A Phase 2/3 interventional study of Abagovomab and Placebo in Ovarian Cancer, sponsored by Menarini Group. Terminated at 150 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-24.
Sponsored by Menarini Group · Phase 2/3, Interventional, and Treatment
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 888 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Menarini Group is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Adequate hematologic, renal and hepatic function:
Exclusion Criteria:
Patients are ineligible to participate in the study, if any of the following criteria are present:
Biological: Abagovomab
Biological: Placebo
2 mg/ml SC (subcutaneously)
2 mg/ml SC (subcutaneously)
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.
Time frame: Every 12 weeks up to recurrence or up to 3 months after last administered dose
Overall Survival
2 years survival rate
Time frame: 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.
Time frame: 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).
Time frame: 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 population was recruited in 139 sites (Hospitals/University Clinics) distributed in Europe (Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland and Spain) and US. Date of first patient randomised: 08 December 2006 Date of last patient randomised: 26 December 2008
| Milestone | Abagovomab | Placebo |
|---|---|---|
| Started | 593 | 295 |
| Treated | 592 | 294 |
| Completed | 545 | 272 |
| Not completed | 48 | 23 |
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.
| days | Abagovomab | Placebo |
|---|---|---|
| Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) | 403 (323 to 414) | 402 (323 to 487) |
2 years survival rate
| Percentage of participants | Abagovomab | Placebo |
|---|---|---|
| Overall Survival | 80 | 79 |
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.
| participants | Abagovomab | Placebo |
|---|---|---|
| Patients with at least 1 Adverse Event (AE) | 564 | 278 |
| Patients with at least 1 Adverse Drug Reaction ADR | 507 | 246 |
| Patients with at least 1 Serious Adverse Event SAE | 141 | 72 |
| Patients with at least 1 Serious ADR (SADR) | 10 | 3 |
| Patients with at least 1 AE leading to withdrawal | 93 | 57 |
| Patients with at least 1 AE resulted in death | 8 | 4 |
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).
| ng/ml | Abagovomab |
|---|---|
| Ab3 (baseline) | 0 (0 to 118000) |
| Ab3 (week 10) | 63550 (0 to 777000) |
| Ab3 (end of treatment) | 493000 (0 to 2720000) |
Collected over 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abagovomab | — | 141/592 (23.8%) | 532/592 (89.9%) |
| Placebo | — | 72/294 (24.5%) | 261/294 (88.8%) |
| Event | Abagovomab | Placebo |
|---|---|---|
| Ovarian neoplasms malignant (excl germ cell)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 61/592 | 41/294 |
| Metastases to specified sitesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 14/592 | 13/294 |
| Gastrointestinal stenosis and obstruction NECGastrointestinal disorders | 14/592 | 12/294 |
| Peritoneal and retroperitoneal disordersGastrointestinal disorders | 18/592 | 6/294 |
| Gastrointestinal and abdominal pains (excl oral and throat)Gastrointestinal disorders | 11/592 | 4/294 |
| Pneumothorax and pleural effusions NECRespiratory, thoracic and mediastinal disorders | 7/592 | 5/294 |
| Abdominal hernias, site unspecifiedGastrointestinal disorders | 1/592 | 4/294 |
| Nausea and vomiting symptomsGastrointestinal disorders | 3/592 | 4/294 |
| Non-site specific procedural complicationsInjury, poisoning and procedural complications | 7/592 | 0/294 |
| Streptococcal infectionsInfections and infestations | 1/592 | 3/294 |
| Event | Abagovomab | Placebo |
|---|---|---|
| Injection site reactionsGeneral disorders | 467/592 | 222/294 |
| Asthenic conditionsGeneral disorders | 191/592 | 89/294 |
| Gastrointestinal and abdominal pains (excl oral and throat)Gastrointestinal disorders | 183/592 | 81/294 |
| Musculoskeletal and connective tissue pain and discomfortMusculoskeletal and connective tissue disorders | 171/592 | 79/294 |
| Upper respiratory tract infectionsInfections and infestations | 142/592 | 70/294 |
| Joint related signs and symptomsMusculoskeletal and connective tissue disorders | 134/592 | 67/294 |
| Nausea and vomiting symptomsGastrointestinal disorders | 130/592 | 64/294 |
| Diarrhoea (excl infective)Gastrointestinal disorders | 98/592 | 41/294 |
| Headaches NECNervous system disorders | 83/592 | 38/294 |
| Gastrointestinal atonic and hypomotility disorders NECGastrointestinal disorders | 82/592 | 38/294 |
| Age, Categorical(Participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 447 | 227 | 674 |
| >=65 years | 145 | 68 | 213 |
| Age Continuous(years) | Abagovomab | Placebo | Total |
|---|---|---|---|
| Mean | 56.4 ± 10.57 | 56.0 ± 10.47 | 56.3 ± 10.53 |
| Sex/Gender, Customized(participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| Female | 593 | 295 | 888 |
| Region of Enrollment(participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| France | 1 | 2 | 3 |
| United States | 91 | 47 | 138 |
| Hungary | 17 | 8 | 25 |
| Czech Republic | 54 | 28 | 82 |
| Poland | 53 | 25 | 78 |
| Spain | 55 | 48 | 103 |
| Belgium | 19 | 4 | 23 |
| Germany | 206 | 93 | 299 |
| Italy | 97 | 40 | 137 |
| Histology of ovarian tumor(participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| Serous/papillary | 481 | 245 | 726 |
| Endometrioid | 38 | 21 | 59 |
| Mucinous | 6 | 3 | 9 |
| Undifferentiated | 14 | 7 | 21 |
| Mixed tumor | 18 | 7 | 25 |
| Others | 33 | 12 | 45 |
| missing | 3 | 0 | 3 |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS)(participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| 0 | 460 | 240 | 700 |
| 1 | 131 | 55 | 186 |
| 2 | 2 | 0 | 2 |
| Grade of histologic differentiation(participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| G1-G2 | 160 | 82 | 242 |
| G3-G4 | 365 | 185 | 550 |
| GX | 12 | 4 | 16 |
| not done | 56 | 24 | 80 |
| International Federation of Gynecology and Obstetrics (FIGO) stage(participants) | Abagovomab | Placebo | Total |
|---|---|---|---|
| III | 513 | 252 | 765 |
| IV | 80 | 42 | 122 |
| missing | 0 | 1 | 1 |
2 further baseline measures are reported on the registry.
Showing the first 100 of 150 sites across 9 countries.
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Menarini Group