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SX-682 + Nivolumab for Pancreatic Cancer
Phase 1
Recruiting
Led By Richard Dunne, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until date of death from any cause up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug combo to see what the max dose is that patients can tolerate while still benefiting from the treatment.
Who is the study for?
This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma who've completed at least 16 weeks of first-line chemo without the cancer getting worse. They must be able to perform daily activities (ECOG status 0 or 1) and not have brain metastases, active pneumonitis, recent major surgery, other cancers in the last three years, or use immunosuppressants. Participants need functioning organs and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests SX-682 combined with Nivolumab as a maintenance therapy to find the highest dose patients can tolerate. It's for those whose disease didn't progress after initial chemotherapy. The goal is to see how well they handle this combination treatment and what effects it has on their cancer.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, potential liver function changes, fatigue, skin issues, digestive disturbances, hormonal imbalances due to immune system interference by Nivolumab and SX-682.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I completed 16 weeks of initial chemotherapy without my cancer getting worse.
Select...
My cancer is a type of pancreatic cancer that has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of enrollment until date of death from any cause up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until date of death from any cause up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerable dose [Safety and Tolerability]
Secondary outcome measures
Overall Survival
Progression Free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: SX-682 and NivolumabExperimental Treatment2 Interventions
SX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill
Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion
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Who is running the clinical trial?
Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
787 Total Patients Enrolled
University of RochesterLead Sponsor
838 Previous Clinical Trials
518,547 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,012 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart disease that limits my daily activities.You have had a serious allergic reaction to a specific type of medication called a monoclonal antibody in the past.Your EKG shows that your heart's QTc interval is longer than 470 milliseconds.You have had a severe allergic reaction (anaphylaxis) or have uncontrolled asthma.I have a history of blood disorders like MDS or MPN.I had major surgery less than 4 weeks ago.I (or my proxy) have signed the consent forms for the study and biomarker tests.I am on steroids or other drugs that affect my immune system.I am fully active or can carry out light work.You have an ongoing autoimmune disease.Women must have a negative pregnancy test within 24 hours before starting the study drug.I have not had any cancer, except for treatable local cancers, in the last 3 years.I am willing and able to follow the study's schedule and requirements.I have cancer that has spread to my brain or its coverings.I am a woman under 62 and have a confirmed FSH level over 40, indicating I am postmenopausal.I have a serious heart or brain blood vessel condition.I am not using herbal treatments for my condition.I am a man and will use highly effective birth control during and for 7 months after the study.I haven't had immunotherapy or experimental drugs in the last 4 weeks.I haven't taken any experimental drugs or high-dose immune-suppressing medications in the last 28 days.I completed 16 weeks of initial chemotherapy without my cancer getting worse.I am 18 years old or older.Before starting the study drug, your recent blood tests should show certain levels for white blood cells, neutrophils, platelets, hemoglobin, creatinine, liver enzymes, and blood clotting factors.I have a history of long QT syndrome.My cancer is a type of pancreatic cancer that has spread.You must have a measurable disease with at least one lesion that can be measured.I have lung disease or had lung inflammation treated with steroids.I have lung inflammation that is not caused by an infection.I have had Hepatitis B or C.I am using highly effective birth control during and for 5 months after the study.I have active tuberculosis.Before the trial, your oxygen level must be at least 90% when measured with a pulse oximeter while breathing regular air.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: SX-682 and 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any precedents for utilizing SX-682 in clinical trials?
"Currently, 717 clinical trials are being conducted to evaluate the efficacy of SX-682. Of those studies, 82 have progressed to Phase 3 testing and they originate from Basel, BE. Additionally, there are 40290 sites around the world running tests with this medication."
Answered by AI
What is the common purpose of administering SX-682?
"SX-682 is known to be effective in the treatment of malignant neoplasms, and has had some success with conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Has SX-682 earned official approval from the Food and Drug Administration?
"Due to the limited dataset available, our analysis concluded that SX-682 can be classified as a 1 on the safety scale. This is due to it being in Phase 1 of its clinical trials, meaning there has been minimal testing regarding both efficacy and safety."
Answered by AI
Are there still recruitment opportunities for this experiment?
"The data available on clinicaltrials.gov affirms that the experiment is currently looking for participants, with the initial listing posted November 23rd 2020 and the most recent edit made to it being on November 18th 2022."
Answered by AI
Is this the inaugural attempt at exploring this research topic?
"Since 2012, SX-682 has been a focus of medical research. The first study was conducted by Ono Pharmaceutical Co. Ltd with 659 participants and led to the drug's approval in both Phase 1 & 2 trials. Currently, 49 countries are running 717 clinical studies on this medication across 2356 cities worldwide."
Answered by AI
How extensive is the cohort of patients participating in this research?
"Affirmative. Per the details on clinicaltrials.gov, this medical trial is actively searching for its recruits; it was established on November 23rd 2020 and last modified on November 18th 2022. The goal of the project is to enrol 20 patients at one site."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Rochester
What portion of applicants met pre-screening criteria?
Met criteria
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