Study Stopped
No benefit on primary end point (RFS); no rationale to collect survival data
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
3 other identifiers
interventional
888
9 countries
150
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Dec 2006
Typical duration for phase_2 ovarian-cancer
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2007
CompletedFirst Posted
Study publicly available on registry
January 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
November 18, 2011
CompletedNovember 24, 2011
November 1, 2011
4 years
January 4, 2007
July 1, 2011
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Every 12 weeks up to recurrence or up to 3 months after last administered dose
Secondary Outcomes (3)
Overall Survival
2 years
Safety
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
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)
Study Arms (2)
Abagovomab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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);
- +2 more criteria
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Menarini Grouplead
Study Sites (150)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095-1740, United States
Stanford University
Stanford, California, 94305-5317, United States
University of Colorado
Denver, Colorado, 80262, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
University of Miami
Miami, Florida, 33136, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Curtis and Elizabeth Anderson Cancer Institute
Savannah, Georgia, 31404, United States
Indiana University Cancer Pavilion
Indianapolis, Indiana, 46202, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University
Detroit, Michigan, 48202, United States
Washington University
St Louis, Missouri, 63130, United States
The Cancer Care Center
St Louis, Missouri, 63141, United States
Women's Cancer Center
Las Vegas, Nevada, 89109, United States
Hackensack University Medical Center, Obstetrics and Gynecology Oncology
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan-Kettering Cancer Centre
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02903, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, 9300, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent Medische Oncologie 4B-Z
Ghent, 9000, Belgium
CHU de Liége (Sart Tilman)
Liège, 4000, Belgium
Clinique Sainte Elizabeth
Namur, 5000, Belgium
AZ Sint Augustinus, Oncologisch Centrum GVA
Wilrijk, 2610, Belgium
Fakultni nemocnice Brno
Brno, 65677, Czechia
MOU Zluty Kopec
Brno, 65691, Czechia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 37087, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke
Liberec, 46063, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77520, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52, Czechia
Krajska nemocnice
Pardubice, 53203, Czechia
Gynekologicko-porodnicka klinika FN Plzen
Pilsen, 32600, Czechia
Fakultni nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice
Prague, 12851, Czechia
Fakultni nemocnice Bulovka
Prague, 18000, Czechia
Krajska nemocnice T. Bati
Zlín, 762 75, Czechia
Institut Bergonié
Bordeaux, 33076, France
Centre Jean Bernard
Le Mans, 72015, France
Centre Catherine de Sienne
Nantes, 44202, France
Hôpital Hotel Dieu
Paris, 75181, France
Helios Kliniken GmbH, Klinikum Buch
Berlin, 13125, Germany
Charité - Campus Virchow Klinikum
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53125, Germany
Klinikum Bremen-Mitte gGmbH
Bremen, 28177, Germany
Klinikum Chemnitz GmbH
Chemnitz, 09009, Germany
St.-Josefs-Hospital Cloppenburg
Cloppenburg, 49661, Germany
Klinikum der Universität zu Köln
Cologne, 50924, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Evangelisches Krankenhaus
Düsseldorf, 40217, Germany
Kreisklinik Ebersberg gGmbH
Ebersberg, 85560, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum
Essen, 45122, Germany
Klinikum der JWG Universität Frankfurt
Frankfurt, 60591, Germany
Universitätsklinikum
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum
Göttingen, 37075, Germany
Klinikum der Ernst-Moritz-Universität
Greifswald, 17487, Germany
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät
Halle, 6120, Germany
Universitätskrankenhaus Hamburg-Eppendorf
Hamburg, 20251, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Jena
Jena, 07743, Germany
St. Vincentius Kliniken AG
Karlsruhe, 76137, Germany
Klinikum Kassel
Kassel, 32125, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105, Germany
Kreiskrankenhaus Leonberg
Leonberg, 71229, Germany
Asklepios Klinik Lich
Lich, 35423, Germany
Vincenz-Krankenhaus
Limburg, 65549, Germany
Klinik St. Marienstift
Magdeburg, 39101, Germany
Städtisches Klinikum Magdeburg
Magdeburg, 39104, Germany
Otto-von-Guericke-Universität
Magdeburg, 39108, Germany
Johannes-Gutenberg-Universität
Mainz, 55131, Germany
Universitätsklinikum Gießen u. Marburg
Marburg, 35043, Germany
Klinikum der Universität München-Innenstadt
München, 80337, Germany
Klinikum Großhadern
München, 81377, Germany
Klinikum rechts der Isar
München, 81657, Germany
Klinikum Offenbach GmbH
Offenbach, 63069, Germany
St. Vincenz-Krankenhaus Paderborn
Paderborn, 33098, Germany
Elblandkliniken Meißen-Radebeul GmbH
Radebeul, 01445, Germany
Krankenhaus St. Josef
Regensburg, 93053, Germany
Klinikum Südstadt der Hansestadt Rostock
