Clinical trials: MSI-H/dMMR Rectal Cancer
Advanced Solid Tumors, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC
- Trial name
- NCT04272034
- Testing
- INCB099318
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Incyte Corporation
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
Anti-PD-1 Antibody, Radiotherapy
Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer
This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch…
- Conditions
- Anti-PD-1 Antibody, Radiotherapy, Rectal Cancer, MSI-H
- Trial name
- NCT04636008
- Testing
- Sintilimab, Hypofractionated Radiotherapy
- Where
- China
- Volunteers
- 20 people
- Sponsor
- West China Hospital
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
Neoplasms, Rectal
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior…
- Trial name
- AZUR-1 (NCT05723562)
- Testing
- Dostarlimab
- Where
- 42 sites in United States, Canada and 8 more
- Volunteers
- 154 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
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, Microsatellite Instability High
PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMR/MSI-H Colorectal Cancer
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 inhibitors (Camrelizumab) plus VEGF inhibitor (Apatinib) for dMMR/MSI-H colorectal cancer staged as locally advanced (cT3-4N+/-M0…
- Trial name
- NCT04715633
- Testing
- PD-1 inhibitor plus VEGF inhibitors
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Sun Yat-sen University
Colorectal Cancer
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
- Trial name
- NCT06948448
- Testing
- ONO-4578, Opdivo®, Oxaliplatin
- Where
- 39 sites in United States, Canada and 4 more
- Volunteers
- 144 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
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
Breast Cancer, Colorectal Cancer
A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
ATRC-101-A01 is a Phase 1b, open-label dose escalation and expansion trial of ATRC-101, an engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally occurring human antibody.
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT04244552
- Testing
- ATRC-101, Pembrolizumab, Pegylated liposomal doxorubicin (PLD)
- Where
- 19 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atreca, Inc.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI…
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Carcinoma), NSCLC
- Trial name
- SIGNAL-IO 301 (NCT07689812)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 920 people
- Sponsor
- Natera, Inc.
Breast Cancer (Triple Negative Breast Cancer (TNBC)), Renal Cell Carcinoma (Kidney Cancer)
Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells.
- Conditions
- Breast Cancer (Triple Negative Breast Cancer (TNBC)), Renal Cell Carcinoma (Kidney Cancer), Melanoma (Skin Cancer), Non-Small Cell Lung Cancer
- Trial name
- NCT07555210
- Testing
- Dual-Energy X-ray Absorptiometry (DXA), High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Jessica Mezzanotte Sharpe
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
Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally…
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
- Trial name
- NCT04751370
- Testing
- Computed Tomography, Ipilimumab, Magnetic Resonance Imaging
- Where
- 213 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Cancer Institute (NCI)
Colorectal Cancer
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer
The main purpose of this study was to help meet the medical needs of people in China with certain types of solid tumors that have specific genetic changes called microsatellite instability-high (MSI-H) or deficient mismatch…
- Trial name
- NCT05116085
- Testing
- Tislelizumab
- Where
- 8 sites in China
- Volunteers
- 33 people
- Sponsor
- BeiGene
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
This is a single-arm, multicenter phase II clinical study. The aim is to evaluate the safety, tolerability, and anti-tumor activities of AK104(a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced gastric…
- Trial name
- NCT04556253
- Testing
- AK104
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Peking University
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
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.
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