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MSI-H Colorectal Cancer clinical trials

View clinical trials related to MSI-H Colorectal Cancer.

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NCT ID: NCT06414304 Recruiting - Cancer Clinical Trials

Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy

BLOOMSI
Start date: June 1, 2022
Phase:
Study type: Observational

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. The success of the CheckMate 142 and KEYNOTE-177 clinical trials has shifted the treatment paradigm of the MSI/dMMR CRC, which has led to the adoption of immune checkpoint inhibitors (ICI) by international treatment standards. However, despite the encouraging effects of ICI, up to 30% of patients are resistant to treatment and exhibit rapid disease progression shortly after starting ICI. On the other hand, around 30% of patients treated with ICI demonstrate prolonged responses to the treatment with a duration of response of over 40 months. Furthermore, for ~10% of patients, treatment with ICI results in pseudo-progression - a phenomenon of a short-term increase followed by the decrease of the tumor volume. Currently, the mechanisms and biomarkers associated with the response or resistance to ICI in MSI-positive CRC are largely unknown. Select studies suggest that BRAF mutations (specifically, BRAF p.V600E) might negatively affect the patients' progression-free survival following ICI, however, these data are premature. The primary hypothesis is that the clonal heterogeneity and the evolution of MSI status of MSI-positive CRC will play a role in the development of ICI treatment resistance. The primary objective of the study is to investigate the dynamics of MSI status in serial liquid biopsy samples from patients with MSI-positive tumors receiving ICI.

NCT ID: NCT06006923 Not yet recruiting - Clinical trials for MSI-H Colorectal Cancer

Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer

Start date: May 2024
Phase: Phase 2
Study type: Interventional

This is a trial of Regorafenib in combination with pembrolizumab for patients with MSI-H colorectal cancer consisting of lead-in phase examining preliminary efficacy and safety, followed by a randomized phase to further examine efficacy.

NCT ID: NCT05871567 Completed - Clinical trials for MSI-H Colorectal Cancer

Predictive Value of DNA Mismatch Repair System in Colorectal Cancers

DNAMMR
Start date: January 1, 2014
Phase:
Study type: Observational [Patient Registry]

- 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 conversely reveals excellent results to immunotherapy. - Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone. - On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment. - Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.

NCT ID: NCT05841134 Not yet recruiting - Capecitabine Clinical Trials

Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

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 MSI-H/dMMR Patient efficacy and safety.

NCT ID: NCT05714553 Recruiting - Gastric Cancer Clinical Trials

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours

Start date: March 8, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with different tumour types. Each module is designed to evaluate a different NUC-3373 combination and consists of a dose-validation phase (Phase Ib) and a dose-expansion phase (Phase II). Phase Ib of each module will determine the safety and tolerability of the combinations for further clinical evaluation in Phase II. Approximately 6-20 evaluable patients will be enrolled in the Phase Ib stage of each module to determine safety, tolerability, and preliminary efficacy of NUC-3373 in combination with other agents. Each module will then move into Phase II to enable a further assessment of safety and efficacy in approximately 20-40 patients. Module 1 will assess NUC-3373 + leucovorin (LV) in combination with pembrolizumab for the treatment of patients with advanced/metastatic solid tumours who have progressed on ≤2 prior therapies for metastatic disease, that may have included 1 prior immunotherapy-containing regimen (either monotherapy or in combination with chemotherapy) or who have not progressed but where addition of NUC-3373 + LV to standard pembrolizumab monotherapy may be appropriate (e.g., patients who could not tolerate post- immuno-oncology (IO) standard of care therapy). Module 2 will assess NUC-3373 + LV in combination with docetaxel for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease. The opening of each module will be at the discretion of the Sponsor. Further modules may be added as non-clinical and clinical data become available to support additional NUC-3373 combinations and tumour types.

NCT ID: NCT05429866 Recruiting - Breast Cancer Clinical Trials

Immunological Variables Associated to ICI Toxicity in Cancer Patients

Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy. For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points: - Early (4-6 weeks after treatment start) - Midtime (8-11 weeks after treatment start) - Late (13-18 weeks after treatment start) - At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points: - For the 1st time of any grade 1 or 2 irAE if the subject developed it. - For the 1st time of any grade 3 or 4 irAE if the subject developed it.

NCT ID: NCT04802876 Recruiting - Clinical trials for Hepatocellular Carcinoma

Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors

ACROPOLI
Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04730544 Recruiting - Clinical trials for Colorectal Cancer Metastatic

Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC.

NIPISAFE
Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04440943 Completed - Breast Cancer Clinical Trials

A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

Start date: August 4, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

NCT ID: NCT04301557 Active, not recruiting - Clinical trials for MSI-H Colorectal Cancer

PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer

Start date: July 31, 2020
Phase: Phase 2
Study type: Interventional

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 unresectable locally advanced colon cancer. Thus, this study will investigate the efficacy and toxicity of combination strategy using PD1 antibody and chemoradiotherapy for dMMR/MSI-H locally advnaced colorectal cancer patients.