MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
Ovarian Neoplasm EpithelialFallopian Tube Neoplasms4 moreThe purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo. The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer
Ovarian Cancer RecurrentA recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood. The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only. When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did. Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.
Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard...
Epithelial Ovarian CancerGastric Adenocarcinoma7 moreA Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: Triple negative breast cancer Epithelial ovarian cancer Non-small cell lung cancer Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma Small cell lung cancer HR+/ HER2-breast cancer Head and neck squamous cell carcinoma Endometrial carcinoma Urothelial carcinoma
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Ovarian...
Ovarian CancerPeritoneal Carcinomatosis1 more10 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety, tolerability, and efficacy of the recombinant herpes simplex virus I, R130 in patients with relapsed/refractory ovarian cancer.
Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
Small Cell Ovarian CarcinomaSmall cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.
Study of REGN5668 Administered in Combination With Cemiplimab or REGN4018 in Adult Women With Recurrent...
Ovarian CancerFallopian Tube Cancer1 moreThe primary objectives of the study are: In the Dose Escalation Phase: To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5668 alone and in separate combinations with cemiplimab or REGN4018, in order to determine a maximally tolerated dose(s) (MTD) or recommended phase 2 dose(s) (RP2D) of these combinations In the Dose Expansion Phase: To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018, (separately by cohort and combination) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 The secondary objectives of the study are: In the Dose Escalation Phase: To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as determined by ORR by RECIST 1.1 In the Dose Expansion Phase: To characterize the safety profile in each expansion cohort To characterize the PK of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) In both the Dose Escalation and Dose Expansion Phases: To assess preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as measured by ORR based on immune based therapy RECIST (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) based on RECIST 1.1 and iRECIST To assess changes in CA-125 levels from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination) Immunogenicity of REGN5668, alone and in combinations with cemiplimab or REGN4018
Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian...
Epithelial Ovarian CancerThis is single center, open-label phase 1 dose escalation trial that uses modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent...
Platinum-sensitive Ovarian CancerRelapsed Ovarian CancerThe proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).
Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer
Ovarian CancerThis prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.
Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors
Metastatic Malignant Solid NeoplasmRecurrent Malignant Solid Neoplasm2 moreThis phase I/Ib trial is to find out the best dose, possible benefits and/or side effects of BET bromodomain inhibitor ZEN-3694 (ZEN003694) when given in combination with nivolumab with or without ipilimumab in treating patients with solid tumors. ZEN003694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ZEN003694 in combination with nivolumab with or without ipilimumab may shrink or stabilize solid tumors.