Clinical trials: Microsatellite Instability-High Colorectal Cancer
- Condition Microsatellite Instability-High Colorectal Cancer
- Funder type Industry (pharma, biotech, devices)
Advanced Solid Tumors, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC
- Trial name
- NCT04272034
- Testing
- INCB099318
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Incyte Corporation
Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in…
- Conditions
- Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Colorectal Cancer
- Trial name
- NCT07262619
- Testing
- EIK1005, pembrolizumab (KEYTRUDA® )
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 160 people
- Sponsor
- Eikon Therapeutics
Metastatic Colorectal Cancer
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High…
- Trial name
- NCT05652894
- Testing
- HX008(Pucotenlimab), Investigator's Choice Chemotherapy
- Where
- 63 sites in China
- Volunteers
- 190 people
- Sponsor
- Taizhou Hanzhong biomedical co. LTD
Colorectal Cancer, Colorectal Cancer Metastatic
Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy
Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Microsatellite instability or mismatch repair deficiency occurs in 20% of CRC, and is predominantly found in non-metastatic tumors.
- Conditions
- Colorectal Cancer, Colorectal Cancer Metastatic, MSI-H Colorectal Cancer, dMMR Colorectal Cancer
- Trial name
- BLOOMSI (NCT06414304)
- Where
- 2 sites in Russia
- Volunteers
- 30 people
- Sponsor
- OncoAtlas LLC
Colonic Neoplasms, Neoplasms, Colon
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/…
- Trial name
- NCT05855200
- Testing
- Dostarlimab, CAPEOX, FOLFOX
- Where
- 266 sites in United States, Argentina and 26 more
- Volunteers
- 892 people
- Sponsor
- GlaxoSmithKline
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.
Advanced or Metastatic Solid Tumors, Microsatellite Instability Low
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab.
- Conditions
- Advanced or Metastatic Solid Tumors, Microsatellite Instability Low, Microsatellite Instability High, Microsatellite Stable
- Trial name
- NCT05572684
- Testing
- NC410, pembrolizumab
- Where
- 17 sites in United States
- Volunteers
- 97 people
- Sponsor
- NextCure, Inc.
Neoplasms, Colorectal, Solid Tumor
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat.
- Conditions
- Neoplasms, Colorectal, Solid Tumor, Colon Cancer, Rectal Cancer
- Trial name
- SYLVER (NCT06710847)
- Testing
- GSK4418959, PD-1 inhibitor
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 14 people
- Sponsor
- GlaxoSmithKline
Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has…
- Conditions
- Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer
- Trial name
- CheckMate142 (NCT02060188)
- Testing
- Ipilimumab, Nivolumab, Cobimetinib
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 385 people
- Sponsor
- Bristol-Myers Squibb
Colorectal Cancer
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer
The main purpose of this study was to help meet the medical needs of people in China with certain types of solid tumors that have specific genetic changes called microsatellite instability-high (MSI-H) or deficient mismatch…
- Trial name
- NCT05116085
- Testing
- Tislelizumab
- Where
- 8 sites in China
- Volunteers
- 33 people
- Sponsor
- BeiGene
Advanced Solid Tumors, Breast Cancer Recurrent
First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers
The goal of this study is to identify a safe and tolerated dose of the orally administered DHX9 inhibitor ATX-559. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of…
- Conditions
- Advanced Solid Tumors, Breast Cancer Recurrent, Colorectal Cancer Metastatic, Colon Cancer
- Trial name
- NCT06625515
- Testing
- ATX-559
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Accent Therapeutics
Melanoma, Hepatocellular Carcinoma (HCC)
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.
- Conditions
- Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H)
- Trial name
- NCT05909995
- Testing
- INCB 99280 with Ipilimumab
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 8 people
- Sponsor
- Incyte Corporation
Metastatic Colorectal Cancer
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or…
- Trial name
- CheckMate 8HW (NCT04008030)
- Testing
- Ipilimumab, Oxaliplatin, Leucovorin
- Where
- 157 sites in United States, Argentina and 22 more
- Volunteers
- 839 people
- Sponsor
- Bristol-Myers Squibb
Advanced Malignancies, Metastatic Cancer
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
- Trial name
- NCT03126110
- Testing
- INCAGN01876, Nivolumab, Ipilimumab
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 145 people
- Sponsor
- Incyte Biosciences International Sàrl
Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer.
- Trial name
- NCT07412613
- Testing
- Cadonilimab (AK104), Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 386 people
- Sponsor
- Akeso
Cancer, Immunotherapy
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)
This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or…
- Conditions
- Cancer, Immunotherapy, Advanced Solid Tumors Cancer, Bladder Cancer
- Trial name
- ELEPHAS-05 (NCT07327489)
- Testing
- Biopsy
- Where
- 8 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Elephas
Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
- Conditions
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer
- Trial name
- NCT03538028
- Testing
- INCAGN02385
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Incyte Biosciences International Sàrl
Colorectal Cancer
Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients
dMMR/MSI-H colorectal cancer patients are the dominant population of immunotherapy/neoadjuvant immunotherapy, but imaging evaluation of immunotherapy efficacy is insufficient.
- Trial name
- NCT06098560
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Geneplus-Beijing Co. Ltd.
Neoplasms
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive…
- Trial name
- NCT02635672
- Testing
- VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg, Keytruda
- Where
- 16 sites in United States, Chile and 1 more
- Volunteers
- 110 people
- Sponsor
- Vincerx Pharma, Inc.
Non-small Cell Lung Cancer, Breast Cancer
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.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma
- Trial name
- NCT04440943
- Testing
- CDX-527
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celldex Therapeutics