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Vibostolimab + Pembrolizumab for Advanced Cancer
Study Summary
This trial is testing a new drug, vibostolimab, for safety and efficacy as a treatment for metastatic solid tumors. The drug will be tested as monotherapy and in combination with pembrolizumab or pembrolizumab plus pemetrexed and carboplatin. The primary hypotheses are that vibostolimab is safe and tolerable when administered at the recommended Phase 2 dose, and that the fixed dose of pembrolizumab/vibostolimab coformulation is safe and tolerable.
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?
Media Library
- I can carry out all my usual activities without help.I am not pregnant.I stopped an immune therapy due to a severe side effect.I am taking high doses of steroids or other drugs that weaken my immune system.I have a metastatic solid tumor with no beneficial treatment options available.I cannot stop taking aspirin or NSAIDs, except for low-dose aspirin, for 5 to 8 days.I cannot or will not take folic acid or Vitamin B12 supplements.I am Chinese with a confirmed metastatic solid tumor and have had no more than 2 prior treatments.My cancer has spread and this was confirmed by a lab test.I have cancer that has spread to my brain or spinal cord.I am Japanese, living in Japan, with inoperable stomach cancer that has not improved after treatment.I have stage IV non-squamous NSCLC confirmed by tests.I am currently being treated for an infection.I have had pneumonitis treated with steroids.I have had a bone marrow or organ transplant.I am HIV positive or have active Hepatitis B or C.I have been treated with a drug targeting the TIGIT receptor before.I had cancer before, but it was treated successfully and has been gone for over 5 years.I will not need any cancer treatment other than the trial.I have not had a live virus vaccine in the last 30 days.I have provided a sample of my tumor for testing.I have interstitial lung disease.I have taken hormonal cancer therapy, like tamoxifen, within the last 4 weeks.I have fluid buildup in my abdomen or around my lungs.I agree to use birth control during the study.I still experience side effects from cancer treatment received over 4 weeks ago.I haven't had cancer treatment or major surgery in the last 4 weeks.
- Group 1: pembrolizumab/vibostolimab coformulation
- Group 2: vibostolimab +pembrolizumab+pemetrexed+carboplatin
- Group 3: Advanced solid tumor cohort
- Group 4: vibostolimab Dose 2 Japanese cohort
- Group 5: vibostolimab + pembrolizumab
- Group 6: vibostolimab Dose 1 Japanese cohort
- Group 7: Randomized dose 1 comparison cohort
- Group 8: Randomized dose 2 comparison cohort
- Group 9: vibostolimab
- Group 10: vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide
- Group 11: pembrolizumab/vibostolimab coformulation China cohort
- 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
How many healthcare facilities in the U.S. are presently executing this research project?
"This research is being conducted in three locations: Charlotte, North carolina (Investigational Site 0011), Nashville Tennessee (Investigational Site 0004) and New Haven Connecticut (Investigational Site 0003). An additional nine sites are also included."
What is the primary medical condition that vibostolimab has been employed to address?
"Vibostolimab is a medication frequently prescribed to treat disease, but has also shown efficacy in remedying Hodgkin's Disease, Metastatic Cutaneous Squamous cell carcinoma and refractory Testicular cancer."
Have there been any other investigations into vibostolimab's efficacy?
"Vibostolimab was initially studied by the City of Hope Comprehensive Cancer Center in 1997, and since then 2,258 trials have been completed. Currently, there are 2,099 active studies related to this medication with a majority being conducted out of Charlotte North carolina."
How many individuals are participating in this medical research?
"Unfortunately, recruitment for this study has ceased as of April 22nd 2022. If you're looking to join a clinical trial, 2379 cancer-related studies and 2099 vibostolimab trials are currently enrolling new participants."
Has vibostolimab been receiving regulatory approval?
"The safety of vibostolimab is tentatively rated at 1, seeing as it's a Phase 1 trial and thus has limited proof-of-concept data."
Are there currently any openings for volunteers to participate in this clinical experiment?
"According to the records of clinicaltrials.gov, this experiment is not currently in need of volunteers; it was initially listed on December 13th 2016 and most recently updated April 22nd 2022. Although there are no vacancies at present, 4478 other trials are presently looking for subjects."
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