Table 4. Current Clinical Trials investigating Immunotherapy in Ovarian Cancer.
| Trial Identifier |
Phase |
Objective |
|---|---|---|
| Cytokines | ||
|
NCT00003408 |
II |
To study the effectiveness of biological therapy with sargramostim (GM-CSF), IL-2 and INF-α following high-dose chemotherapy and autologous stem cell transplantation in treating patient who have cancer (including ovarian cancer) |
|
NCT00157573 |
II |
To examine the ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian, fallopian tube or primary peritoneal cancer |
| NCT00659178 | I | To assess the safety and biological activity of IL-18 (SB-485232) IV infusion in combination with Doxil in Advanced Stage Epithelial Ovarian Cancer |
| Vaccines | ||
|---|---|---|
|
NCT00001827 |
II |
To determine the safety and immunogenicity of vaccination with a p53 peptide in ovarian cancer patients |
|
NCT00017537 |
I |
To study the effectiveness of MVF-HER-2(628–647) and CRL1005 Copolymer Adjuvant in Patients with metastatic cancer (including ovarian cancer) |
|
NCT00088413 |
I |
To evaluate the safety and tolerability of PANVAC-V priming vaccine and PANVAC-F boosting vaccine, which produce CEA and MUC-1, in combination with sargramostim (GM-CSF) in adults with metastatic carcinoma including ovarian cancer |
|
NCT00423254 |
I |
To evaluate the safety and immune response to DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM, a multi-component immune based therapy, in patients with advanced cancer, including ovarian cancer |
|
NCT00437502 |
I |
To evaluate the safety of a peptide vaccine (consisting of 12 different tumor-rejection antigens) plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women with Advanced Stage Ovarian, Tubal or Peritoneal Cancer |
|
NCT00585845 |
I |
To evaluate the safety and tolerability of CRS207, a live attenuated Listeria monocytogenes expressing human mesothelin, in patients with advanced cancer of the ovary or pancreas, non-small cell lung cancer or advanced malignant epithelial mesothelioma |
|
NCT00660101 |
I/II |
To determine the safety and efficacy of a DNP-Modified Autologous Ovarian Tumor Cell vaccine as therapy in ovarian cancer patients after relapse |
|
NCT00948961 |
I/II |
To examine the safety and tolerability of CDX-1401 in combination with Resiquimod and/or Poly-ICLC in patient with advanced cancers that are known to express the NY-ESO-1 protein (including ovarian cancer) |
|
NCT01095848 |
I |
To determine the safety and immunogenicity profile of DPX-0907 (consisting of 7 tumor-specific HLA-A2-restricted peptides, a universal T helper peptide, a polyneucleotide adjuvant, a liposome and Montanide ISA51 VG) to treat breast, ovarian and prostate cancer |
|
NCT01376505 |
I |
To determine the safety and effectiveness of vaccination combining two chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptides emulsified in ISA 720 and Nor-MDP Adjuvant in Patients with Advanced Solid Tumors (including ovarian cancer) |
|
NCT01416038 |
I/II |
To determine the safety and immunogenicity profiles of DPX-Survivac, designed to target Survivin, with a regimen of low dose oral cyclophosphamide in the treatment of ovarian, fallopian tube and peritoneal cancers |
|
NCT01522820 |
I |
To determine the safety and immunogenicity of the DEC-205-NY-ESO-1 fusion protein vaccine, with and without sirolimus (an mTOR inhibitor), in patients with NY-ESO-1 expressing solid tumors (including ovarian) |
|
NCT01526473 |
I |
To determine the safety and immunogenicity of HER2 VRP (AVX901) in patients with advanced or metastatic malignancies that express HER2 (including ovarian) |
| NCT01312389 | I/II | To determine the feasibility, safety and immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysates (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen, a Toll-like receptor 3 agonist |
| Monoclonal Antibody | ||
|---|---|---|
|
NCT00034138 |
I/II |
To compare the safety, immunity and pharmokinetic profile of OvaRex mAb-B43.13 (oregovomab) ascites fluid product and OvaRex mAb-B43.13 cell culture product in a patients with Stage III/IV epithelial ovarian cancer |
|
NCT00034372 |
II |
To compare the time to disease relapse of patients who demonstrate an immune response to OvaRex mAb-B43.13 (Oregovomab) with time to disease relapse of those who do not demonstrate an immune response to OvaRex mAb-B43.13 |
