Clinical trials: MSI-H/dMMR Colorectal Cancer
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
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
Colorectal Cancer
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
- Trial name
- NCT06948448
- Testing
- ONO-4578, Opdivo®, Oxaliplatin
- Where
- 39 sites in United States, Canada and 4 more
- Volunteers
- 144 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
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
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
Neoplasms, Rectal
A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have…
- Trial name
- China AZUR-1 (NCT06640049)
- Testing
- Dostarlimab
- Where
- 9 sites in China
- Volunteers
- 23 people
- Sponsor
- GlaxoSmithKline
Colorectal Cancer
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or…
- Trial name
- NCT04258111
- Testing
- IBI310 (anti-CTLA-4 antibody), Sintilimab(anti-PD-1 antibody)
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Cancer, Colorectal Cancer
FOG-001 in Locally Advanced or Metastatic Solid Tumors
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).
- Conditions
- Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor
- Trial name
- NCT05919264
- Testing
- FOG-001, mFOLFOX-6, Nivolumab
- Where
- 33 sites in United States, Australia
- Volunteers
- 619 people
- Sponsor
- Parabilis Medicines, Inc.
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.
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed…
- Conditions
- Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer
- Trial name
- NCT06047379
- Testing
- NEO212 Oral Capsule, Ipilimumab, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Neonc Technologies, Inc.
Advanced Solid Tumor, Unresectable Solid Tumor
A Beta-only IL-2 ImmunoTherapY Study
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a…
- Conditions
- Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer
- Trial name
- ABILITY-1 (NCT05086692)
- Testing
- MDNA11, Pembrolizumab (KEYTRUDA®)
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Medicenna Therapeutics, Inc.
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, 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
- 35 sites in United States, Australia and 12 more
- Volunteers
- 160 people
- Sponsor
- Eikon Therapeutics
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
Metastatic Colorectal Cancer
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: is metastatic (spread to other parts of the…
- Trial name
- SEAMARK (NCT05217446)
- Testing
- Encorafenib, Cetuximab, Pembrolizumab
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 108 people
- Sponsor
- Pfizer
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
Neoplasm Metastasis
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
- Trial name
- NCT04458259
- Testing
- PF-07265807, Sasanlimab, Axitinib
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 88 people
- Sponsor
- Pfizer
MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan…
- Trial name
- NCT05838768
- Testing
- HRO761, pembrolizumab, irinotecan
- Where
- 28 sites in United States, Belgium and 13 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Colorectal Neoplasms
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment.
- Trial name
- NCT05239741
- Testing
- Pembrolizumab, Oxaliplatin, Leucovorin
- Where
- 32 sites in China
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC