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Fallopian Tube Neoplasms clinical trials

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NCT ID: NCT04616534 Active, not recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors

Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.

NCT ID: NCT04611126 Recruiting - Peritoneal Cancer Clinical Trials

T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer

Start date: April 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances. In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab. Only transient clinical responses where observed. Between 90-100 % of infused T-cells in our previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function. In this study adding the LAG-3 antibody Relatlimab to the ACT-regimen described above may therefore well unleash T-cell antitumor efficacy by blocking the known LAG-3-MHC-II interaction. With this study the aim is to demonstrate that adding the lag-3-inhibitor Relatlimab to the above treatment regimen is feasible and tolerable. The study will elucidate whether the combination Relatlimab-Nivolumab leads to objective responses and improves progression free survival (PFS).

NCT ID: NCT04598321 Terminated - Ovarian Cancer Clinical Trials

BrUOG 390: Neoadjuvant Treatment With Talazoparib

Start date: March 29, 2021
Phase: Phase 1
Study type: Interventional

Ovarian cancer is the most fatal gynecologic cancer; in the US alone an estimated 22,000 women will be diagnosed in 2019, with over 13,000 dying of the disease. Approximately half of epithelial ovarian cancers (EOC) exhibit defective DNA repair through alterations in the homologous recombination (HR) pathway, with 14% accounted for by germline mutations in BRCA genes (mBRCA); this goes up to about one in five (20%) women when one includes tumor-associated (somatic) mBRCA.The approach to women with mBRCA-associated ovarian cancer has heralded precision treatment in our field with the availability of PARP inhibitors. Now indicated as treatment for women with documented mBRCA (genomic or somatic), it also has shown significant benefits for women with recurrent EOC who respond to platinum-based therapy when administered as maintenance treatment.

NCT ID: NCT04590326 Recruiting - Ovarian Cancer Clinical Trials

A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018

Start date: December 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is researching an investigational drug called REGN5668. Participants will receive additional investigational drugs in combination with REGN5668. These additional drugs include cemiplimab or REGN4018 (with or without sarilumab). The main purposes of this study are to: - Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus - Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: - Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab or REGN4018 - How REGN5668 works in the body either alone and/or in combination with cemiplimab or REGN4018 - How much of the study drugs (REGN5668, cemiplimab, REGN4018) are in the blood - To see if REGN5668 in combination with cemiplimab or REGN4018 works to treat cancer - To find out how safe, tolerable, and effective in mitigating Cytokine Release Syndrome (CRS) sarilumab pretreatment is when given before REGN4018

NCT ID: NCT04575961 Recruiting - Ovarian Cancer Clinical Trials

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

PERCEPTION
Start date: February 22, 2022
Phase: Phase 2
Study type: Interventional

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) 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).

NCT ID: NCT04575935 Recruiting - Clinical trials for Ovarian Endometrioid Adenocarcinoma

Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial

Start date: August 5, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and/or improving quality of life after surgery.

NCT ID: NCT04556071 Recruiting - Neoplasms Clinical Trials

Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer

AVANIRA3
Start date: November 6, 2020
Phase: Phase 2
Study type: Interventional

Niraparib is an oral, potent and highly selective PARP1/2 inhibitor. It can be used as a single drug in HRD positive ovarian cancer patients for multi-line therapy. Bevacizumab is a recombinant humanized monoclonal antibody that inhibits tumor angiogenesis and is also recommended for the treatment of recurrent ovarian cancer. Clinical studies showed that niraparib combined with bevacizumab could significantly prolong progression free survival of platinum sensitive recurrent ovarian cancer. We intend to conduct a single-arm, prospective, open-label, phase II study to observe the efficacy and safety of niraparib combined with bevacizumab in the treatment of FIGO III/IV platinum refractory/resistant ovarian cancer, fallopian tube cancer and primary peritoneal cancer. The results are expected to provide more effective and precise treatment for platinum resistant recurrent/refractory ovarian cancer patients.

NCT ID: NCT04546373 Completed - Clinical trials for Fallopian Tube Cancer

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

Start date: September 30, 2020
Phase:
Study type: Observational

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).

NCT ID: NCT04539327 Completed - Clinical trials for Fallopian Tube Cancer

Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study

Start date: July 29, 2020
Phase:
Study type: Observational

The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib). A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant. The specific objectives of the study are: - To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data). - To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data). - To show that data obtained in clinical trials could be reproduced in non-screened patients.

NCT ID: NCT04537702 Completed - Clinical trials for Fallopian Tube Cancer

Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients

Start date: August 8, 2019
Phase: N/A
Study type: Interventional

Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. Patients will be randomized to either the streamlined or the traditional counseling arm. Those in the streamlined group will watch a brief educational video and have the option of immediate testing; The traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. The primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. The study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.