|
NCT00086632 |
II |
To determine if oregovomab received during front-line chemotherapy for ovarian cancer can create anti-tumor immune responses and thus provide a survival benefit |
| NCT00050375 | III | To compare the time to disease relapse between post chemotherapy consolidation with oregovomab (OvaRex® mAb-B43.13) or placebo in women with ovarian, tubal or peritoneal cancer. |
| Cellular Immunotherapy | ||
|---|---|---|
|
NCT00003887 |
II |
To study the effectiveness of donated white blood cells in treating patients who have relapsed cancer (including ovarian cancer) following allogeneic transplantation of donated bone marrow or peripheral stem cells |
|
NCT00004604 |
I |
To study the effectiveness of carcinoembryonic antigen (CEA) antigen RNA-pulsed autologous DC cancer vaccine in treating patients who have metastatic cancer (including ovarian cancer) that has not responded to prior treatment |
|
NCT00005956 |
I |
To study the effectiveness of HER2/Neu Intracellular Doman (ICD) Protein-pulsed, Autologous, Cultured DCs followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) in Patients with no evidence of disease after standard treatment for HER2/Neu Expressing Malignancies (including ovarian cancer) |
|
NCT00027534 |
I |
To study the effectiveness of autologous DCs infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA (including ovarian cancer) |
|
NCT00101257 |
I |
To study the side effects and best dose of Autologous CD4+ Antigen-Specific T cells following in vitro stimulation with NY-ESO-1 pulsed DCs in patients with stage III or stage IV EOC or PPC |
|
NCT01456065 |
I |
To determine the safety of active immunotherapy with fully mature, Telomerase Reverse Transcriptase-mRNA and Survivin peptide double loaded DCs (Procure®) in patient with advanced ovarian cancer, enrolled within 12 weeks after completing primary therapy |
|
NCT00603460 |
I II |
To determine the feasibility and safety of administering vaccine-primed, ex vivo CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine. To assess the distribution of progression-free survival at 6 mo for patients treated with maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L boost vaccination and metronomic oral cyclophosphamide. |
|
NCT01132014 |
0 |
To determine the feasibility, safety and immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC), administered intranodally alone or in combination with either intravenous Daclizumab or with a combination of Daclizumab and intravenous Bevacizumab. |
|
NCT00703105 |
II |
To determine if immunoregulatory T-cell inhibition by Ontak followed by the administration of an autologous tumor lysate-loaded dendritic cell vaccine enhances the immune response in patients with relapsed/refractory ovarian cancer |
| NCT00683241 | I | To determine the feasibility and safety of administering DCVax-L intradermally combined with intravenous bevacizumab and oral metronomic cyclophosphamide in patients with recurrent ovarian or primary peritoneal cancer |
| Combination/Other | ||
|---|---|---|
|
NCT00194714 |
I/II |
To determine the safety and efficacy of monthly HER2/Neu Specific Cytotoxic T Cell vaccination in patients with HER2 overexpressing Stage IV breast and ovarian cancer who are on maintenance trastuzumab alone after being treated with chemotherapy and trastuzumab or trastuzumab alone |
| NCT00004021 |
II |
Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with standard therapy in terms of response rate in patients with stage III or IV ovarian cancer |
|
NCT00496860 |
I |
To evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801(a biologic compound compose of IL-2 genetically fused to a human soluble T-cell receptor directed against p53) in previously treated patients with progressive metastatic malignancies, including ovarian cancer |
|
NCT01384253 |
I |
To determine the toxicity profile of intraperitoneal 212Pb-TCMC-Trastuzumab infusion, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers |
| NCT00019084 | II | To study the effectiveness of tumor specific mutated p53 or Ras peptides alone or in combination with cellular immunotherapy with peptide activated lymphocytes (PALs) along with subcutaneous IL-2 in treating patients who have advanced cancer (including ovarian cancer) |