Clinical trials: Microsatellite Instability-High Colorectal Cancer
Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors
This is an open-label phase I study to evaluate the safety, tolerability, and initial efficacy of JS004 injection combined with Toripalimab Injection in patients with advanced solid tumors who have failed standard therapy.
- Trial name
- NCT05427396
- Testing
- JS004, Toripalimab Injection
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Colorectal Cancer
Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin
The investigators hypothesize that atezolizumab will improve the prognosis of patients with stage III dMMR CRC ineligible for or refusing oxaliplatin-based adjuvant chemotherapy compared to SOC and that these could therefore be…
- Trial name
- ANTONIO (NCT05118724)
- Testing
- Atezolizumab, IMM-101
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- AIO-Studien-gGmbH
Neoplasms, Rectal
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior…
- Trial name
- AZUR-1 (NCT05723562)
- Testing
- Dostarlimab
- Where
- 42 sites in United States, Canada and 8 more
- Volunteers
- 154 people
- Sponsor
- GlaxoSmithKline
Multiple Cancer, Colorectal Cancer
Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC
At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment.
- Trial name
- NCT06002789
- Testing
- MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy
- Where
- China
- Volunteers
- 17 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
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
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
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study
This phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it…
- Trial name
- NCT02997228
- Testing
- Atezolizumab, Bevacizumab, Biospecimen Collection
- Where
- 445 sites in United States
- Volunteers
- 120 people
- Sponsor
- National Cancer Institute (NCI)
Colon Cancer
A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.
10%-15% of early-stage colon cancers harbour either deficient mismatch repair (dMMR), microsatellite instability high (MSI-H) is characterised by high tumour mutational burden and increased lymphocytic infiltrate.
- Trial name
- NCT05231850
- Testing
- Tislelizumab
- Volunteers
- 70 people
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
Neoplasms, Rectal
A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer
This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to…
- Trial name
- DuraSTAR (NCT07740720)
- Testing
- Dostarlimab
- Volunteers
- 90 people
- Sponsor
- GlaxoSmithKline
Thyroid Cancer, Renal Cell Carcinoma
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Conditions
- Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Trial name
- NCT04234113
- Testing
- Nanrilkefusp alfa, Pembrolizumab
- Where
- 12 sites in United States, Czechia and 2 more
- Volunteers
- 115 people
- Sponsor
- SOTIO Biotech AG
Gastrointestinal Cancers, Gastrointestinal Cancers - Stomach
Safety and Efficacy of NOM and OPFS Versus RO for dMMR/MSI-H or POLE-Mutated Gastrointestinal Cancers
Purpose: The purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch…
- Conditions
- Gastrointestinal Cancers, Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal, Gastrointestinal Cancers - Anus
- Trial name
- NOR-MP (NCT07642323)
- Testing
- NOM/OPFS
- Volunteers
- 22 people
- Sponsor
- Peking University Cancer Hospital & Institute
Microsatellite-instability (MSI) High Colorectal Cancer (CRC), Endometrial Cancer
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers
The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.
- Conditions
- Microsatellite-instability (MSI) High Colorectal Cancer (CRC), Endometrial Cancer, Head and Neck Cancer, Hepatocellular Carcinoma (HCC)
- Trial name
- NCT02178722
- Testing
- MK-3475, INCB024360
- Where
- 24 sites in United States
- Volunteers
- 444 people
- Sponsor
- Incyte Corporation
MSI-H Advanced Colorectal Cancer
PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Advanced Colorectal Cancer
MSI-H is a biomarker for solid tumors benefiting from immunotherapy. Recent clinical studies have confirmed that PD-1 inhibitors have a good effect on MSI-H advanced colorectal cancer for first- or second-line treatment.
- Trial name
- NCT05035381
- Testing
- Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Colorectal Cancer (MSI-H), Postoperative Delirium (POD)
POD Risk for Colorectal Cancer Surgery
Postoperative delirium is a common complication after colorectal cancer surgery that hinders recovery. This observational study hypothesizes that a simple, practical risk tool can be developed by combining preoperative clinical…
- Trial name
- NCT07597330
- Where
- China
- Volunteers
- 590 people
- Sponsor
- LanZhou University
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
Colorectal Cancer Stage IV, Mismatch Repair-deficient (dMMR)
Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer
KEYNOTE-177 is currently the only randomized controlled phase III clinical trial evaluating the efficacy and safety of pembrolizumab versus standard chemotherapy combined with targeted first-line therapy for dMMR/MSI-H metastatic…
- Conditions
- Colorectal Cancer Stage IV, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H)
- Trial name
- NCT05426005
- Testing
- Cadonilimab
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Sun Yat-sen University
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
Colorectal Cancer (MSI-H), Microplastic Exposure
Microplastics in Paraneoplastic and Intratumoral for Colorectal Cancer
The objective of this study is to identify and characterize microplastics present in peritumoral and intratumoral tissues of colorectal cancer patients, and to investigate their associations with gut microbiome composition and…
- Trial name
- NCT07063550
- Testing
- exposure to microplastic
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Dong Peng
dMMR Colorectal Cancer
Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer
This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment.
- Trial name
- NCT05815290
- Testing
- Cadonilimab
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
DMMR Colorectal Cancer, Colon Cancer Stage I
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer
The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab.
- Conditions
- DMMR Colorectal Cancer, Colon Cancer Stage I, Colon Cancer Stage II/III, Pembrolizumab
- Trial name
- RESET C2 (NCT07409844)
- Testing
- 1 Cycle of Pembrolizumab, 2 Cycles of Pembrolizumab, 3 Cycles of Pembrolizumab
- Where
- Denmark
- Volunteers
- 152 people
- Sponsor
- Ismail Gögenur