Ovarian Cancer Stage IV Clinical Trial
Official title:
Phase 1b/2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Bevacizumab, Paclitaxel Carboplatin as a Combinatorial Strategy in Subjects With BRCA-wild Type Platinum Sensitive Recurrent Ovarian Cancer
This is a single arm phase 1b/2 evaluation of the combination of oregovomab, and bevacizumab, paclitaxel carboplatin in adult subjects with CA125-associated, advanced recurrent epithelial ovarian, fallopian tube or peritoneal carcinoma (FIGO Stage III/IV) with BRCA-wild type, previously treated with 1 prior lines of therapy, and with platinum free intervals of >6 months since last platinum-based treatment.
This study is an open-label, single arm, phase 1b/II, multicenter study. In phase 1b part, the recommended phase 2 dose of oregovomab combined with bevacizumab, paclitaxel and carboplatin will be examined. Approximately 3 to 12 subjects("3+3" dose finding design) will be enrolled in phase 1b trial with starting dose of 2mg oregovmab. In Phase II trial, response rate of combination with oregovomab and bevacizumab, paclitaxel will be examined. Based on Simon's two stage model, 8 patients will be enrolled in first stage, after review of efficacy (response rate) of study treatment, 30 additional subjects for second stage of phase 2 will be enrolled. Considering 10% of screening failure rate, overall 42 patients will be enrolled in phase 2 trial. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03304210 -
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT00945191 -
Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer
|
Phase 2 | |
| Recruiting |
NCT03579394 -
Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
|
N/A | |
| Recruiting |
NCT04701645 -
Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer
|
Phase 1 | |
| Recruiting |
NCT03126812 -
Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT03162562 -
The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer
|
Phase 1 | |
| Recruiting |
NCT03922776 -
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer
|
N/A | |
| Completed |
NCT03085238 -
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
|
N/A | |
| Not yet recruiting |
NCT06017557 -
Predicting Outcome of Cytoreduction in Advanced Ovarian Cancer, Using a Machine Learning Algorithm and Patterns of Disease Distribution at Laparoscopy (PREDAtOOR)
|
N/A | |
| Suspended |
NCT05479045 -
A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
|
Phase 2 | |
| Completed |
NCT05005650 -
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy
|
||
| Recruiting |
NCT03899610 -
A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)
|
Phase 2 | |
| Recruiting |
NCT04789694 -
Prehabilitation in Gynaecological Cancer Patients
|
Phase 3 | |
| Not yet recruiting |
NCT05187208 -
PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer
|
Phase 4 | |
| Recruiting |
NCT06272240 -
Tumor Microenvironment in Ovarian Cancer
|
||
| Not yet recruiting |
NCT06268665 -
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
|
Phase 2 | |
| Active, not recruiting |
NCT03275506 -
PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer .
|
Phase 2 | |
| Recruiting |
NCT06290193 -
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery
|
Phase 2 | |
| Completed |
NCT02258165 -
Impact of Gated PET/CT in the Diagnosis of Advanced Ovarian Cancer
|
||
| Recruiting |
NCT03693248 -
Reduction Of Cycles of neOadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer
|
Phase 3 |