Clinical trials: Microsatellite Instability-High Colorectal Cancer
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
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
The goal of this phase 2 clinical trial is to learn whether a medicine called cadonilimab (AK104) can safely and effectively treat certain stomach and colon cancers when it is given before and after surgery.
- Trial name
- NCT04556253
- Testing
- AK104, Radical Surgery
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Peking University
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
Tislelizumab in People With Colorectal Cancer
The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug.
- Trial name
- NCT06529523
- Testing
- Tislelizumab
- Where
- 3 sites in United States, Nigeria
- Volunteers
- 40 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
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
Metastatic Colorectal Cancer
Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651)
The purpose of this study is to determine safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab plus binimetinib (Cohort A), pembrolizumab plus…
- Trial name
- NCT03374254
- Testing
- Pembrolizumab, Binimetinib, Oxaliplatin
- Where
- 14 sites in United States, Canada
- Volunteers
- 116 people
- Sponsor
- Merck Sharp & Dohme LLC
Colorectal Neoplasm
Fruquitinib Combined With Camrelizumab in Non MSI-H/dMMR Refractory Colorectal Cancer
Limited agents are optional after standard first and second line treatment for mCRC. Nowadays, cancer therapy has entered the era of immunotherapy.
- Trial name
- NCT04866862
- Testing
- Combination of Fruquintinib and Camrelizumab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Metastatic Colorectal Cancer
Durvalumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer
The POLE mutations represent high somatic mutation loads in patients with colorectal cancer, especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations might be susceptible to immune checkpoint…
- Trial name
- NCT03435107
- Testing
- Durvalumab
- Where
- South Korea
- Volunteers
- 33 people
- Sponsor
- Asan Medical Center
Clinical Complete Response Rate With Negative MRD
The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring: A Single-center, Open-label, Prospective, Phase II Clinical Trial.
This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve…
- Trial name
- WINDOW (NCT06477991)
- Testing
- Tireilizumab（PD-1 inhibitor）
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Yunnan Cancer Hospital
Microsatellite Stable Colorectal Cancer, Pancreatic Cancer
Nivolumab and Ipilimumab and Radiation Therapy in MSS and MSI High Colorectal and Pancreatic Cancer
This research study is studying a combination of drugs with radiation therapy as a possible treatment for Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, or MSI High Colorectal Cancer.
- Conditions
- Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, MSI High Colorectal Cancer
- Trial name
- NCT03104439
- Testing
- Nivolumab, Ipilimumab, Radiation Therapy
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Massachusetts General 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 Cancer (MSI-H)
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer
This phase II clinical trial evaluates the efficacy and safety of three neoadjuvant regimens in patients with locally advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC): 1)…
- Trial name
- TORCH-OPTIMA (NCT07403877)
- Testing
- Nivolumab, Ipilimumab (1mg/kg), PULSAR
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Fudan University
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
Colorectal Carcinoma
PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer
In this open-label phase III study, patients with local advanced colon cancer (TanyN+ ,M0, dMMR/MSI-H, at least 10cm from the anus verge)will be scheduled to Group A: receive anti-PD-1 antibody alone (8 cycles, 200mg iv drip Q3W)…
- Trial name
- NCT05236972
- Testing
- Sintilimab, Oxaliplatin, capecitabine
- Where
- China
- Volunteers
- 323 people
- Sponsor
- Sun Yat-sen University
MSI, dMMR Colorectal Cancer
Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer
MSI is a molecular indicator of defective DNA mismatch repair (dMMR). The MSI/dMMR status is observed in all tumor types, representing notably 5% of metastatic colorectal cancers (mCRC), 25% of advanced endometrial cancer and 8%…
- Trial name
- MONAMI (NCT06152523)
- Testing
- Monalizumab/MEDI5257
- Where
- France
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally…
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
- Trial name
- NCT04751370
- Testing
- Computed Tomography, Ipilimumab, Magnetic Resonance Imaging
- Where
- 213 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Cancer Institute (NCI)
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
Colorectal Cancer Metastatic, Mismatch Repair Deficiency
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5% in metastatic colorectal cancer (mCRC).
- Conditions
- Colorectal Cancer Metastatic, Mismatch Repair Deficiency, Microsatellite Instability High
- Trial name
- NCT04482608
- Where
- China
- Volunteers
- 671 people
- Sponsor
- Sun Yat-sen University
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