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Durvalumab +/− Tremelimumab for Advanced Cancer
Study Summary
This trial is testing the safety of durvalumab, with or without tremelimumab, in combination with chemotherapy for patients with advanced solid tumors.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 33 Patients • NCT03007407Trial Design
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- I am eligible and can receive the treatment options listed in the study.My cancer is advanced, cannot be surgically removed, and cannot be cured.I have small cell lung cancer that hasn't been treated yet.I have given permission for my tumor sample to be used for research.I have recovered from side effects of my previous cancer treatments.I am currently receiving treatment for another cancer.I can care for myself and am up and about more than 50% of my waking hours.I am fit for first-line cancer treatment despite my limited ability to perform daily activities.I have not received etoposide-carboplatin but may have had other chemotherapy.My liver and kidney functions are within the required limits.I have had autoimmune or inflammatory disorders in the last 3 years.I am a male willing to use contraception during and after the study as required.I am allergic to durvalumab, tremelimumab, or their ingredients.I have not had severe immune reactions from treatments, organ transplants, or primary immunodeficiency.I have not received a live vaccine in the last 30 days.I have not had chemotherapy for my advanced disease.I agree to use effective birth control.I have received treatments like immunotherapy or targeted therapy before.I cannot undergo standard chemotherapy.I can start the trial treatment within 2 days of signing up.I am using effective birth control and will continue for 6 months after my last treatment dose.I have had one previous chemotherapy treatment.I have small cell lung cancer and have completed two cycles of etoposide-carboplatin before joining.I have small cell lung cancer and haven't had chemotherapy before joining this study.I have had cancer treatment with specific antibodies without severe side effects or needing steroids for them.It's been over 4 weeks since my last radiation treatment.I had surgery over 4 weeks ago and my wound has healed.I have recovered from serious side effects of previous treatments.I will not donate sperm during the trial.My partner uses effective birth control.I am not currently taking any experimental drugs or cancer treatments.My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.I have not had recent serious heart problems or uncontrolled heart conditions.
- Group 1: durvalumab ± 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
In how many areas is this investigation accessible?
"This medical trial is operating out of CHUM - Hopital Notre-Dame in Montreal, Quebec; Tom Baker Cancer Centre in Calgary, Alberta; and Juravinski Cancer Centre at Hamilton Health Sciences based in Hamilton, Ontario. Additionally, there are 7 other research sites participating as well."
Is this pioneering trial the inaugural of its kind?
"At present, there are 340 active trials involving durvalumab administered in 1327 cities and 58 countries. These studies first began back in 2007 when AstraZeneca sponsored a Phase 2 drug approval study featuring 37 participants. Since then, 123 more clinical investigations have been conducted around the world."
What potential risks are associated with durvalumab treatments?
"Due to its Phase 1 status, durvalumab's safety is assessed as a score of 1. This reflects the limited amount of data available on this drug's efficacy and security."
Has durvalumab been previously tested in other clinical investigations?
"As of today, 340 studies are ongoing looking into durvalumab with 52 trials in Phase 3. Most notably, Cordoba Texas is running the majority of these experiments; however, 13098 other locations around the world have clinical trials for this drug."
What is the aggregate enrollment rate for this clinical investigation?
"Unfortunately, this clinical trial is no longer accepting patients. Initially added to the database on October 1st 2015 and last updated September 23rd 2022, it has reached its recruitment capacity. However, those seeking alternative trials can choose from a pool of 2339 cancer-focused studies or 340 durvalumab investigations that are actively recruiting participants."
Are there opportunities for new participants to join this research endeavor?
"Unfortunately, this trial is not accepting participants at the moment. It was first posted on October 1st 2015 and last updated September 23rd 2022. However, if you are looking for other trials in cancer treatment or durvalumab-related research there are currently 2379 and 340 studies respectively actively seeking volunteers."
What are the primary applications of durvalumab treatment?
"Durvalumab is typically utilized to treat unresectable stage III non-small cell lung cancer, with further efficacy for metastatic urothelial carcinoma and advanced directives."
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