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Immune Therapy for Germ Cell Cancer
Study Summary
This trial will test a new immunotherapy treatment for patients with cancer that has returned or worsened after previous treatment.
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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- I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.I am 18 years old or older.I weigh more than 30 kilograms.My cancer has worsened after at least one treatment.My organs and bone marrow are functioning well.I am not pregnant or breastfeeding.I have not had major surgery in the last 28 days.I have been diagnosed with tuberculosis in the past.I have not received a live vaccine within the last 30 days.I haven't taken immunosuppressive drugs in the last 28 days.I have or had an autoimmune or inflammatory disorder.I received my last cancer treatment less than 14 days ago.I have had lung conditions like fibrosis or pneumonia, or my CT scan shows lung inflammation.I have not had any other cancers in the last 5 years.My cancer is a confirmed germ cell tumor.I can take care of myself and am up and about more than half of the day.I am willing and able to follow the study's treatment plan and attend all visits.I have completed treatment for brain metastases, don't need steroids, and have no symptoms.I am post-menopausal or not pregnant if pre-menopausal.I have not had radiation in the last 14 days.I agree not to donate blood during and for 3 months after the study.I have had cancer spread to the lining of my brain and spinal cord.I do not have any uncontrolled illnesses.I have never been treated with PD-1, PD-L1 inhibitors, or anti-CTLA-4 drugs.
- Group 1: Duravalumab + Tremelimumab
- 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
For what purpose is Tremelimumab typically prescribed?
"Tremelimumab is most commonly used as an intervention for unresectable stage iii non-small cell lung cancer. It can also be taken to treat a variety of other conditions including previously untreated, metastatic ureter urothelial carcinoma, and advance directives."
How many people will be taking part in this experiment at most?
"Unfortunately, this specific clinical trial is no longer recruiting patients. The posting date was May 15th, 2017 and the last update was on May 2nd, 2022. However, there are 2499 other trials for seminoma and 345 trials for Tremelimumab that are still looking for participants."
What other scientific investigations have been executed that also included Tremelimumab?
"Tremelimumab was first studied in 2007. As of now, there have been a total of 123 completed studies and 345 live studies. A large number of the current trials are taking place in Harrison, New jersey."
Are there any current open slots for patients who wish to enroll in this clinical trial?
"Unfortunately, this particular clinical study is no longer looking for candidates. Although it was last edited on May 2nd, 2022, the trial was initially posted on 5/15/2017. However, there are many other medical trials (2844 in total) that are still recruiting patients."
Are there negative health effects associated with Tremelimumab?
"Tremelimumab's safety is based on data from Phase 2 trials, which means that while there is some evidence backing its safety, there is no clinical data to support efficacy."
How many sites are running this clinical trial?
"At the moment, this trial is being conducted at 7 clinics. These locations are in Harrison, Commack and Basking Ridge as well some other cities. If you want to enroll, it might be simplest to choose the medical centre closest to your home in order to reduce travel time commitments."
Is this a new or existing study?
"Tremelimumab has a long history, with the first clinical trial taking place in 2007. After the initial Phase 1 drug approval in 2007, there are now 345 active trials being conducted in 1325 cities and 58 countries."
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