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ATP128 + VSV-GP128 + BI 754091 for Colorectal Cancer (KISIMA-01 Trial)
KISIMA-01 Trial Summary
This trial is assessing the safety and tolerability of the ATP128 vaccine when given alone or in combination with BI 754091. The trial will also assess the efficacy of the combination of ATP128 and VSV-GP128 when given in combination with BI 754091 in patients with microsatellite stable colorectal cancer.
KISIMA-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKISIMA-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KISIMA-01 Trial Design
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Who is running the clinical trial?
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- I have a liver lesion that can be biopsied multiple times.I can take care of myself and am up and about more than half of my waking hours.I have at least one tumor that can be measured on a scan.This is a specific group within the study.I am willing to have two liver biopsies.I have or had hepatitis B or C.My side effects from previous treatments are mild, except for possible hair loss, mild nerve pain, or tiredness.I am 18 years old or older.My heart health does not meet the specific criteria listed, including issues with my heart's rhythm or a low ejection fraction.My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.I am not allergic to any of the drugs or their components used in this study.I have a liver lesion that can be biopsied multiple times.I am willing to have two liver biopsies.I haven't had major surgery in the last 3 months.I haven't had chemotherapy or targeted therapy in the last 15 days.I have had standard treatments for stage IV colon cancer.I have not had experimental immunotherapy or drugs targeting PD-1, PD-L1, or CTLA-4.I am not on high-dose steroids or immunosuppressants.I have a cancer lesion that can be safely biopsied twice.My kidney function, measured by creatinine clearance, is good.I need skin medication that affects my immune system.I have an autoimmune disease, but it's not vitiligo or childhood asthma.I am not pregnant or breastfeeding and either cannot become pregnant or will use effective birth control.I have not received any live vaccines in the last 30 days.My liver enzymes are within the required limits.I have at least one tumor that can be measured on a scan.My cancer did not worsen after receiving initial chemotherapy.You are expected to live for at least one year.I have been treated with VSV-based therapy before.This applies to all groups of people in the study.I have undergone more than one treatment for stage IV disease.Participants are expected to live for at least 3 more months.I have had pneumonitis in the last 5 years.I am eligible for surgery to remove liver metastases and possibly the primary tumor with the goal of no visible cancer remaining.I have a blockage in my intestines.I haven't taken any monoclonal antibody treatments recently, except for Avastin, Erbitux, or Vectibix.My kidney function, measured by creatinine clearance, is good.My bilirubin levels are within the normal range, or I have Gilbert's Syndrome with acceptable bilirubin levels.I have no other cancers needing treatment or that have been active in the last 2 years, except for minor skin cancers or other specific non-aggressive types.My bilirubin levels are within the normal range, or I have Gilbert's Syndrome with acceptable bilirubin levels.I had treatment for stage II or III colorectal cancer, but it's been over 6 months since that treatment ended.I completed my first round of treatment for stage IV disease and my condition is stable or improved.I have or had lung inflammation that needed steroids, or my oxygen level is below 92% without aid.My stage IV colon cancer has spread to the liver only.I can take care of myself and perform daily activities.I have not taken Tamoxifen in the last month.You are expected to live for at least 6 more months.I have been vaccinated against metastatic colorectal cancer.I am 18 years old or older.I have been diagnosed with brain swelling.My stage IV colon cancer has not responded to standard treatments.I have stage IV colon cancer and standard treatments haven't worked for me.You are expected to live for at least 3 more months.I have had standard chemotherapy for stage IV colon cancer.My side effects from previous treatments are mild, except for possible hair loss, mild nerve pain, or tiredness.My kidney, liver, and blood tests are normal as of last week.My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.I have undergone initial standard treatment for stage IV disease.My kidney, liver, thyroid, and blood tests are all within normal ranges.I agree to use birth control and not donate sperm for 6 months after my last treatment dose.I haven't had any radiotherapy in the last 2 weeks, or 4 weeks if it was for my brain, and I've recovered from any side effects.I am currently being treated for a long-term or active infection.My cancer has spread to my brain or its coverings.I can take care of myself and am up and about more than half of my waking hours.You are able to understand the study and are willing to provide written permission to participate.
- Group 1: Cohort 1a
- Group 2: Cohort 3
- Group 3: Cohort 4a
- Group 4: Cohort 2b
- Group 5: Cohort 4b
- Group 6: Cohort 2a
- Group 7: Cohort 2c
- Group 8: Cohort 1b
- 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
What are the main goals of this research project?
"The purpose of this study, as stated by the sponsor Boehringer Ingelheim, is to evaluate the anti-tumor effect of the study treatment over a period of 1 year. This will be done by measuring Progression-free survival (PFS). Additionally, the study will also evaluate secondary outcomes including Relapse Free Survival (RFS) and Duration of Response (DoR)."
Are there many locations where this experiment is being conducted within the city limits?
"There are 6 sites where this clinical trial is currently recruiting patients. These locations include New york, Aurora and Houston amongst others. If you are selected for the study, it would be in your best interest to select a location nearest to you to limit travel requirements."
The sample size of this research project is _____ patients.
"The study requires 96 patients that fit the bill in order to commence. Boehringer Ingelheim, the sponsor of this trial, will be administering the medication from various locations; a few notable places are Weill Cornell Medicine (New york, New York) and University of Colorado Anschutz Medical Campus (Aurora, Colorado)."
Do you have any open spots for participants in this clinical trial right now?
"This is accurate. The listing on clinicaltrials.gov displays that the trial opened recruitment on 7/22/2019 and is currently looking for 96 participants at 6 different sites."
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