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CIMAvax Vaccine + Nivolumab + Pembrolizumab for Non-small Cell Lung Cancer and Squamous Head and Neck Cancer
Study Summary
This trial is testing a combination of two cancer treatments - a vaccine and an immunotherapy drug - to see if they are more effective than either treatment alone in treating patients with non-small cell lung cancer or squamous head and neck cancer.
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?
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- Your platelet count is at least 100 billion per liter.Your troponin-I level is within the normal range and your B-type natriuretic peptide (BNP) level is less than 200 pg/ml.I had radiotherapy or gamma knife for cancer outside the brain over 2 weeks ago and have recovered from side effects.I haven't had major surgery or recovered from one in the last 2 weeks.I agree to provide tissue and blood samples for the study.I have had severe heart failure in the last 6 months.Your blood pressure is too high and not controlled with medication.I have had myocarditis before.I have a history of irregular heartbeats from the lower chambers of my heart.I have been diagnosed with either non-small cell lung cancer or squamous cell head and neck cancer.You are expected to live for at least 6 more months.I have not had anti-PD1 or PD-L1 therapy, except if I'm in cohort D, E, or the expansion cohort.I can perform all self-care but may not be able to do heavy physical work.My liver enzymes are within acceptable limits.I have brain metastasis but haven't been treated with steroids and it's stable 4 weeks after radiation.My tumor has a mutation treatable by FDA-approved drugs, but I haven't received them yet.I have an autoimmune disorder but it's either vitiligo or an endocrine issue treated with hormones.I have used steroids for brain metastases or haven't recovered from their side effects, except for short-term or replacement use.I do not have any serious infections or uncontrolled medical conditions.I haven't had a heart attack or major blood clot in the last 6 months, and I don't have severe heart disease.I haven't had cancer treatment in the last 4 weeks.I have a condition that weakens my immune system, like HIV.My cancer has spread to the lining of my brain and spinal cord.I was diagnosed with cancer less than 2 years ago, but it's not advanced skin, in-situ cancers, low-risk prostate cancer, or early breast cancer not on hormonal therapy.My kidney function, measured by creatinine or GFR, is within the normal range.I am eligible for nivolumab treatment.Your heart is pumping blood effectively within the normal range.Your total bilirubin levels in the blood should be within a certain range, unless you have well-documented Gilbert's syndrome, in which case different limits apply.You have enough infection-fighting white blood cells in your body.Your hemoglobin level is at least 9 grams per deciliter.
- Group 1: Phase II Study A and B (CIMAvax, nivolumab)
- Group 2: Phase II Study C, D & E (CIMAvax, pembrolizumab)
- Group 3: Phase I (CIMAvax, nivolumab)
- Group 4: Phase II Study D (CIMAvax, pembrolizumab)
- 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
Could you provide an overview of prior research exploring Laboratory Biomarker Analysis?
"Laboratory Biomarker Analysis was initially studied at City of Hope in 2010, and since then 1035 trials have been completed. Currently 1637 studies are active with a large portion taking place within Cleveland, Ohio."
Are there multiple sites where this clinical research is managed?
"This research project has 5 sites of enrolment, including University Hospitals Cleveland Medical Center in Cleveland; Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis; as well as St. Francis Hospital in Roslyn, along with an additional 5 locations."
Are there still vacancies in the research program?
"Data hosted on clinicaltrials.gov provides evidence that this medical trial is in the process of recruiting patients. It was first advertised on December 22nd 2016 and has been recently updated as of August 19th 2022."
What conditions is Laboratory Biomarker Analysis typically employed to diagnose?
"Laboratory Biomarker Analysis is a popular treatment option for patients with unresectable melanoma, as well as microsatellite instability high and squamous cell carcinoma. In addition, it can be prescribed to treat transplantation-related conditions."
What is the capacity of this trial in terms of participants?
"This trial necessitates 193 participants who fit the criteria. Potential enrollees will have the choice to join at University Hospitals Cleveland Medical Center in Cleveland and Indiana University Melvin and Bren Simon Comprehensive Cancer Centre in Indianapolis, Indiana."
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