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Metastatic Colorectal Cancer - ClinicalTrials.gov

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Last Updated: 27 April 2022

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Phase II Trial of VB-111 in Combination With Nivolumab in Patients With Metastatic Colorectal Cancer (mCRC).

Objectives: To determine the best overall response in patients with refractory, metastatic CRCs, the objective is to determine the safety and tolerability of VB-111 in combination with nivolumab. Patients must have progressed on > 2 lines of standard of care chemotherapy for colorectal cancer metastatic to the liver, be intolerant of chemotherapy, or refused prior chemotherapy. The new research, which will include VB-111 and immune checkpoint inhibition in patients with metastatic CRC Treatment, will be provided in cycles consisting of VB-111 and immune checkpoint inhibition every 6 weeks in patients with metastatic CRC treatment, while nivolumab is administered every two weeks until progression or unacceptable toxicity in patients with metastatic CRC treatment.

Source link: https://clinicaltrials.gov/ct2/show/NCT04166383


The Role of Multimodality Management in Risk-Stratified Patients With Lung-Limited Metastatic Colorectal Cancer

To compare recurrence-free survival in patients with "low risk" lung-limited metastatic cancer undergoing pulmonary metastasectomy with or without perioperative chemotherapy. To determine overall survival in patients with "high risk" lung-limited mCRC receiving systemic chemotherapy with or without surgical resection, compare overall survival in patients with or without surgical resection. Patients receive standard of care chemotherapy for three months before and three months after undergoing metastasectomy in the absence of disease progression or unacceptable toxicity, according to GROUP 1A. GROUP 2 : In the absence of disease progression or unacceptable toxicity, all high risk patients receive standard of care chemotherapy for three months. Patients with progressive disease after 3 months are then randomized to one of two groups. Patients are still receiving standard of care chemotherapy for six months in the absence of disease progression or unacceptable toxicity. Patients with stable disease or radiographic response after 6 months may then progress to Group 2A.

Source link: https://clinicaltrials.gov/ct2/show/NCT03599752


Phase I/II Trial of Encorafenib, Binimetinib, and Nivolumab in Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

In patients with BRAFV600E, microsatellite stable metastatic colorectal cancer patients with encorafenib, binimetinib, and nivolumab, the overall response rate was determined during chemotherapy with encorafenib, binimetinib, and nivolumab was discussed. Patients with BRAFV600E, MSS mCRC are among the clinical and tolerability of nivolumab, encorafenib, and binimetinib. With radiographic responses, we can compare genomic and immune responses to treatment with encorafenib, binimetinib, and nivolumab. To compare location and patterns of metastatic disease with clinical outcomes, contrast-enhanced computed tomography imaging for disease burden that is not identifiable by immune-related Response Evaluation Criteria in Solid Tumors is used to determine baseline and regional distribution of metastatic disease. Patients are encorafenib orally on day 1, binimetinib PO twice daily on days 1-28, binimetinib PO twice daily on days 1-28, and nivolumab intravenously on day 1. If disease progression or recurrence occurs, treatment may be restarted outside of the clinical context.

Source link: https://clinicaltrials.gov/ct2/show/NCT04044430


Randomized, Double-Blind, Phase II Trial of Vitamin D Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer

When given in combination with standard therapy for metastatic colorectal cancer in combination with standard therapy, the investigators are comparing standard and higher dose Vitamin D therapy. Vitamin D Cycle 1: You will take two capsules of Vitamin D every day. Participants in Arm A have been randomly selected to Arm A will receive one capsule of Vitamin D with 400 IU and one capsule with placebo so that neither you nor your doctor will know which group you have been assigned to. Participants in both Arms A and B will receive one capsule containing 4000 IU of Vitamin D. Participants who were randomly assigned to Arm B will be provided intravenously with Vitamin D. FOLFOX and bevacizumab.

