Clinical trials: MSI-H 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 Colorectal Cancer, Melanoma
Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors.
- Conditions
- MSI-H Colorectal Cancer, Melanoma, Anal Carcinoma, Mesothelioma
- Trial name
- ACROPOLI (NCT04802876)
- Testing
- Spartalizumab, Tislelizumab
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- SOLTI Breast Cancer Research Group
Colon Cancer, dMMR Colorectal Cancer
Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
This is a Phase II, single arm study looking at the rate of major clinical response and non-operative management in Stage II and III colon cancer after 18 weeks (up to 6 cycles) of neoadjuvant dostarlimab.
- Trial name
- NAIO (NCT05239546)
- Testing
- Dostarlimab
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- University of Iowa
Colorectal Cancer, Mismatch Repair-deficient (dMMR)
Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer
Colorectal cancer of Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) accounts for approximately 15% of all colorectal cancer patients, with a higher proportion in right colon cancer.
- Conditions
- Colorectal Cancer, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H), Neoadjuvant Therapy
- Trial name
- PICC (NCT03926338)
- Testing
- Neoadjuvant toripalimab plus celecoxib for 6 cycles, Neoadjuvant toripalimab monotherapy for 6 cycles, Neoadjuvant toripalimab plus celecoxib for 12 cycles
- Where
- China
- Volunteers
- 270 people
- Sponsor
- Sun Yat-sen University
Colo-rectal Cancer (dMMR/MSI-H CRC)
Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal Cancer
This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite…
- Trial name
- NCT07352280
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
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.
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
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.
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
MSI-H Colorectal Cancer, Tislelizumab
Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
This study is a multi-center, single-arm, open-label phase II clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (CAPOX) in stage II or III colorectal cancer with…
- Conditions
- MSI-H Colorectal Cancer, Tislelizumab, Oxaliplatin, Capecitabine
- Trial name
- NCT05841134
- Testing
- Tislelizumab
- Volunteers
- 25 people
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
Colorectal Carcinoma
Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
In this study, participants with stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal carcinoma (CRC) will be randomly assigned to receive either pembrolizumab or the Investigator's…
- Trial name
- NCT02563002
- Testing
- mFOLFOX6, FOLFIRI, Pembrolizumab
- Volunteers
- 307 people
- Sponsor
- Merck Sharp & Dohme LLC
dMMR/MSI-H-type Rectal Adenocarcinoma
The Efficacy and Safety of Neoadjuvant Therapy With Iparomlimab and Tuvonralimab in Locally Advanced MSI-H/dMMR Colorectal Cancer: An Prospective, Single-Arm Study (Neo-IT)
Immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for dMMR/MSI-H locally advanced rectal cancer.
- Trial name
- Neo-IT (NCT07160647)
- Testing
- Ipalolimab and Tovorilimab
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Sir Run Run Shaw Hospital
Microsatellite Instability High, Mismatch Repair Deficiency
Anti-PD-1 +/- RT for MSI-H Solid Tumors
To determine if the out-of-field ORR is improved with the addition of radiation therapy to anti-PD-1 for patients with MSI-H/dMMR metastatic solid tumors.
- Conditions
- Microsatellite Instability High, Mismatch Repair Deficiency, Colorectal Cancer
- Trial name
- NCT04001101
- Testing
- RT and Anti-PD-1, Anti-PD-1
- Where
- United States
- Sponsor
- University of Colorado, Denver
Immunotherapy, Adjuvant Therapy
Immunotherapy Versus Chemotherapy as Adjuvant Therapy for Colon Cancer With MSI-H or POLE/ POLD1 Mutations
This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of immunotherapy versus standard chemotherapy in patients undergoing T4NX/TXN+ colon cancer surgery with MSI-H or POLE/…
- Conditions
- Immunotherapy, Adjuvant Therapy, Colon Cancer, MSI-H
- Trial name
- NCT04969029
- Testing
- Tirelizumab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Colorectal Cancer, SGLT-2 Inhibitor
Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer
Colorectal cancer (CRC), ranking third in incidence among men and second in women globally with third-highest mortality in the US, remains a major health challenge despite multimodal therapies, particularly for advanced-stage…
- Trial name
- NCT07076823
- Testing
- Canagliflozin
- Where
- China
- Volunteers
- 15 people
- Sponsor
- West China Hospital
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
Advanced Malignancies
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.
- Trial name
- NCT03241173
- Testing
- INCAGN01949, Nivolumab, Ipilimumab
- Where
- 15 sites in United States
- Volunteers
- 52 people
- Sponsor
- Incyte Biosciences International Sàrl
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or…
- Conditions
- Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma, Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial
- Trial name
- NCT05544929
- Testing
- KFA115, pembrolizumab
- Where
- 18 sites in United States, Canada and 10 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
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