Rostock, 18059, Germany
Universitätsklinikum Tübingen
Tübingen, 72576, Germany
Universitätsklinikum
Ulm, 89075, Germany
Klinikum der Stadt Villingen-Schwenningen GmbH
Villingen-Schwenningen, 78050, Germany
St. Josefs-Hospital
Wiesbaden, 65189, Germany
r. Horst Schmidt Kliniken GmbH
Wiesbaden, 65199, Germany
Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg
Wolfsburg, 38440, Germany
Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia
Budapest, 1032, Hungary
Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika
Budapest, 1085, Hungary
Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika
Budapest, 1088, Hungary
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika
Debrecen, 4012, Hungary
Petz Aladar Megyei Oktató Kórház, Onkoradiológia
Győr, 9024, Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika
Pécs, 7624, Hungary
Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály
Tatabánya, 2800, Hungary
Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico
Bari, 70124, Italy
Ospedale S. Orsola Malpighi, Oncologia Medica
Bologna, 40138, Italy
Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia
Campobasso, 86100, Italy
DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini
Carpi (MO), 41012, Italy
Oncologia Medica Ospedale di Faenza - AUSL di Ravenna
Faenza, 48018, Italy
Azienda Ospedaliera - Universitaria Careggi
Florence, 50100, Italy
Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica
Genova, 16132, Italy
Istituto Nazionale dei Tumori di Milano
Milan, 20133, Italy
Istituto Europeo di Oncologia - Divisione di Ginecologia
Milan, 20141, Italy
Policlinico di Modena, Dipartimento di Oncologia ed Ematologia
Modena, 41100, Italy
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
Napoli, 80131, Italy
Azienda Ospedaliera San Carlo - Oncologia Medica
Potenza, 85100, Italy
Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica
Reggio Calabria, 89125, Italy
Arcispedale Santa Maria Nuova, Oncologia Medica
Reggio Emilia, 42100, Italy
Policlinico Umberto I D.H. Oncologico Oncologia Medica
Roma, 00161, Italy
Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli
Roma, 00168, Italy
Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia
San Giovanni Rotondo (FG), 71013, Italy
Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna
Torino, 10126, Italy
Wojewódzki Szpital Specjalistyczny Nr 4
Bytom, 41-902, Poland
Oddzial Onkologii Wojewódzki Szpital Specjalistyczny
Częstochowa, 42-200, Poland
Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Gdansk, 80-210, Poland
Vesalius Kraków
Krakow, 31-108, Poland
"Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,
Krakow, 31-115, Poland
Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny
Lodz, 93-509, Poland
Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, 10-228, Poland
Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu
Poznan, 61-878, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii
Rybnik, 44-200, Poland
Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej
Torun, 87-100, Poland
Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON
Warsaw, 00-909, Poland
Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych
Warsaw, 02-507, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych
Warsaw, 02-781, Poland
Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica
A Coruña, 15009, Spain
Hospital Germans Trias y Pujol
Badalona, 08916, Spain
Hospital Vall d'Hebrón, Servicio de Oncologia
Barcelona, 8035, Spain
Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
Barcelona, 8036, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital de Elche, Servico de Oncologia
Elche, 3203, Spain
Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica
Girona, 17007, Spain
Hospital Virgen de las Nieves
Granada, 18014, Spain
Hospital Juan Ramón Jiménez de Huelva
Huelva, 21005, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
Lleida, 25198, Spain
MD Anderson Internacional Espana
Madrid, 28033, Spain
Hospital Clinico San Carlos, Servicio de Oncología Medica
Madrid, 28040, Spain
Hospital de Mataró
Mataró, 08304, Spain
Hospital Clinico de Malaga. Servicio de Oncologia
Málaga, 29010, Spain
Hospital Central de Asturias
Oviedo, 33006, Spain
Hospital Son Llatzer
Palma de Mallorca, 07198, Spain
Hospital Son Dureta, Servicio de Oncología
Palma de Mallorca, 7014, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Related Publications (6)
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.
PMID: 15014007BACKGROUNDWagner 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.
PMID: 11350879BACKGROUNDPfisterer 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.
PMID: 17005631BACKGROUNDSabbatini 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.
PMID: 17000686BACKGROUNDBuzzonetti 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.
PMID: 24952307DERIVEDSabbatini 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.
PMID: 23478059DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Director
- Organization
- Menarini Ricerche SpA
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2007
First Posted
January 5, 2007
Study Start
December 1, 2006
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
November 24, 2011
Results First Posted
November 18, 2011
Record last verified: 2011-11