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Ovarian CancerPhase 2/3MIMOSANCT00418574

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

A Phase 2/3 study testing Abagovomab in people with Ovarian Cancer, run by Menarini Group at 150 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Abagovomab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
888 participants
Where
150 sitesin 9 countries
Study dates
Dec 2006to Jun 2011
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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:
Show all 18Show fewer
  • 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.

Who cannot join

  • 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);
Show all 19Show fewer
  • 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.

Trial locations and contacts

150 sites in 9 countries.

150 sites in 9 countries

Germany45 sites

  • Helios Kliniken GmbH, Klinikum Buch

    Berlin, 13125

  • Charité - Campus Virchow Klinikum

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, 53125

  • Klinikum Bremen-Mitte gGmbH

    Bremen, 28177

  • Klinikum Chemnitz GmbH

    Chemnitz, 09009

  • St.-Josefs-Hospital Cloppenburg

    Cloppenburg, 49661

  • Klinikum der Universität zu Köln

    Cologne, 50924

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Evangelisches Krankenhaus

    Düsseldorf, 40217

  • Kreisklinik Ebersberg gGmbH

    Ebersberg, 85560

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum

    Essen, 45122

  • Klinikum der JWG Universität Frankfurt

    Frankfurt, 60591

  • Universitätsklinikum

    Freiburg im Breisgau, 79106

  • Universitätsklinikum

    Göttingen, 37075

  • Klinikum der Ernst-Moritz-Universität

    Greifswald, 17487

  • Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät

    Halle, 6120

  • Universitätskrankenhaus Hamburg-Eppendorf

    Hamburg, 20251

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Jena

    Jena, 07743

  • St. Vincentius Kliniken AG

    Karlsruhe, 76137

  • Klinikum Kassel

    Kassel, 32125

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Kreiskrankenhaus Leonberg

    Leonberg, 71229

  • Asklepios Klinik Lich

    Lich, 35423

  • Vincenz-Krankenhaus

    Limburg, 65549

  • Klinik St. Marienstift

    Magdeburg, 39101

  • Städtisches Klinikum Magdeburg

    Magdeburg, 39104

  • Otto-von-Guericke-Universität

    Magdeburg, 39108

  • Johannes-Gutenberg-Universität

    Mainz, 55131

  • Universitätsklinikum Gießen u. Marburg

    Marburg, 35043

  • Klinikum der Universität München-Innenstadt

    München, 80337

  • Klinikum Großhadern

    München, 81377

  • Klinikum rechts der Isar

    München, 81657

  • Klinikum Offenbach GmbH

    Offenbach, 63069

  • St. Vincenz-Krankenhaus Paderborn

    Paderborn, 33098

  • Elblandkliniken Meißen-Radebeul GmbH

    Radebeul, 01445

  • Krankenhaus St. Josef

    Regensburg, 93053

  • Klinikum Südstadt der Hansestadt Rostock

    Rostock, 18059

  • Universitätsklinikum Tübingen

    Tübingen, 72576

  • Universitätsklinikum

    Ulm, 89075

  • Klinikum der Stadt Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78050

  • St. Josefs-Hospital

    Wiesbaden, 65189

  • r. Horst Schmidt Kliniken GmbH

    Wiesbaden, 65199

  • Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg

    Wolfsburg, 38440

Other trials in Germany

United States22 sites

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Colorado

    Denver, Colorado, 80262

  • Wayne State University

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • Hackensack University Medical Center, Obstetrics and Gynecology Oncology

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Pavilion

    Indianapolis, Indiana, 46202

  • Women's Cancer Center

    Las Vegas, Nevada, 89109

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90095-1740

  • The West Clinic

    Memphis, Tennessee, 38120

  • University of Miami

    Miami, Florida, 33136

  • Memorial Sloan-Kettering Cancer Centre

    New York, New York, 10021

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02903

  • Curtis and Elizabeth Anderson Cancer Institute

    Savannah, Georgia, 31404

  • Washington University

    St Louis, Missouri, 63130

  • The Cancer Care Center

    St Louis, Missouri, 63141

  • Stanford University

    Stanford, California, 94305-5317

Other trials in United States

Spain21 sites

  • Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

    A Coruña, 15009

  • Hospital Germans Trias y Pujol

    Badalona, 08916

  • Hospital Vall d'Hebrón, Servicio de Oncologia

    Barcelona, 8035

  • Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

    Barcelona, 8036

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital de Elche, Servico de Oncologia

    Elche, 3203

  • Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica

    Girona, 17007

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital Juan Ramón Jiménez de Huelva

    Huelva, 21005

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Universitario Arnau de Vilanova, Servicio de Oncologia

    Lleida, 25198

  • MD Anderson Internacional Espana

    Madrid, 28033

  • Hospital Clinico San Carlos, Servicio de Oncología Medica

    Madrid, 28040

  • Hospital Clinico de Malaga. Servicio de Oncologia

    Málaga, 29010

  • Hospital de Mataró

    Mataró, 08304

  • Hospital Central de Asturias

    Oviedo, 33006

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital Son Dureta, Servicio de Oncología

