Clinical trials: Microsatellite Instability-High Colorectal Cancer
POLE Exonuclease Mutant Colon Cancer, Microsatellite Instability
Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer
The purpose of this study is to determine if dMMR and/or POLE exonuclease domain mutant stage III colon cancer patients gain clinical benefit (i.e.
- Conditions
- POLE Exonuclease Mutant Colon Cancer, Microsatellite Instability, Stage III Colon Cancer
- Trial name
- POLEM (NCT03827044)
- Testing
- Avelumab
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Neoplasms, Colorectal, Neoplasms
A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 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.
- Trial name
- NCT07213609
- Testing
- GSK5460025
- Where
- 27 sites in United States, Canada and 7 more
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Colorectal Cancer (MSI-H), Colorectal Cancer (CRC)
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer
Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.
- Trial name
- NIVO1002024 (NCT07523763)
- Testing
- Nivolumab, Pembrolizumab
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Colorectal Cancer
A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer
To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker…
- Trial name
- NCT04118933
- Testing
- JS001
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Xu jianmin
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
Advanced Solid Tumor, Metastatic Solid Tumor
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Endometrial Cancer, MSI-H Cancer
- Trial name
- NCT06974110
- Testing
- MOMA-341, Irinotecan, Immunotherapy
- Where
- 15 sites in United States, Australia
- Volunteers
- 132 people
- Sponsor
- MOMA Therapeutics
Renal Cell Carcinoma, Non Small Cell Lung Cancer
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.
- Conditions
- Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Colo-rectal Cancer (dMMR/MSI-H CRC)
- Trial name
- PSI-Immune (NCT07223424)
- Testing
- nivolumab, pembrolizumab
- Where
- United States
- Volunteers
- 880 people
- Sponsor
- Diwakar Davar
Malignancy, Malignant Neoplasm
DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition
This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer…
- Conditions
- Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type
- Trial name
- DETERMINE (NCT05770102)
- Testing
- Atezolizumab
- Where
- 27 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Cancer Research UK
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
Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer
Liver metastasis is the main cause of death in patients with colorectal cancer. The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients.
- Trial name
- NCT06423937
- Testing
- combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Fudan University
Rectal Cancer
Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer
Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC) , more than fifty percent of dMMR/MSI-H CRC patients might get…
- Trial name
- BASKET (NCT04643041)
- Testing
- watch and wait
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
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
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
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
MMR-D/MSI-H Colorectal Cancers
Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers
The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC.
- Trial name
- NCT06365970
- Testing
- Niraparib, Dostarlimab
- Sponsor
- Ibrahim Halil Sahin
Colorectal Cancer
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008).
The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
- Trial name
- NCT04895722
- Testing
- Pembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab
- Where
- 109 sites in United States, Belgium and 20 more
- Volunteers
- 302 people
- Sponsor
- Merck Sharp & Dohme LLC
Colo-rectal Cancer, MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC
This study is a prospective, open-label, dual-arm exploratory Phase II clinical trial designed to assess the efficacy and safety of cadonilimab combined with anti-angiogenic agents in patients with dMMR/MSI-H recurrent or…
- Trial name
- NCT07003022
- Testing
- cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib.
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Fudan University
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)
Rectal Neoplasms
Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer
Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer mortality in the United States.
- Trial name
- NCT04357587
- Testing
- Pembrolizumab, External beam radiation, Capecitabine
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Case Comprehensive Cancer Center
Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR)…
- Trial name
- NCT07128355
- Testing
- Stereotactic Body Radiation Therapy (SBRT), Botensilimab, Balstilimab
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Massachusetts General Hospital