AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
Ovarian CancerPrevious studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile. AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
MesotheliomaMesotheliomas Pleural16 moreTC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.
Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer...
Ovarian CancerEpithelial ovarian cancer is mostly diagnosed at late stage (III/IV), and the standard treatment for ovarian cancer includes primary debulking surgery and platinum-based adjuvant chemotherapy. However, scholars suggest that neoadjuvant chemotherapy can be used to reduce the tumor load and control the patient's condition. The aim of this study is to verify the efficacy of primary debulking surgery versus neoadjuvant chemotherapy.
Patients Derived Organoids in Ovarian Cancer
Ovarian CancerAmong cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response. For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.
A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard...
Solid TumorBreast Cancer3 moreThis proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant to standard of care therapies, for advanced/ metastatic solid tumors.
FRAGINOC Study: Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial...
Ovarian CancerFrailtyOvarian cancer (OC) is the fifth most common cause of cancer death. More than 40% are older than 70 years. The standard treatment is radical surgery combined with chemotherapy. More than 40% of the Danish patients will never undergo surgery. Frail and immunodeficient older patients are at higher risk of complications, and immunomodulating treatment as chemotherapy results in different outcomes in comparable patients. No accurate validated screening tool to identify frail and immunodeficient OC women exists. Optimization through comprehensive geriatric assessment (CGA) and physical training before and during treatment may improve outcomes and decrease associated risks. Aim: Primary endpoints will be to determine whether a CGA and physical training vs standard of care can increase the proportion of patients later on referred to interval debulking surgery, and examine the performance of validated screening tests in predicting impairments in CGA. Other endpoints will be to evaluate if intervention can improve completion of chemotherapy, to examine the association between frailty screening scores and selected biomarkers with treatment outcomes, including complications and quality of life, and ultimately to develop an improved frailty screening tool based on known screening tools, functional tests and biomarkers identifying patients who will benefit from CGA. Method: This is a nationwide, randomized intervention study. Patients ≥70 years diagnosed with primary OC at the Gynecological departments of Rigshospitalet, Odense and Roskilde University Hospitals will be included. In an interdisciplinary collaboration between medical specialists in oncology, gynecology and geriatrics, included patients will be screened for frailty using validated screening tools and functional tests. Specific biomarkers and immunologic profile will be assessed in all patients. Patients selected for neoadjuvant chemotherapy will be randomized to receive CGA or standard of care. Patients selected for primary debulking surgery or palliation will be followed in an observational cohort. Perspective: The development of a validated screening tool for frailty assessment and immunological status will help us identify frail patients who may need optimization before treatment, resulting in more patients getting optimal treatment (either surgery or chemotherapy), prevent post-treatment complications and avoid palliative patients from undergoing a redundant complex treatment.
DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Teenage/Young...
Solid TumorHaematological Malignancy9 moreThis clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved as standard of care treatment for adult patients with metastatic breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Trastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With...
Ovarian CancerOvarian Carcinoma3 morePhase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab.
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
Ovarian CancerThe study's purpose is to understand the effects of a new treatment (suba-itraconazole and tamoxifen) in epithelial ovarian cancer. Who is it for? Patients may be eligible to join this study with ovarian cancer resistant to platinum-based chemotherapy agents Study Details: Participants will receive different doses of tamoxifen and suba-itraconazole to determine the optimal combination dose. Participants will be seen by the investigators once a week for the first 3 weeks and then once every 4 weeks. Participant will be reviewed by a clinician and undergo regular blood tests, cardiac monitoring and imaging assessments.
Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib...
CarcinomaOvarian EpithelialThis trial is a multicenter, single-arm, phase II study evaluating the efficacy of pembrolizumab and bevacizumab in combination with platinum-based chemotherapy (PBC) followed by pembrolizumab, bevacizumab and olaparib as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.This study is planned to enroll eligible 35 patients from multiple study sites in Japan.