Criteria: January 4, 2007
• First Posted (Estimate): January 5, 2007

Study Record Updates

• Last Update Posted (Estimate): November 24, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Ovarian cancer; Abagovomab
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Antineoplastic Agents; Antineoplastic Agents, Immunological; Abagovomab
• Other Study ID Numbers: ABA-01; AGO-OVAR 10 (Other Identifier: AGO); 2006-002801-30 (EudraCT Number)