Clinical trials: Colo-rectal Cancer (dMMR/MSI-H CRC)
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
Gastrointestinal Cancer, Colorectal (Colon or Rectal) Cancer
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers
This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with…
- Conditions
- Gastrointestinal Cancer, Colorectal (Colon or Rectal) Cancer, Stomach (Gastric) Cancer
- Trial name
- NOMIC (NCT07656740)
- Testing
- NOM, RO
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University Cancer Hospital & Institute
Colorectal Cancer, Mismatch Repair-deficient (dMMR)
Cadonilimab as Neoadjuvant Therapy in Resectable Stage II-III MSI-H/dMMR Colorectal Cancer
This study will evaluate the safety, and tolerability of Cadonilimab as neoadjuvant treatment for resectable local advanced colorectal cancer patient with dMMR/MSI-H.
- Conditions
- Colorectal Cancer, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H), Neoadjuvant Therapy
- Trial name
- MSI-H/dMMR (NCT05913570)
- Testing
- Cadonilimab (®), a PD-1/CTLA-4 bi-specific antibody
- Where
- China
- Volunteers
- 22 people
- Sponsor
- LiuYing
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
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
Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer
Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC).
- Trial name
- CORESIM (NCT06353854)
- Where
- 20 sites in France
- Volunteers
- 600 people
- Sponsor
- Federation Francophone de Cancerologie Digestive
Colorectal Cancer Not MSI-H or MMR-deficient, GIST
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial).
- Conditions
- Colorectal Cancer Not MSI-H or MMR-deficient, GIST, Oesophageal or Gastric Carcinoma, Biliary Tract Cancer
- Trial name
- REGOMUNE (NCT03475953)
- Testing
- Phase 1 : Regorafenib, Phase 1 : Avelumab, Phase 2 : Regorafenib
- Where
- 7 sites in France
- Volunteers
- 747 people
- Sponsor
- Institut Bergonié
DMMR Colorectal Cancer, Anti PD-1
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate…
- Conditions
- DMMR Colorectal Cancer, Anti PD-1, Immunotherapy
- Trial name
- NCT06262581
- Testing
- Tisleizumab(BGB-A317)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
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, 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
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
- 25 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Medicenna Therapeutics, Inc.
Immunotherapy, Cancer
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
- Conditions
- Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder
- Trial name
- ELEPHAS-02 (NCT05520099)
- Testing
- Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
- Where
- 12 sites in United States
- Volunteers
- 416 people
- Sponsor
- Elephas
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
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
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
Neoplasms
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive…
- Trial name
- NCT02635672
- Testing
- VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg, Keytruda
- Where
- 16 sites in United States, Chile and 1 more
- Volunteers
- 110 people
- Sponsor
- Vincerx Pharma, Inc.
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
DMMR Colorectal Cancer, MSI-H Colorectal Cancer
PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer
PD1 antibody is now recommended for dMMR/MSI-H metastatic colorectal cancer patients as second line. Chemoradiotherapy is standand treatment for locally advanced rectal cancer and is also recommended as an alternative choice for…
- Conditions
- DMMR Colorectal Cancer, MSI-H Colorectal Cancer, Locally Advanced Colorectal Cancer
- Trial name
- NCT04301557
- Testing
- PD-1 Antibody, Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Sun Yat-sen University
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
Metastatic Colorectal Cancer (CRC)
A Study of DES-1357 in People With Deficient Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer (mCRC)
This study is conducted sequentially in 3 parts. The primary objective for Part 1 is to determine the maximum tolerated dose of DES-1357 in participants with confirmed dMMR/MSI-H colorectal cancer (CRC).
- Trial name
- NCT07807800
- Testing
- DES-1357
- Volunteers
- 88 people
- Sponsor
- D. E. Shaw Research, LLC