Clinical trials: sponsored by Natera, Inc.
Lung Transplantation
Trifecta-Lung cfDNA-MMDx Study
Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung…
- Trial name
- NCT05837663
- Where
- 19 sites in United States, Australia and 3 more
- Volunteers
- 600 people
- Sponsor
- University of Alberta
Bladder Cancer, Urothelial Carcinoma
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
RETAIN-3 is a phase II study in patients with cT2-T3N0M0 muscle-invasive urothelial carcinoma of the bladder. Participants will receive neoadjuvant enfortumab vedotin and pembrolizumab followed by clinical and biomarker-based…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma, Muscle-invasive Bladder Urothelial Carcinoma
- Trial name
- RETAIN-3 (NCT07908979)
- Testing
- Enfortumab vedotin, Pembrolizumab, Cisplatin
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Fox Chase Cancer Center
Large B-cell Lymphoma
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have…
- Trial name
- ALPHA3 (NCT06500273)
- Testing
- cemacabtagene ansegedleucel, Fludarabine, Cyclophosphamide
- Where
- 86 sites in United States, Australia and 2 more
- Volunteers
- 250 people
- Sponsor
- Allogene Therapeutics
Breast Cancer
Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer
The SAFE-DE study investigates whether circulating tumour DNA (ctDNA) testing can guide adjuvant treatment decisions in patients with stage I breast cancer, identifying those who may be able to avoid chemotherapy after surgery.
- Trial name
- Safe-De (NCT05058183)
- Testing
- ctDNA
- Where
- 13 sites in United Kingdom
- Volunteers
- 800 people
- Sponsor
- Royal Marsden NHS Foundation Trust
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI…
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Carcinoma), NSCLC
- Trial name
- SIGNAL-IO 301 (NCT07689812)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 920 people
- Sponsor
- Natera, Inc.
Pancreas Cancer
ctDNA Assay in Patients With Resectable Pancreatic Cancer
The purpose of this study is to determine the proportion of positive ctDNA -freely circulating tumor DNA fragments found in the blood plasma- in patients with pancreatic cancer and to better understand the relationship between…
- Trial name
- OU-SCC-ctDNA (NCT05052671)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Oklahoma
Hereditary Cancer Syndrome
Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening
The investigators hypothesize that preconception and pregnancy may be a feasible and effective time to offer inherited cancer risk screening.
- Trial name
- FOCUS (NCT07195071)
- Testing
- Natera empower comprehensive hereditary cancer panel, Obstetrical carrier screening
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Hodgkin Lymphoma, Adult, Refractory Hodgkin Lymphoma
ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with…
- Conditions
- Hodgkin Lymphoma, Adult, Refractory Hodgkin Lymphoma, Classic Hodgkin Lymphoma
- Trial name
- NCT07021989
- Testing
- Pembrolizumab, Non-investigational, involved site radiotherapy (ISRT), Gemcitabine
- Where
- 6 sites in United States
- Volunteers
- 38 people
- Sponsor
- Michael Spinner, MD
ER-positive Breast Cancer, HER2-negative Breast Cancer
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse.
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
- Trial name
- TREAT ctDNA (NCT05512364)
- Testing
- Elacestrant, Tamoxifen, Letrozole 2.5mg
- Where
- 113 sites in Belgium, Cyprus and 10 more
- Volunteers
- 220 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Colon Adenocarcinoma, Rectal Adenocarcinoma
Evaluating Novel Therapies in ctDNA Positive GI Cancers
This study is a non-randomized, open-label, multi-cohort, multi-site, pilot feasibility therapeutic trial. The study will enroll 20 patients across 4 cohorts (CRC, gastric, PDAC, and HCC/intra-hepatic-/extra-hepatic-, gall…
- Conditions
- Colon Adenocarcinoma, Rectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma
- Trial name
- MRD-GI (NCT05482516)
- Testing
- Atezolizumab, Bevacizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Heart Transplant Rejection
Trifecta-Heart cfDNA-MMDx Study
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.
- Trial name
- NCT04707872
- Testing
- MMDx diagnostic test, Prospera, HLA antibody
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 300 people
- Sponsor
- University of Alberta
Gastroesophageal Adenocarcinoma
AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
This study will test a new personalized treatment approach for patients with stomach or esophageal cancer. It will take place in two stages and aims to find the best combination of chemotherapy, immunotherapy, and targeted drugs…
- Trial name
- AACR-ADOPT-GEA (NCT07290985)
- Testing
- Tislelizumab, Leucovorin, Oxaliplatin
- Where
- 4 sites in United States, Canada
- Volunteers
- 242 people
- Sponsor
- American Association for Cancer Research
Muscle-invasive Bladder Cancer
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are…
- Trial name
- IMvigor011 (NCT04660344)
- Testing
- Atezolizumab, Signatera
- Where
- 141 sites in United States, Argentina and 21 more
- Volunteers
- 761 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease.
- Conditions
- Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma, Melanoma, Non-small Cell Lung Cancer
- Trial name
- NCT06529822
- Testing
- Synthetic long peptide personalized cancer vaccine, Poly ICLC, Signatera or Altera testing
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Washington University School of Medicine
Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the…
- Conditions
- Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8
- Trial name
- NCT05081024
- Testing
- Biopsy, Biospecimen Collection, Electronic Health Record Review
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- OHSU Knight Cancer Institute
Stage III Colon Cancer
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
- Trial name
- CIRCULATE-US (NCT05174169)
- Testing
- Signatera test, mFOLFOX6 3-6 month, CAPOX 3 month
- Where
- 1,077 sites in United States, Canada and 1 more
- Volunteers
- 1,912 people
- Sponsor
- NRG Oncology
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or…
- Conditions
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Lymphoma, Lymphoma, B-Cell
- Trial name
- TPG (NCT07502872)
- Testing
- Tafasitamab, Polatuzumab vedotin, Glofitamab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Brown University
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Vanishing Twin, Trisomy 21
Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions…
- Conditions
- Vanishing Twin, Trisomy 21, Trisomy 13, Trisomy 18
- Trial name
- VANISH (NCT05004337)
- Where
- 21 sites in United States
- Volunteers
- 136 people
- Sponsor
- Natera, Inc.