Your session is about to expire
← Back to Search
Checkpoint Inhibitor
SX-682 + Nivolumab for Colorectal Cancer
Phase 1 & 2
Recruiting
Led By Alisha Bent, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum that is metastatic or unresectable
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of SX-682 given alone or with nivolumab for colorectal cancer that has spread or can't be removed by surgery.
Who is the study for?
This trial is for adults with RAS-mutated, MSS colorectal cancer that's spread or can't be surgically removed. They must have tried at least two prior treatments and have a life expectancy of at least 12 weeks. Participants need measurable disease, adequate organ function, and no serious medical conditions or active infections like tuberculosis or hepatitis.Check my eligibility
What is being tested?
The STOPTRAFFIC-1 trial is testing the safety and optimal dose of SX-682 alone and combined with nivolumab in advanced colorectal cancer patients. SX-682 blocks enzymes needed for tumor growth while nivolumab boosts the immune system to fight cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, fatigue, blood disorders, increased risk of infection, heart issues like irregular heartbeat or chest pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer in the colon or rectum cannot be removed by surgery and has spread.
Select...
I am fully active or can carry out light work.
Select...
I have a tissue sample from my cancer available for testing.
Select...
My bilirubin levels are below 1.5 mg/dL, or below 3.0 mg/dL if I have Gilbert's syndrome.
Select...
My tumor has RAS mutation and is stable in DNA repair, confirmed by specific tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Overall response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Biomarker analysis
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SX-682, nivolumab)Experimental Treatment2 Interventions
MONOTHERAPY STAGE: Patients receive SX-682 orally PO BID on days 1-21 in the absence of disease progression or unacceptable toxicity.
COMBINATION STAGE: Patients receive SX-682 PO BID on days 1-56 and nivolumab IV over 30 minutes on days 1 and 29. Treatment repeat every 56 days weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,011 Total Patients Enrolled
Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
754 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,423 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken experimental drugs or high-dose immune-suppressing meds in the last 28 days.My blood clotting test results are normal or controlled by medication.My cancer in the colon or rectum cannot be removed by surgery and has spread.I finished my radiotherapy at least 2 weeks ago.I am fully active or can carry out light work.I have active tuberculosis.I have previously been treated with drugs that boost the immune system to fight my colorectal cancer.I haven't taken herbal supplements or traditional medicines in the last 2 weeks.After you agree to participate in the study and give permission to access your medical records, you will be evaluated to see if you meet the requirements to participate. This will happen within 28 days before receiving the study drug. Additional criteria for inclusion will be checked during this evaluation.I am on high-dose steroids or other immune-weakening drugs, not for asthma or skin issues.I have an autoimmune disease but it's under control or not expected to worsen.I have signed all required consent forms for the study and tissue analysis.I am a woman who can have children and will use birth control during and 5 months after the study.My heart's electrical activity shows a longer than normal pause.I am not taking drugs that affect heart rhythm.I've had at least two treatments for my advanced colorectal cancer, including specific chemotherapy.I have a tissue sample from my cancer available for testing.I am a man and will use highly effective birth control during and 6 months after the study.I have serious heart or blood vessel problems that affect my daily life.I have lung inflammation that is not caused by an infection.My brain cancer has been stable for 8 weeks, and I'm not on high-dose steroids.I haven't had major surgery within the last 4 weeks, except for a diagnostic biopsy.I have not received a live-virus vaccine in the last 30 days.I haven't had cancer treatment in the last 21 days, except for palliative care.I have lung disease or had lung inflammation treated with steroids.My hemoglobin level is at least 9.0 g/dL, possibly after a transfusion.I am a woman under 62 and have a test showing my FSH level is 40 or higher, confirming I am postmenopausal.I haven't had any cancer except for certain skin, bladder, prostate, cervix, or breast cancers in the last 3 years.My bilirubin levels are below 1.5 mg/dL, or below 3.0 mg/dL if I have Gilbert's syndrome.I am allergic to certain drug ingredients used in the study.My tumor has RAS mutation and is stable in DNA repair, confirmed by specific tests.My blood clotting time is normal or slightly above, unless I'm on blood thinners.You have experienced anaphylaxis in the past or have had uncontrolled asthma within the last 5 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SX-682, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT04599140 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical experiment establish a precedent?
"SX-682, a CXCR1/2 inhibitor, was first studied in 2012 by Ono Pharmaceutical Co. Ltd. Subsequent to the initial study involving 659 patients, this drug obtained Phase 1 & 2 approval and currently has 718 active trials spread over 49 countries with 2354 cities being involved in the research process."
Answered by AI
Is there capacity for additional participants in this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this trial, which was initially posted on October 14th 2020, is now enrolling participants. A total of 53 patients will be recruited from one medical site."
Answered by AI
Has SX-682, a CXCR1/2 Inhibitor, been previously tested in any clinical experiments?
"Currently, there are 82 phase 3 trials and 718 total clinical studies examining CXCR1/2 Inhibitor SX-682. Most of these investigations take place in Zürich, Switzerland; however, a grand total of 40237 sites across the globe have been involved with this research."
Answered by AI
What maladies is the CXCR1/2 Inhibitor SX-682 primarily employed to remedy?
"CXCR1/2 Inhibitor SX-682 has been approved for the management of various malignant neoplasms, including unconquerable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."
Answered by AI
How many participants have been recruited for this clinical research?
"Affirmative. Clinicaltrials.gov reveals that this investigation is currently recruiting individuals for participation, with the first posting on October 14th 2020 and most recent edit occurring on August 17th 2022. The trial requires 53 participants from a single location."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
Why did patients apply to this trial?
I have recovered from the surgery and chemotherapy I had for my colon cancer last year. I am interested in better ways to deal with this cancer. My CT scans recently shows the cancer has not returned. I am having a colonoscopy next month.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger