Name of Protocol

A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

Purpose

This is a Phase 2 randomized study with two treatment arms to compare the efficacy of oregovomab when combined with first-line chemotherapy to first-line chemotherapy alone in female patients with advanced ovarian cancer.

This study is to confirm previous results that showed oregovomab assisted the body in producing a positive immune response to CA125, a target that has been identified on ovarian cancer cells, in patients with stage III-IV ovarian cancer when they were receiving chemotherapy for their disease.

Endpoints

The primary aim of the study is to see how well these patients with advanced ovarian cancer make an immune response to CA125 by using a specific test of the patient's blood. The study will also look at the side effects of the oregovomab, other immune response parameters, how well the patients respond to the treatment of their disease.

Timeline and Recruitment

This study began in in June 2012 and was completed in December 2017.There are 97 patients enrolled in this study and we presented positive interim clinical data at ASCO 2017. We expect final data to be released in 2018.

Inclusion Criteria

  • Female, aged 18 to 75
  • Have newly diagnosed epithelial adenocarcinoma of ovaria, tubal or peritoneal origin
  • Have preoperative CA125 levels > 50 U/ml
  • Have optimal cytoreduction (RT=0)
  • Be anticipated to have first-line chemotherapy infusion within 6 weeks after surgery
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Participating Centers

Centers in Italy

Prof. Roberto Angioli
Policlinico Universitario Campus Bio-Medico Di Roma - Roma (RM), Ginecologia E Ostetricia
00128 Roma


Prof. Giovanni Scambia
Policlinico Universitario Gemelli Di Roma - Roma (RM), Ginecologia E Ostetricia
00168 Roma


Dr. Francesco Raspagliesi
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano



Dr.ssa Germana Tognon
Azienda Ospedaliera Spedali Civili di Brescia
Brescia


Dr. Luigi Frigerio
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo



Dr. Benedetti Panici
Policlinico di Roma Umberto
Roma


Dr. Pavese
Struttura Complessa di Oncologia Ospedale San Pietro Fatebenefratelli
Roma


Dr. Scollo
Azienda Ospedaliera Cannizzaro di Catania
Catania

Centers in United States

Dr. Molly Brewer
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030


Dr. Michael Method
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601


Dr. Patricia Braly
Women Cancer Care
Covington, LA, United States, 70433


Dr. Jonathan Berek
Stanford University Medical Center
Stanford, California, United States, 94305


Dr. Robert Holloway
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804