    Palma de Mallorca, 7014

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Italy18 sites

  • Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico

    Bari, 70124

  • Ospedale S. Orsola Malpighi, Oncologia Medica

    Bologna, 40138

  • Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia

    Campobasso, 86100

  • DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini

    Carpi (MO), 41012

  • Oncologia Medica Ospedale di Faenza - AUSL di Ravenna

    Faenza, 48018

  • Azienda Ospedaliera - Universitaria Careggi

    Florence, 50100

  • Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica

    Genova, 16132

  • Istituto Nazionale dei Tumori di Milano

    Milan, 20133

  • Istituto Europeo di Oncologia - Divisione di Ginecologia

    Milan, 20141

  • Policlinico di Modena, Dipartimento di Oncologia ed Ematologia

    Modena, 41100

  • Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica

    Naples, 80131

  • Azienda Ospedaliera San Carlo - Oncologia Medica

    Potenza, 85100

  • Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica

    Reggio Calabria, 89125

  • Arcispedale Santa Maria Nuova, Oncologia Medica

    Reggio Emilia, 42100

  • Policlinico Umberto I D.H. Oncologico Oncologia Medica

    Roma, 00161

  • Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli

    Roma, 00168

  • Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia

    San Giovanni Rotondo (FG), 71013

  • Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna

    Torino, 10126

Other trials in Italy

Czechia13 sites

  • Fakultni nemocnice Brno

    Brno, 65677

  • MOU Zluty Kopec

    Brno, 65691

  • Nemocnice Ceske Budejovice, a.s.

    České Budějovice, 37087

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke

    Liberec, 46063

  • Fakultni nemocnice Olomouc

    Olomouc, 77520

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

  • Krajska nemocnice

    Pardubice, 53203

  • Gynekologicko-porodnicka klinika FN Plzen

    Pilsen, 32600

  • Fakultni nemocnice Královské Vinohrady

    Prague, 100 34

  • Vseobecna Fakultni Nemocnice

    Prague, 12851

  • Fakultni nemocnice Bulovka

    Prague, 18000

  • Krajska nemocnice T. Bati

    Zlín, 762 75

Other trials in Czechia

Poland13 sites

  • Wojewódzki Szpital Specjalistyczny Nr 4

    Bytom, 41-902

  • Oddzial Onkologii Wojewódzki Szpital Specjalistyczny

    Częstochowa, 42-200

  • Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Gdansk, 80-210

  • Vesalius Kraków

    Krakow, 31-108

  • "Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,

    Krakow, 31-115

  • Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny

    Lodz, 93-509

  • Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

  • Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu

    Poznan, 61-878

  • SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii

    Rybnik, 44-200

  • Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej

    Torun, 87-100

  • Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON

    Warsaw, 00-909

  • Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych

    Warsaw, 02-507

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych

    Warsaw, 02-781

Other trials in Poland

Hungary8 sites

  • Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia

    Budapest, 1032

  • Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika

    Budapest, 1085

  • Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika

    Budapest, 1088

  • Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika

    Debrecen, 4012

  • Petz Aladar Megyei Oktató Kórház, Onkoradiológia

    Győr, 9024

  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika

    Pécs, 7624

  • Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály

    Tatabánya, 2800

Other trials in Hungary

Belgium6 sites

  • Algemeen Stedelijk Ziekenhuis Aalst

    Aalst, 9300

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent Medische Oncologie 4B-Z

    Ghent, 9000

  • CHU de Liége (Sart Tilman)

    Liège, 4000

  • Clinique Sainte Elizabeth

    Namur, 5000

  • AZ Sint Augustinus, Oncologisch Centrum GVA

    Wilrijk, 2610

Other trials in Belgium

France4 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Jean Bernard

    Le Mans, 72015

  • Centre Catherine de Sienne

    Nantes, 44202

  • Hôpital Hotel Dieu

    Paris, 75181

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Abagovomab, Placebo
Keywords
Ovarian cancer, Abagovomab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbagovomabBiological

    2 mg/ml SC (subcutaneously)

  • PlaceboBiological

    2 mg/ml SC (subcutaneously)

Study groups in NCT00418574
Study groupRoleWhat they receive
AbagovomabExperimentalNot described
Receives: Biological: Abagovomab
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 12 weeks up to recurrence or up to 3 months after last administered dose

Secondary outcomes (3)

  1. Overall Survival

    2 years survival rate

    Measured: 2 years

  2. 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.

    Measured: 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

  3. 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).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2010
  4. Study completionJun 2011

Why it stopped: No benefit on primary end point (RFS); no rationale to collect survival data

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
888 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00418574
Sponsor's protocol ID
ABA-01
Other IDs
AGO-OVAR 10, 2006-002801-30
Acronym
MIMOSA
Status last verified
Nov 2011
First submitted
4 Jan 2007
Last updated
24 Nov 2011
Data monitoring committee
Yes

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.

    PubMed 15014007

  • 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.

    PubMed 11350879

  • 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.

    PubMed 17005631

  • 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.

    PubMed 17000686

  • 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.

    PubMed 24952307

  • 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.

    PubMed 23478059

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Abagovomab in people with Ovarian Cancer, run by Menarini Group at 150 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in Germany, United States, Spain, Italy, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) (time frame: Every 12 weeks up to recurrence or up to 3 months after last administered dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00418574, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.

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