Source link: https://clinicaltrials.gov/ct2/show/NCT01516216


Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

Compared to those receiving standard chemotherapy and bevacizumab in combination with standard chemotherapy and bevacizumab, a comparison can be made to determine the progression-free survival of patients receiving high-dose cholerol in combination with standard chemotherapy and bevacizumab in comparison with standard chemotherapy and bevacizumab in combination with standard chemotherapy and bevacizumab. To determine the effect of patients receiving high-dose vitamin D3 in combination with standard chemotherapy + bevacizumab versus those receiving standard chemotherapy + bevacizumab in combination with standard chemotherapy + bevacizumab. To compare the overall survival of patients receiving high-dose vitamin D3 in combination with standard chemotherapy + bevacizumab versus those receiving standard chemotherapy + bevacizumab in combination with standard chemotherapy + bevacizumab. To compare and assess the risks of increasing high-dose vitamin D3 versus standard-dose vitamin D3 to chemotherapy + bevacizumab, it's easy to assess and compare the effects. In subgroups of patients classified by baseline plasma calcifediol levels, it is possible to compare the efficacy of high-dose vitamin D3 versus standard-dose vitamin D3. On days 1-14, patients were also treated with standard-dose cholecalciferol PO QD.

Source link: https://clinicaltrials.gov/ct2/show/NCT04094688


Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers

Aflibercept, in a dose of 4 mg/kg, has already been used in combination with 5-FU at the doses used in the simplified LV5FU2 trial, evaluating its combination with FOLFIRI. Without exception, it is therefore not necessary to conduct a phase I trial if you use the same doses of 5-FU without irinotecan, within the context of a drug therapy program for patients, to be managed over a long time, rather than searching for the maximum tolerated dose of the mixture. The aflibercept-LV5FU2 combination may be useful to patients who will never be resectable or operable, as well as patients for whom 5-FU monotherapy can be used to minimize the toxicities of combined chemotherapies. aflibercept was not shown in the last VELOUR trial that toxicity would have no effect on quality of life or increase the likelihood of continued progression-free survival in the arm.

Source link: https://clinicaltrials.gov/ct2/show/NCT02384759


NIVOLUMAB Plus IPILIMUMAB and TEMOZOLOMIDE in Combination in Microsatellite Stable (MSS), MGMT Silenced Metastatic Colorectal Cancer (mCRC): the MAYA Study

In 10% of heavily pregnant patients with advanced CRC carrying MGMT promoter methylated tumors, TMZ produced an average objective response rate by RECIST criteria, according to previous phase II studies. However, even among mCRC patients, resistance to single agent TMZ develops quickly and almost immediately within 6 months from treatment initiation. In a subset of patients, immune checkpoint inhibitors have been shown to have long-term antitumor properties. In comparison to a substantial number of patients with melanomas, renal-cell cancers, and lung tumors who received PD-1 blockade, only 1 of 33 CRC patients responded to anti PD-1 therapy, according to early clinical research, only 1 of 33 CRC patients had a reaction to anti PD-1 therapy. In fact, mismatch repair-proficient colorectal cancers have ten to 100 times as many somatic mutations as mismatch repair-proficient colorectal cancers. On the other hand, TMZ has been shown to result in an increase in mutational load in other MGMT-deprived solid tumors such as melanoma or glioblastoma. In parallel, other studies have shown that alkylating agents' side effects can influence the immune cell compartment by selectively depleting the immune-suppressive T regulator lymphocytes and stimulating immune-reactive T cytotoxic lymphocytes and natural killers. On all of the above topics, the investigators believe that treatment of microsatellite stable MGMT hypermethylated CRCs with alkylating agents may alter the tumor genetic landscape by increasing the tumor genetic burden and eventually increasing the incidence of cancer neoantigens and immunogenicity. TMZ therapy can also modify the immune cell repertoire favoring T cell activation, which favors T cell activation.

Source link: https://clinicaltrials.gov/ct2/show/NCT03832621

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions