Clinical trial NCT00418574: Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Abagovomab
Lead sponsor: Menarini Group
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 888
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)
timeFrame: Every 12 weeks up to recurrence or up to 3 months after last administered dose
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Safety
timeFrame: 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
measure: Time Course of Immunoresponse
timeFrame: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Savannah
country: United States
facility: Curtis and Elizabeth Anderson Cancer Institute
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Cancer Pavilion
state: Indiana
city: Baltimore
country: United States
facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: The Cancer Care Center
state: Missouri
city: Las Vegas
country: United States
facility: Women's Cancer Center
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center, Obstetrics and Gynecology Oncology
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Centre
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis Aalst
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent Medische Oncologie 4B-Z
city: Liège
country: Belgium
facility: CHU de Liége (Sart Tilman)
city: Namur
country: Belgium
facility: Clinique Sainte Elizabeth
city: Wilrijk
country: Belgium
facility: AZ Sint Augustinus, Oncologisch Centrum GVA
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Brno
country: Czech Republic
facility: MOU Zluty Kopec
city: Ceske Budejovice
country: Czech Republic
facility: Nemocnice Ceske Budejovice, a.s.
city: Hradec Králové
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove
city: Liberec
country: Czech Republic
facility: Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czech Republic
facility: Fakultni Nemocnice Ostrava
city: Pardubice
country: Czech Republic
facility: Krajska nemocnice
city: Plzen
country: Czech Republic
facility: Gynekologicko-porodnicka klinika FN Plzen
city: Praha 2
country: Czech Republic
facility: Vseobecna Fakultni Nemocnice
city: Praha 8
country: Czech Republic
facility: Fakultni nemocnice Bulovka
city: Praha
country: Czech Republic
facility: Fakultni nemocnice Královské Vinohrady
city: Zlin
country: Czech Republic
facility: Krajska nemocnice T. Bati
city: Bordeaux Cedex
country: France
facility: Institut Bergonié
city: Le Mans Cedex
country: France
facility: Centre Jean Bernard
city: Nantes Cedex
country: France
facility: Centre Catherine de Sienne
city: Paris
country: France
facility: Hôpital Hotel Dieu
city: Berlin
country: Germany
facility: Helios Kliniken GmbH, Klinikum Buch
city: Berlin
country: Germany
facility: Charité - Campus Virchow Klinikum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz GmbH
city: Cloppenburg
country: Germany
facility: St.-Josefs-Hospital Cloppenburg
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg gGmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum
city: Frankfurt
country: Germany
facility: Klinikum der JWG Universität Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum
city: Greifswald
country: Germany
facility: Klinikum der Ernst-Moritz-Universität
city: Göttingen
country: Germany
facility: Universitätsklinikum
city: Halle/Saale
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken AG
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Köln
country: Germany
facility: Klinikum der Universität zu Köln
city: Leonberg
country: Germany
facility: Kreiskrankenhaus Leonberg
city: Lich
country: Germany
facility: Asklepios Klinik Lich
city: Limburg
country: Germany
facility: Vincenz-Krankenhaus
city: Magdeburg
country: Germany
facility: Klinik St. Marienstift
city: Magdeburg
country: Germany
facility: Städtisches Klinikum Magdeburg
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen u. Marburg
city: München
country: Germany
facility: Klinikum der Universität München-Innenstadt
city: München
country: Germany
facility: Klinikum Großhadern
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Offenbach
country: Germany
facility: Klinikum Offenbach GmbH
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus Paderborn
city: Radebeul
country: Germany
facility: Elblandkliniken Meißen-Radebeul GmbH
city: Regensburg
country: Germany
facility: Krankenhaus St. Josef
city: Rostock
country: Germany
facility: Klinikum Südstadt der Hansestadt Rostock
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum
city: Villingen-Schwenningen
country: Germany
facility: Klinikum der Stadt Villingen-Schwenningen GmbH
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital
city: Wiesbaden
country: Germany
facility: r. Horst Schmidt Kliniken GmbH
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia
city: Budapest
country: Hungary
facility: Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika
city: Győr
country: Hungary
facility: Petz Aladar Megyei Oktató Kórház, Onkoradiológia
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika
city: Tatabanya
country: Hungary
facility: Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály
city: Bari
country: Italy
facility: Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico
city: Bologna
country: Italy
facility: Ospedale S. Orsola Malpighi, Oncologia Medica
city: Campobasso
country: Italy
facility: Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia
city: Carpi (MO)
country: Italy
facility: DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini
city: Faenza
country: Italy
facility: Oncologia Medica Ospedale di Faenza - AUSL di Ravenna
city: Firenze
country: Italy
facility: Azienda Ospedaliera - Universitaria Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori di Milano
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia - Divisione di Ginecologia
city: Modena
country: Italy
facility: Policlinico di Modena, Dipartimento di Oncologia ed Ematologia
city: Napoli
country: Italy
facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
city: Potenza
country: Italy
facility: Azienda Ospedaliera San Carlo - Oncologia Medica
city: Reggio di Calabria
country: Italy
facility: Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova, Oncologia Medica
city: Roma
country: Italy
facility: Policlinico Umberto I D.H. Oncologico Oncologia Medica
city: Roma
country: Italy
facility: Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli
city: San Giovanni Rotondo (FG)
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia
city: Torino
country: Italy
facility: Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna
city: Bytom
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Nr 4
city: Czestochowa
country: Poland
facility: Oddzial Onkologii Wojewódzki Szpital Specjalistyczny
city: Gdansk
country: Poland
facility: Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Krakow
country: Poland
facility: Vesalius Kraków
city: Krakow
country: Poland
facility: "Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,
city: Lodz
country: Poland
facility: Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny
city: Olsztyn
country: Poland
facility: Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
city: Poznan
country: Poland
facility: Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych
city: Badalona
country: Spain
facility: Hospital Germans Trias y Pujol
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón, Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Elche
country: Spain
facility: Hospital de Elche, Servico de Oncologia
city: Girona
country: Spain
facility: Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez de Huelva
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaén
city: La Coruna
country: Spain
facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica
city: Lerida
country: Spain
facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
city: Madrid
country: Spain
facility: MD Anderson Internacional Espana
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos, Servicio de Oncología Medica
city: Mataró
country: Spain
facility: Hospital de Mataró
city: Málaga
country: Spain
facility: Hospital Clinico de Malaga. Servicio de Oncologia
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta, Servicio de Oncología
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany
name: Jacobus Pfisterer, MD
role: STUDY_CHAIR
affiliation: Memorial Sloan-Kettering Cancer Centre- NY
name: Paul Sabbatini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA
name: Jonathan Berek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy
name: Giovanni Scambia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain
name: Antonio Casado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland
name: Anna Pluzanska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic
name: Karel Cwiertka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary
name: Tamás Pintér, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Hotel Dieu - Paris, France
name: Eric Pujade-Lauraine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.