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Tests treatment safety and results for Colorectal Cancer Metastatic
Official title Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06008119
What this study is testing
What is Tunlametinib plus Vemurafenib?
Tunlametinib plus Vemurafenib is an investigational medicine, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, open-label, Phase 3 study
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
- Male or female patients with 18 to 70 years of age at time of informed consent;
- Histological or cytologically confirmed metastatic CRC
- Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600...
- Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for confirmatory central...
You likely can't join if
- Exclusion Criteria:
- Prior treatment with any BRAF and MEK inhibitor;
- Known contraindication to receive the treatment of control arm (according to latest PI).
- Symptomatic brain metastasis or leptomeningeal disease
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or...
- Known history of acute or chronic pancreatitis
See the full eligibility criteria
- 1. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
- Male or female patients with 18 to 70 years of age at time of informed consent;
- Histological or cytologically confirmed metastatic CRC
- Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600 is permitted)
- Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for confirmatory central laboratory testing of BRAF mutation status.
- Progression of disease after 1 or more prior regimens in the metastatic setting
- At least 1 site of radiographically measurable disease by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
- Life expectancy ≥ 3 months;
- Can swallow the medicine,
- Adequate hematologic, renal, cardiac and liver function as defined by laboratory values performed within 7 days prior to initiation of dosing:
- Be willing and able to complete all the study procedures and follow-up examinations.
- Exclusion Criteria:
- Prior treatment with any BRAF and MEK inhibitor;
- Known contraindication to receive the treatment of control arm (according to latest PI).
- Symptomatic brain metastasis or leptomeningeal disease
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
- Known history of acute or chronic pancreatitis
- Uncontrolled GI bleeding, Dysphagia，refractory nausea, vomiting, small bowel resection or any other gastrointestinal ailment that would preclude study drug absorption.
- Serious cardiovascular disease , including uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia , deep vein thrombosis or pulmonary...
- History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
- Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular...
- Uncontrolled blood pressure despite medical treatment
- Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or...
- Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
- Anti-HIV(+) , Anti-TP( +); Active hepatitis B or hepatitis C infection …….
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.