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Nivolumab + BMS-813160 +/- GVAX for Pancreatic Cancer
Study Summary
This trial will test a combination of three drugs to treat patients with locally advanced pancreatic cancer. The goal is to see if the combination is safe and if it enhances the infiltration of CD8+CD137+ cells in pancreatic ductal adenocarcinomas (PDACs).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't taken strong/moderate CYP3A4 inhibitors or inducers in the last 28 days.I have had stomach or intestine surgery that may affect how I absorb medication.I cannot have blood drawn for medical reasons.I do not have any severe illnesses or conditions that are not under control.I need treatment for fluid buildup in my abdomen.I am fully active or can carry out light work.I am infected with HIV or hepatitis B or C.I am not pregnant or breastfeeding.I have had or currently have lung inflammation not caused by an infection.I have an autoimmune disease, but thyroid conditions are okay.I had surgery less than 28 days before starting the study medication.I have had a stomach or intestine problem in the last 3 months that could affect how I absorb medication.I haven't taken Class I antiarrhythmics in the last 28 days.I have not taken any growth factors like G-CSF in the last 14 days.I am willing to have a biopsy of my pancreatic cancer if surgery is not an option.My cancer has spread to my stomach or the beginning of my small intestine.My pancreatic cancer cannot be removed with surgery.You are currently involved in or have been involved in a study or using a new treatment for cancer that is still being tested.I cannot take medicine by mouth.I am unable or unwilling to follow the study's schedule.I haven't taken cancer drugs or vaccines in the last 28 days.I do not have any cancer except for certain skin, bladder, prostate, or cervical cancers.I have previously received immunotherapy for my condition.I have not received any treatment for my advanced pancreatic cancer.I can swallow pills or capsules.My organs are functioning well according to specific lab tests.I am eligible for FOLFIRINOX-based chemotherapy.I have had a transplant of an organ, tissue, or bone marrow from another person.I haven't taken immunosuppressive drugs in the last 14 days.I am 18 years old or older.I am willing to receive radiation therapy exclusively at Johns Hopkins Hospital.I need to use oxygen at home.I have not received any vaccines in the last 14 days.I am currently being treated for an infection.You are expected to live for at least 3 more months.I have received chemotherapy for pancreatic cancer that was not FOLFIRINOX.I am willing to have a biopsy of my pancreatic cancer.
- Group 1: Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist
- Group 2: Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist
- Group 3: Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there any availability for participants in this clinical investigation?
"Affirmative. The details on clinicaltrials.gov verify that this research is currently accepting participants, which it has been doing since December 12th 2019. As of January 28th 2022, 30 people across one location are needed for the trial to commence properly."
Have any prior experiments assessed the efficacy of CCR2/CCR5 dual antagonist?
"Presently, research into CCR2/CCR5 dual antagonists is a hot-button issue with 718 live studies in total. A significant 82 of these trials are currently taking place during Phase 3 and 40285 locations have been identified as conducting experiments on this subject matter. Notably, the majority of tests for CCR2/CCR5 dual antagonist take place in Zürich BE."
Is this medical research a pioneering effort?
"CCR2/CCR5 dual antagonist has been under the microscope since 2012, when Ono Pharmaceutical Co. Ltd. conducted its first trial with 659 participants. Subsequent Phase 1 & 2 drug approvals led to a surge of interest and now 718 active studies are being carried out in 2356 cities across 49 nations."
How is CCR2/CCR5 dual antagonist utilized to treat various conditions?
"CCR2/CCR5 dual antagonist is typically used to treat malignant neoplasms, but it can also be a beneficial treatment for certain cases of unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."
How many participants are involved in the current clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical research project is still actively recruiting participants and has been since December 12th 2019. The current number of required patients stands at 30 and they can be recruited from a single location."
What are the fundamental goals of this medical experiment?
"This trial will measure the number of participants affected by medication-related side effects over a span of 36 months. Secondary measures include metastasis free survival (MFS), local progression free survival (LPFS) time, and surgical resectability rate. MFS is calculated as the amount of time between cycle 1 day 1 until first documented distant metastases on imaging or death from any cause, LPFS Time is determined based on when immunotherapy began to when there was first evidenced local progression/relapse with complete response through RECIST 1.1 criteria and irRECIST criteria or death, and Surgical Resectability Rate appraises how"
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