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Bavituximab + Pembrolizumab for Head and Neck Cancer
Study Summary
This trial is testing if bavituximab, when combined with a PD-1 inhibitor, can help people with squamous cell head and neck cancer that has gotten worse despite treatment with a PD-1 inhibitor.
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 2022 Phase 2 trial • 80 Patients • NCT04099641Trial Design
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Who is running the clinical trial?
Media Library
- I have a history of active tuberculosis.I am currently being treated for an infection.I have stable brain metastases, not using steroids for 7 days, and no carcinomatous meningitis.I stopped a cancer treatment due to an immune system side effect.I haven't had any cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.I haven't had cancer treatment in the last 2 weeks and have recovered from past treatments, except for mild neuropathy.I have not received a live vaccine within the last 30 days, except for the flu shot.My head and neck cancer has worsened after treatment with drugs like nivolumab or pembrolizumab.My cancer got worse after platinum therapy or within 6 months of cisplatin and radiation treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I agree to use birth control during and up to 120 days after the study.I have been diagnosed with HIV.I am a man who can father children and will use birth control as required, starting with the first dose of the study therapy until 120 days after the last dose.I am 18 years old or older.I have or had lung inflammation not caused by an infection.I am eligible regardless of my gender or ethnicity.I agree to provide a recent biopsy sample or, if not possible, an older sample with the doctor's approval.I am fully active or restricted in physically strenuous activity but can do light work.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My organ functions are within the required range for treatment.
- Group 1: Pembrolizumab + Bavituximab
- 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
Is there an ongoing recruitment of participants for this experiment?
"This experiment, which was initially advertised on January 13th 2020 and has recently been updated (March 17th 2022), is still recruiting volunteers."
What is the current size of this clinical trial's cohort?
"Correct. Clinicaltrials.gov reveals that this medical trial, which was initially posted on January 13th 2020, is actively searching for participants. The goal is to enlist 29 individuals from a single centre."
Could you provide an overview of other Bavituximab experiments?
"At this time, there are 961 Bavituximab clinical trials in progress; 122 of which are at Phase 3. Houston Texas has a high concentration of these studies but the drug is studied all over with 35727 locations hosting such tests."
Has Bavituximab been sanctioned by the FDA?
"There is some evidence of Bavituximab's safety, warranting it a score of 2 on our scale. However, there are no studies that support the efficacy of this medication yet."
What pathologies is Bavituximab commonly employed to address?
"Bavituximab has been clinically proven to treat malignant tumors, unresectable melanoma, and cases of microsatellite instability high."
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