Clinical trials: Microsatellite Instability-High Colorectal Cancer
Colorectal Cancer Metastatic, MSI-H Colorectal Cancer
Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC.
NIPISAFE is open-label, phase II study to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR metastatic colorectal cancer patients.
- Trial name
- NIPISAFE (NCT04730544)
- Testing
- Nivolumab 480mg + Ipilimumab, Nivolumab 240 mg + Ipilimumab
- Where
- 19 sites in France
- Volunteers
- 96 people
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
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.
Advanced Solid Tumors, Breast Cancer Recurrent
First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers
The goal of this study is to identify a safe and tolerated dose of the orally administered DHX9 inhibitor ATX-559. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of…
- Conditions
- Advanced Solid Tumors, Breast Cancer Recurrent, Colorectal Cancer Metastatic, Colon Cancer
- Trial name
- NCT06625515
- Testing
- ATX-559
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Accent Therapeutics
Colon Cancer
A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.
10%-15% of early-stage colon cancers harbour either deficient mismatch repair (dMMR), microsatellite instability high (MSI-H) is characterised by high tumour mutational burden and increased lymphocytic infiltrate.
- Trial name
- NCT05231850
- Testing
- Tislelizumab
- Volunteers
- 70 people
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
Colorectal Cancer (MSI-H), Anxiety
Impact of Anxiety-Sleep Symptom Cluster on Immune Function and Quality of Life in Colorectal Cancer
This prospective observational study investigates the impact of the anxiety-sleep disturbance symptom cluster on cellular immune function and quality of life in colorectal cancer (CRC) patients undergoing chemotherapy.
- Trial name
- NCT07234682
- Testing
- standard-of-care chemotherapy
- Where
- China
- Volunteers
- 103 people
- Sponsor
- Hebei Provincial Hospital of Traditional Chinese Medicine
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
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
MSI-H Colorectal Cancer
Predictive Value of DNA Mismatch Repair System in Colorectal Cancers
Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs). Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and…
- Trial name
- DNAMMR (NCT05871567)
- Testing
- colorectal resection
- Volunteers
- 403 people
- Sponsor
- University of Campania Luigi Vanvitelli
Solid Tumor, Adult, HCC - Hepatocellular Carcinoma
Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors
INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with…
- Conditions
- Solid Tumor, Adult, HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Pancreatic Adenocarcinoma
- Trial name
- NCT05651022
- Testing
- Decoy20, Tislelizumab
- Where
- 12 sites in United States
- Volunteers
- 120 people
- Sponsor
- Indaptus Therapeutics, Inc
Gastric Cancer, Colon Cancer
Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair…
- Conditions
- Gastric Cancer, Colon Cancer, MSI-H, DMMR Cancer
- Trial name
- NCT06580574
- Testing
- PD1/PDL1 antibody monotherapy, up to 24 weeks, Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks, Radical surgery
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Peking 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.
Immune-related Adverse Event, Neoadjuvant Therapy
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer
This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer.
- Conditions
- Immune-related Adverse Event, Neoadjuvant Therapy, dMMR Colorectal Cancer
- Trial name
- NCT06613165
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xijing Hospital
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
Metastatic Colorectal Cancer
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: is metastatic (spread to other parts of the…
- Trial name
- SEAMARK (NCT05217446)
- Testing
- Encorafenib, Cetuximab, Pembrolizumab
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 108 people
- Sponsor
- Pfizer
Colorectal Cancer (MSI-H), Microplastic Exposure
Microplastics in Paraneoplastic and Intratumoral for Colorectal Cancer
The objective of this study is to identify and characterize microplastics present in peritumoral and intratumoral tissues of colorectal cancer patients, and to investigate their associations with gut microbiome composition and…
- Trial name
- NCT07063550
- Testing
- exposure to microplastic
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Dong Peng
Metastatic Colorectal Cancer
Avelumab 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
- NCT03150706
- Testing
- Avelumab
- Where
- South Korea
- Volunteers
- 33 people
- Sponsor
- Asan Medical Center
Neoplasms, Colorectal, Solid Tumor
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 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.
- Conditions
- Neoplasms, Colorectal, Solid Tumor, Colon Cancer, Rectal Cancer
- Trial name
- SYLVER (NCT06710847)
- Testing
- GSK4418959, PD-1 inhibitor
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 14 people
- Sponsor
- GlaxoSmithKline
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
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
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