Advanced Ovarian Cancer Clinical Trial
Official title:
A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)
The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).
The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months. The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03611179 -
Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06055348 -
SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT04135521 -
Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer
|
||
| Completed |
NCT01462149 -
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
|
Phase 2 | |
| Terminated |
NCT03292172 -
A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer
|
Phase 1 | |
| Completed |
NCT04360629 -
Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer
|
N/A | |
| Active, not recruiting |
NCT00516724 -
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
|
Phase 1 | |
| Completed |
NCT03158935 -
The ACTIVATE (Adoptive Cell Therapy InVigorated to Augment Tumor Eradication) Trial
|
Phase 1 | |
| Completed |
NCT05775549 -
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
|
||
| Active, not recruiting |
NCT03737643 -
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
|
Phase 3 | |
| Completed |
NCT01290471 -
Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors
|
Phase 1 | |
| Recruiting |
NCT04862325 -
SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS
|
N/A | |
| Completed |
NCT01989546 -
Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04556539 -
Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT03161132 -
Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin
|
Phase 2 | |
| Active, not recruiting |
NCT04065009 -
The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT01844986 -
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
|
Phase 3 | |
| Not yet recruiting |
NCT05924776 -
Plasmodium Immunotherapy for Advanced Ovarian Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03878849 -
Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP®
|
Phase 2 |