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Pemetrexed + Pembrolizumab for Salivary Gland Cancer
Study Summary
This trial tests the effect of combining two cancer treatments: chemotherapy drug pemetrexed with immunotherapy drug pembrolizumab. The purpose is to see if this combo is more effective than pemetrexed alone in treating patients with recurrent or metastatic salivary gland 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.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have had pneumonitis treated with steroids or currently have it.I have not received any live vaccines or been part of a drug study in the last 4 weeks.I am willing to give tissue samples for research.I have received an organ or tissue transplant from another person.I am HIV-positive and my condition is well-managed with medication.I am 18 years old or older.I have an active HIV infection with a CD4+ count below 500/ml and am not on anti-retroviral treatment.I do not have any severe ongoing illnesses that would interfere with the study.I have had certain types of cancer but am now considered to have less than a 30% risk of it coming back.I only use steroids for allergies, asthma, or local pain, not more than 10 mg/day of prednisone.My salivary gland cancer has returned or spread and cannot be cured with surgery or radiation.My kidney function, measured by creatinine levels or clearance, is within the required range.My blood clotting tests are normal or within the target range if I'm on blood thinners.My cancer has spread to the lining of my brain and spinal cord.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I may have certain stable conditions or use specific medications, but not as a form of systemic treatment.I have recovered from radiation side effects and don't need steroids or have lung inflammation from radiation.I haven't taken immunosuppressive drugs in the last 14 days.I have not had any other cancer within the last 2 years.I agree to use birth control during and for 6 months after treatment.I haven't had cancer surgery, systemic therapy, or radiation within the last 3 weeks.I have not received a live vaccine in the last 4 weeks.I have recovered from side effects of past treatments or surgeries.I have active cancer spread to my brain or spinal cord.I may have mild neuropathy, fatigue, or hair loss.My brain metastases are stable, not growing, and I haven't used steroids in the last 14 days.I had a severe reaction to previous immunotherapy.I have had severe side effects from immunotherapy, especially affecting my nerves or eyes.I had mild hormone-related side effects but am stable on my current hormone therapy.My cancer has grown in an area previously treated with radiation.I have previously been treated with checkpoint inhibitors for my cancer.I am fully active or can carry out light work.My health status meets the criteria without needing extra help from medications or recent blood transfusions.I have previously been treated with checkpoint inhibitors.I may have had any number of treatments for my cancer that has come back or spread.
- Group 1: Treatment (pembrolizumab, pemetrexed)
- 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 is the FDA's current stance on Pembrolizumab?
"Pembrolizumab was given a score of 2 by our team at Power. This is because, although there is data supporting its safety, there is none yet affirming its efficacy--as is typical for Phase 2 trials."
What prior research has been conducted with Pembrolizumab?
"Pembrolizumab was first studied in 2005 at Hematology-Oncology Associates of Illinois. Since then, a total 533 clinical trials have completed. There are 1174 live clinical trials as of now, with many of them based in Jacksonville, Florida."
Are we enrolling patients for this research project at the moment?
"Yes, this trial is still recruiting patients according to the information available on clinicaltrials.gov. The study was originally posted on 7/23/2021 and was most recently updated on 3/15/2022."
What cancers has Pembrolizumab been most successful in treating?
"Pembrolizumab is the standard of care for treating unresectable melanoma. Pembrolizumab has also shown efficacy in other conditions, such as microsatellite instability high, locally advanced nonsquamous non-small cell lung cancer, and high risk of recurrence."
How many patients are included in this clinical trial?
"The most recent update on clinicaltrials.gov affirms that this study is still recruiting patients. This research project was initially posted on July 23rd, 2021 and was last edited March 15th, 2022. In total, the trial needs 45 individuals from 5 different locations."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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