Clinical trials: MSI-H/dMMR Colorectal Cancer
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 (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
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, Microsatellite Instability High
Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer
This open-label phase III trial investigates the efficacy of two cycles of PD-1 blockade (Tislelizumab) as adjuvant therapy to see how it works compared with standard of care (SOC) in treating patients with stage II dMMR/MSI-H…
- Trial name
- SMALLER (NCT06520683)
- Testing
- Tislelizumab, Adjuvant chemotherapy
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sun Yat-sen University
Localized Colon Carcinoma, Stage IIB Colon Cancer AJCC v8
Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.
- Conditions
- Localized Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8
- Trial name
- NCT07140679
- Testing
- Biopsy Procedure, Biospecimen Collection, Colonoscopy
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory University
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
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
Unresectable Colorectal Cancer, Metastatic Colorectal Cancer (CRC)
QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC
This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high…
- Conditions
- Unresectable Colorectal Cancer, Metastatic Colorectal Cancer (CRC), MSI-H/dMMR Colorectal Cancer
- Trial name
- NCT07009145
- Testing
- QL1706, Bevacizumab
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Qianfoshan Hospital
Colorectal Cancer
Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients
dMMR/MSI-H colorectal cancer patients are the dominant population of immunotherapy/neoadjuvant immunotherapy, but imaging evaluation of immunotherapy efficacy is insufficient.
- Trial name
- NCT06098560
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Geneplus-Beijing Co. Ltd.
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
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
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.
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
Non-Small Cell Lung Cancer, Small Cell Lung Cancer
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors.
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma
- Trial name
- NCT03228667
- Testing
- N-803 + Pembrolizumab, N-803 + Nivolumab, N-803 + Atezolizumab
- Where
- 35 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
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
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
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
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
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
Melanoma, Hepatocellular Carcinoma (HCC)
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.
- Conditions
- Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H)
- Trial name
- NCT05909995
- Testing
- INCB 99280 with Ipilimumab
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 8 people
- Sponsor
- Incyte Corporation