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Combination Therapy for Pancreatic Cancer (ARC-8 Trial)
ARC-8 Trial Summary
This trial is testing a new combination of drugs to treat advanced pancreatic cancer. The goal is to see if it is safe and works better than existing treatments.
ARC-8 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARC-8 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ARC-8 Trial Design
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Who is running the clinical trial?
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- I have at least one tumor that can be measured and it's not in an area treated with radiation.I do not have any health conditions that would make taking new medications dangerous.I have not received any treatment for my metastatic disease.I had treatment for pancreatic cancer that ended over 6 months ago.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.You need to have a negative pregnancy test before starting the treatment and at the beginning of each new treatment period.My cancer is a type of pancreatic cancer confirmed by lab tests.I do not have an active autoimmune disease or a history that required strong immune system medications, except for vitiligo or childhood asthma.You need to have negative tests for hepatitis B, hepatitis C, and HIV before joining the study.I had pancreatic cancer treated with chemo and surgery, relapsed after 6 months.My organs and bone marrow are working well.I have an available tissue sample from my tumor, or I can get a new biopsy.I had major surgery with general anesthesia over 4 weeks ago.I haven't had active cancer in the past year, except for certain curable types.I stopped taking high doses of steroids or similar medicines more than 2 weeks ago.I haven't had any live vaccines in the last 4 weeks.I am able to understand and sign the consent form.
- Group 1: Dose Escalation
- Group 2: Dose Expansion(AB680+Zimberelimab+nab-paclitaxel(NP) & gemcitabine (Gem):Cohort A1 (front-line/1L)
- Group 3: Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L)
- Group 4: Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort B (second-line/2L)
- Group 5: Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort C (front-line/1L)
- 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
Are there any open slots for prospective participants in this study?
"Affirmative. According to information posted on clinicaltrials.gov, this medical study was initially published in November 2019 and recently updated in November 2022. The researchers need 211 participants from 24 different sites for the trial to be successful."
What precedent exists for AB680 in terms of prior clinical trials?
"As of this moment, 1114 clinical trials for AB680 are active and actively recruiting participants with 321 occurring in the final stage. While most research is taking place within Shanghai proper, there are 59453 stations across the world examining various aspects of AB680."
Have any federal regulatory bodies granted approval of AB680?
"Given that AB680 is in its initial stage of testing, our team at Power has evaluated the drug's safety as a score of 1 due to limited clinical evidence related to efficacy and safety."
In what geographic locations is this research endeavor being conducted?
"At the current moment, 24 medical sites are running this experiment. Locations span from Plantation to Spokane and Houston with an additional 21 locations in between. It may be prudent to select a location close by oneself if they choose to take part so as to reduce travel-related burdens."
What medical conditions does AB680 typically treat?
"AB680 is a popular therapeutic agent for treating neoplasm metastasis and other ailments, such as locally advanced non-small cell lung cancer, bladder cancer that has spread elsewhere in the body, and urinary tract malignancies."
What is the cumulative amount of participants enrolled in this trial?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial is currently recruiting participants, which began on November 6th 2019 and was last updated on the 7th of November 2022. This study requires 211 individuals to be enrolled at 24 separate medical sites."
What objectives are researchers looking to accomplish with this trial?
"This 12-month clinical trial will assess the Treatment Emergent Adverse Events (TEAEs) of a given medication. Secondary objectives involve monitoring Overall Survival, Zimberelimab peak plasma concentration (Cmax), and Progression Free Survival per RECIST v1.1 guidelines."
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