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Immunotherapy for Pancreatic Cancer
Phase 1 & 2
Recruiting
Led By David Linehan
Research Sponsored by Vaccinex Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Creatinine should be below the upper limit of normal OR Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Patients must have radiographically measurable disease defined as non-radiated lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 10mm with calipers by radiographic exam. Further details listed in section 5.5.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trialtests the safety & effectiveness of two cancer drugs in people with pancreatic cancer that has worsened after treatment.
Who is the study for?
Adults with metastatic pancreatic adenocarcinoma that worsened after first-line chemo can join. They need measurable disease, have had specific prior treatments, and a life expectancy of at least 3 months. Good organ function and performance status are required. Participants must agree to use contraception and consent to biopsies.Check my eligibility
What is being tested?
The trial is testing the safety of Pepinemab combined with Avelumab in patients whose cancer progressed post-chemo. Phase 2 will check how effective this combo is against metastatic pancreatic adenocarcinoma.See study design
What are the potential side effects?
Possible side effects include immune-related reactions (like inflammation), infusion responses, fatigue, nausea, blood cell changes, increased infection risk, and potential harm to liver or kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal or nearly normal.
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My cancer can be measured on scans and is at least 10mm in size.
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My cancer is a type of pancreatic cancer that has spread.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I've had 5FU or Gemcitabine for cancer, but it didn't work or caused side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 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 Treatment-Emergent Adverse Events [Safety and Tolerability]
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Gastrointestinal disorders
6%
Investigations
6%
Infections and infestations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Single arm, all patients serially enrolled to combination doses of Avelumab and Pepinemab
Find a Location
Who is running the clinical trial?
Vaccinex Inc.Lead Sponsor
11 Previous Clinical Trials
705 Total Patients Enrolled
University of RochesterOTHER
840 Previous Clinical Trials
534,202 Total Patients Enrolled
David LinehanPrincipal InvestigatorDavid_Linehan@URMC.Rochester.edu
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a biliary stent for obstruction.I can follow the study's schedule and requirements.I still have side effects from previous cancer treatments.I have had an organ or bone marrow transplant.I have received an organ or tissue transplant from another person.My bone marrow and organs are functioning normally.My cancer is a specific type of pancreatic cancer.I have an autoimmune disease or need steroids/immunosuppressants, except for vitiligo or childhood asthma.I have had cancer other than skin or early cervical cancer in the last 3 years.I do not have any severe ongoing illnesses that could worsen with the study.I haven't had major surgery or used experimental drugs in the last 28 days.I have received radiation therapy for my advanced local disease.I have lung disease or had lung inflammation treated with steroids.My kidney function is normal or nearly normal.You are currently struggling with alcohol or drug abuse.I agree to use two forms of birth control if my partner can have children.I am allergic to medications similar to Pepinemab or Avelumab.My cancer can be measured on scans and is at least 10mm in size.I have an active Hepatitis B or C infection.I am currently or have been part of a trial for new cancer treatments.My cancer is a type of pancreatic cancer that has spread.I am of childbearing age and have a negative pregnancy test.My cancer came back more than 6 months after finishing my initial treatment.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I've had 5FU or Gemcitabine for cancer, but it didn't work or caused side effects.I have not received a live vaccine within 30 days before starting the study medication, except for non-live flu vaccines.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
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 of using Experimental in clinical research?
"At present, 117 clinical trials for Experimental are underway, with 10 in the advanced Phase 3. Most of these experiments take place in Houston, Texas; however 3765 sites across the nation are participating as well."
Answered by AI
What is the upper limit of individuals involved in this research study?
"Affirmative. According to clinicaltrials.gov, this medical experiment is accepting participants and was first posted on December 10th 2022 before its last update on the 13th of that same month. 48 candidates are needed for a single centre trial site."
Answered by AI
Are there any vacancies for potential participants in this investigation?
"Indeed, the information located on clinicaltrials.gov affirms that this research endeavour is currently enrolling candidates. It was initially posted on December 10th 2022 and edited for the last time on December 13th 2022; 48 participants are needed to be recruited from a single site."
Answered by AI
Does this experiment represent a pioneering breakthrough in medical research?
"Currently, 117 trials that involve Experimental treatments are running in 1043 towns and cities spread across 52 different countries. It all began back in 2014 when EMD Serono Research & Development Institute, Inc. sponsored a Phase 2 study with 204 participants - since then 51 additional studies have been completed."
Answered by AI
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