Your session is about to expire
← Back to Search
Virus Therapy
Combination Immunotherapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Katherine Bever, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Radiographic disease progression
Histologically or cytologically proven adenocarcinoma of the pancreas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will test a combination of four drugs to treat pancreatic cancer in patients who have already tried one round of chemotherapy.
Who is the study for?
Adults over 18 with metastatic pancreatic cancer that's worsened after chemotherapy can join this trial. They must understand and agree to the study, have at least one measurable tumor, be in good physical condition (ECOG 0 or 1), use birth control, and have proper organ function. Exclusions include allergies to penicillin/sulfa, brain metastases, recent treatments or surgeries, uncontrolled illnesses, certain drug uses, severe hypersensitivities, significant heart disease or infections like HIV.Check my eligibility
What is being tested?
The trial is testing a combination of drugs: Tadalafil plus immunotherapies Pembrolizumab and Ipilimumab along with CRS-207 vaccine therapy on those with advanced pancreatic cancer who've had prior chemo. It aims to assess safety and how well these work together against the cancer.See study design
What are the potential side effects?
Possible side effects may include allergic reactions; immune-related issues affecting organs; fatigue; skin problems; hormonal changes; flu-like symptoms from CRS-207; headaches or muscle pain from Tadalafil. Each person might experience different side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened as shown by imaging tests.
Select...
My cancer is a type of pancreatic cancer confirmed by lab tests.
Select...
My cancer has spread and I've received treatment for it.
Select...
I have at least one tumor that can be measured.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (irORR) using immune Response Evaluation Criteria for Solid Tumors (iRECIST)
Secondary outcome measures
Number of participants experiencing grade 3 or above drug-related toxicities
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil
2014
Completed Phase 4
~3280
Pembrolizumab
2017
Completed Phase 2
~2010
Ipilimumab
2014
Completed Phase 3
~2620
CRS-207
2015
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,888 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,903 Total Patients Enrolled
Lustgarten FoundationOTHER
23 Previous Clinical Trials
5,356 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use more than 4 grams of acetaminophen daily.My cancer has worsened as shown by imaging tests.You are currently using extra oxygen at home.I had surgery within the last 4 weeks.I have not had any vaccines in the past 14 days, or a COVID vaccine in the last 7 days, or a live vaccine in the last 30 days.I have poor vein access for IVs.I have been diagnosed with HIV, Hepatitis B, or Hepatitis C.I have a serious fluid buildup in the lining of my lungs.My blood and organ tests meet the study's requirements.I do not have any unmanaged ongoing illnesses.I have received a transplant from a donor.I am not taking any medication that stimulates guanylate cyclase.I have fluid buildup in my abdomen confirmed by tests.You are allergic to both penicillin and sulfa.I have a serious heart condition.I have taken steroids in the past two weeks.You have an implant or device that cannot be easily taken out.You have artificial joints or implanted medical devices that cannot be easily taken out.I expect to need more cancer treatments while in this study.I have had a condition where my eye's optic nerve was damaged due to lack of blood flow.My cancer is a type of pancreatic cancer confirmed by lab tests.I was hospitalized for a severe drop in blood pressure in the last 6 months.I am not taking any strong or moderate drugs that affect liver enzymes.My cancer has spread and I've received treatment for it.I have at least one tumor that can be measured.I am fully active or have some restrictions but can still care for myself.I have not taken immunosuppressive drugs in the last week.I have a wound, ulcer, or bone fracture that hasn't healed.I use organic nitrates for my condition.I am 18 years old or older.You had a serious allergic reaction to any monoclonal antibody.You have had a very bad allergic reaction to tadalafil in the past.I agree to have a tumor biopsy at the start and during the study.I haven't had cancer treatment in the last 2 weeks.I have or had cancer spread to my brain.You drink a lot of alcohol, at least 5 drinks per day.You have a current autoimmune disease or symptoms of one.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207
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.
How many participants have been admitted to this research project?
"Affirmative. Per the information on clinicaltrials.gov, this research project is presently searching for participants and was first posted on August 22nd 2022 and last edited a day later. The study requires 20 subjects to be recruited from 1 medical centre."
Answered by AI
What medical conditions has CRS-207 been used to help alleviate?
"CRS-207 is normally prescribed for patients suffering from unresectable melanoma. Additionally, this medication can help those with microsatellite instability high, pulmonary arterial hypertension and a heightened risk of relapse."
Answered by AI
Could you enlighten me on other investigations involving CRS-207?
"Currently, 1268 studies have been initiated to analyze CRS-207. Out of these experiments, 159 are in their third phase. With a focus on Houston, Texas as the primary site for research into this medication; there is also data being collected at 54853 other locations across the globe."
Answered by AI
Are applications being taken for the current trial?
"Based on the evidence hosted by clinicaltrials.gov, this medical trial is still actively recruiting participants. This study was first announced on August 22nd 2022 and has most recently been updated on August 23rd 2022."
Answered by AI
Has the FDA sanctioned CRS-207 for use?
"The safety of CRS-207 was assessed as a 2 on the 1 to 3 scale due to it being in Phase 2, thus having some evidence for its safety but no data confirming efficacy."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger