cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
NCT05366881 · Brain Cancer,
Breast Cancer, Bladder Cancer
RecruitingThis is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Phase—
TypeObservational
Age40 Years
WhereDuarte, California, United States + 16 more
SponsorAdela, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
NCT06787612 ·
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
RecruitingThis study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug and fianlimab is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 53 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
NCT04291612 · Endometrial Cancer, Endometrioid Adenocarcinoma, Endometrial Cancer Stage I
RecruitingThis study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.
Phase—
TypeObservational
Age18 Years
WhereHartford, Connecticut, United States + 18 more
SponsorMemorial Sloan Kettering Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
NCT04251052 · Ovarian Carcinoma
RecruitingThis clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
PhaseNA
TypeInterventional
Age35 Years – 50 Years
WhereBirmingham, Alabama, United States + 548 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
NCT07213804 · Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
RecruitingThis is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 265 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
NCT04585750 · Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer
RecruitingThe Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years
WhereIrvine, California, United States + 76 more
SponsorPMV Pharmaceuticals, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
RecruitingThis Phase 3 study will be conducted in different countries around the world with up to about 544 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer. Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) for each participant will be different for every participant.
PhasePhase 3
TypeInterventional
Age18 Years
WhereMiami, Florida, United States + 15 more
SponsorGenmab
▾Tap for detailsClick for full details — eligibility, all locations, contacts Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
RecruitingThis study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
Phase—
TypeObservational
Age40 Years – 75 Years
WhereAnchorage, Alaska, United States + 744 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT03452774 · Cancer, Metastatic,
Cancer, Cancer of Pancreas
RecruitingInternational registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 67 more
SponsorMassive Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
NCT04575935 · Advanced Ovarian Carcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor
RecruitingThis 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.
PhasePhase 3
TypeInterventional
Age18 Years
WhereMiami, Florida, United States + 18 more
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
NCT07213791 · Ovarian Neoplasms, Breast Neoplasms, Pancreatic Intraductal Neoplasms
RecruitingThis is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 29 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
NCT05051722 · Endometrial Cancer, Cervical Cancer, Atypical Endometrial Hyperplasia
RecruitingThe overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma. This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.
Phase—
TypeObservational
Age18 Years
WherePhoenix, Arizona, United States + 23 more
SponsorMayo Clinic
▾Tap for detailsClick for full details — eligibility, all locations, contacts Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).
PhasePhase 3
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 58 more
SponsorGOG Foundation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
NCT05879926 ·
Breast Cancer RecruitingThis Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
PhasePhase 3
TypeInterventional
Age18 Years – 60 Years
WhereBirmingham, Alabama, United States + 1248 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
NCT04633239 · Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
RecruitingThis phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 26 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
NCT06412120 ·
Ovarian Cancer RecruitingThe purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.
PhasePhase 4
TypeInterventional
Age18 Years
WhereFort Lauderdale, Florida, United States + 3 more
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
NCT05877599 ·
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma
RecruitingPhase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
PhasePhase 1
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 17 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
NCT06293898 · Endometrial Cancer, Cervical Cancer,
Ovarian Cancer RecruitingThe objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 16 more
SponsorSystImmune Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
NCT06819007 ·
Ovarian Cancer RecruitingThis clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBurbank, California, United States + 207 more
SponsorDaiichi Sankyo
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
NCT04300556 · Solid Tumor
RecruitingThe primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[OC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 57 more
SponsorEisai Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts