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96 active trials for Fallopian Tube Cancer

Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

DICE is a randomised study recruiting 126 women over 3 years from hospitals in the UK and Germany. Eligible patients will have tissue based diagnosis of advanced/recurrent ovarian cancer (clear cell, endometrioid or high grade serous or carcinosarcoma), have had chemotherapy before, and be platinum-resistant (the cancer has returned/grown significantly during or within 6 months of platinum-containing chemotherapy).

Start: September 2018

A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers

The ultimate goal of the study is to identify potential biomarkers, immune gene expression signatures, and co-stimulatory pathways that may be used to understand the effect of immune checkpoint inhibitors on gynecologic cancers.

Start: June 2016

Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer

While significant progress has been made in the treatment and prognosis of ovarian cancer, this progress has mostly shown benefits for younger women. This study aims to understand two things: How body composition (the amount of muscle and water versus fat in in the body) affects the dose and side effects of chemotherapy; and the biological reason for the worse prognosis with aging. To get a good view of these effects, investigators are asking the help of both younger and older women for this project.

Start: August 2016

Study of REGN5668 Administered in Combination With Cemiplimab or REGN4018 in Adult Women With Recurrent Ovarian Cancer.

The 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

Start: December 2020

Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers

Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach, colorectal, appendiceal, and gynecological primary origin will be screened by pathology and staging to see if they are eligible to undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). To be eligible for the study, patients must be over 18 years of age, have appropriate pathology and stage with disease confined to the peritoneal cavity, have a good performance status, have laboratory values that fall within safe ranges to undergo an operation and receive intraperitoneal chemotherapy. The chemotherapeutic agent and dose will be assigned based on pathological diagnosis in accordance with current standard of care. Surgery will be performed with the goal of removing all visible tumor that may require removal of adjacent organs. Once only microscopic disease is present, the chemotherapy will be delivered directly into the peritoneum via intraperitoneal hyperthermia and perfusion device. This will continue for 90 minutes. Patients will be followed for tumor response, survival, toxicity, complications, quality of life, and tumor markers. They will have regular follow up visits with the surgeon, undergo routine surveillance imagings, and receive follow up phone calls periodically.

Start: May 2018

Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT

The purpose of this study is to determine, whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC) Objectives the impact of preoperative PET/CT compared to CT on EOC stage definition to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic results serve as the reference standard. to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen 125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant chemotherapy and primary treatment of EOC to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG criteria Methods All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant chemotherapy (NACT) and 4 weeks after completion of primary platinum-based chemotherapy. CA125 and HE4 levels are measured pre-operatively, with every chemotherapy cycle and regularly during follow-up until 1st disease relapse

Start: October 2009

Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer

This is a phase II, single arm, multi-centre study to assess the efficacy of pembrolizumab in combination with platinum-based chemotherapy (investigator's choice: carboplatin + gemcitabine or carboplatin + pegylated liposomal doxorubicin or carboplatin monotherapy) administered concurrent to chemotherapy and in maintenance, in patients with low grade ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) having platinum-sensitive relapse (platinum-free interval > 6 months).

Start: April 2021

Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab

This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Its primary objective is to assess whether adding bevacizumab to ixabepilone improves progression-free survival in its target population. Study participants will be stratified by (a) study site and (b) previous receipt of bevacizumab prior to randomization.

Start: April 2017

A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

Start: August 2020

MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase I study to establish safety and feasibility of intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy

Start: October 2018

A Trial Evaluating TG4050 in Ovarian Carcinoma.

This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.

Start: December 2019

A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib

This research study is evaluating three drugs called Nivolumab, Bevacizumab, and Rucaparib as a possible treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.

Start: November 2016

Genomic BRCA and Extensive ovArian Cancer Testing

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

Start: December 2019

CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib

This protocol is designed to provide patients currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Patients in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.

Start: February 2021

European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer

This study will be performed in women with platinum-sensitive, high-grade serous, high-grade endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or primary peritoneal cancer (proven by central histo-pathological review). A total of 120 subjects will be randomized (1:1:1) to three different treatment arms: (A) Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) // (B) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) // (C) Second experimental arm (arm C): Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w). Chemotherapy treatment will be given for 6 cycles, maintenance treatment with Ganetespib will be given for a maximum of 9 months or until disease progression, maintenance treatment with Niraparib can continue until disease progression.

Start: November 2018

Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

In April 2017, Tesaro, Inc. opened an expanded access program (EAP) to make niraparib, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor, available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy, mainly for BRCA wild-type (BRCAwt) tumor patients, a clear unmet medical need for these ovarian cancer patients. As of 19 August 2019, the EAP closing date, there were 446 patients enrolled in 105 Spanish sites. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF). This study seeks to evaluate the safety profile and dose adjustments of niraparib in platinum sensitive recurrent ovarian cancer patients treated in a real world setting within the Spanish expanded access program (EAP).

Start: September 2020

Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer

This is a single arm feasibility study in patients with primary FIGO stage IV serous ovarian, peritoneal, or fallopian tube cancer to evaluate neo-adjuvant + adjuvant pembrolizumab for its capacity to induce and broaden T cell responses against tumor neo-antigens.

Start: November 2017

Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy

The receptor tyrosine kinase AXL is a pathway that plays a crucial role in metastasis and chemoresistance. Overexpression of AXL has been associated with metastasis, recurrence, and chemoresistance in various cancer including ovarian cancer[16, 17]}. Targeting AXL is an attractive approach because it is overexpressed among patients with epithelial ovarian cancer and strongly associated with advanced stages, high grade cancer and shorter median survival time. AVB-S6-500 is a potent AXL inhibitor by binding to the ligand Gas6. Pre-clinical studies found that AVB-S6-500 was efficacious in ovarian cancer xenograft tumor models. Interventions which would increase the proportion of patients achieving pCR in this patient population could impact survival favorably and are of interest for study.

Start: June 2021

GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer

The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer and peritoneal carcinomatosis.

Start: May 2016

PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer

Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair double-stranded breaks in DNA. Treating these tumors with poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors results in the specific killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of ovarian cancer patients with PARP inhibitors has resulted in improved progression free survival (PFS), but not overall survival (OS). It's not completely understood why this is the case, but some preclinical studies using ovarian cancer models in mice have suggested that combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors improves long-term survival. Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.

Start: February 2016