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Durvalumab + Tremelimumab for Ovarian Cancer
Study Summary
This trial is testing how well two immunotherapies, durvalumab and tremelimumab, work in treating ovarian, primary peritoneal, or fallopian tube 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 2019 Phase 2 trial • 33 Patients • NCT03007407Trial Design
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- I have or had inflammatory bowel disease.The informed consent must be written and signed by the subject prior to performing any protocol-related procedures, including screening evaluations.Your heart's electrical activity, measured by ECG, shows a prolonged QT interval.I do not have any uncontrolled illnesses.I have had cancer before, but it fits the exceptions.My blood tests for organ function and bone marrow are within normal ranges.I am willing and able to follow the study's requirements, including treatments, visits, and biopsies.I haven't taken immunosuppressive drugs in the last 28 days, except for allowed exceptions.My cancer is a specific type of ovarian, peritoneal, or fallopian tube cancer, or I have uterine serous carcinoma with certain mutations.I am fully active or restricted in physically strenuous activity but can do light work.I am fully active or can carry out light work.I have had severe side effects from previous immunotherapy.I have an ongoing blockage in my intestines.I am 18 years old or older.I have no lasting side effects from cancer treatment, except for hair loss.I am not able to participate in the study's surveys because I do not speak English.I am willing and able to follow the study's requirements, including treatments, visits, and biopsies.My cancer got worse or came back within 6 months after platinum-based treatment.You have had severe allergic reactions to certain medications in the past.I have had cancer spread to my brain or its coverings.I have had an autoimmune disease in the last 2 years.I have not received a live vaccine within 30 days before joining the study or before getting Durvalumab or Tremelimumab.You have a history of a weakened immune system from birth.I received my last cancer treatment within the required timeframe.I have been diagnosed with tuberculosis in the past.I have seizures that are not controlled by medication.I am 18 years old or older.Your blood and organ function must be at certain levels: Hemoglobin should be at least 9.0 g/dL, ANC should be at least 1.5 x 10^9/L, Platelet count should be at least 100 x 10^9/L, Bilirubin should be below a certain level, and liver and kidney function should also be within specific ranges.You have had an organ transplant from another person.I am not able to become pregnant or I have tested negative for pregnancy before joining the study.You have a disease that can be measured using a specific set of guidelines.
- Group 1: Arm II (combination tremelimumab, durvalumab)
- Group 2: Arm I (sequential tremelimumab, durvalumab)
- 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
Are there any additional precedents of research with Tremelimumab?
"Currently, there are 340 active clinical trials exploring the efficacy of Tremelimumab. Out of these investigations, 52 have reached Phase 3 and are based primarily in Cordoba Texas. Additionally, over 13 thousand locations across our planet are conducting research with this medication."
What medical issues has Tremelimumab been prescribed to address?
"For most cases of stage III non-small cell lung cancer that are not operable, tremelimumab is usually prescribed. Furthermore, this medication has been found to be beneficial for metastatic urothelial carcinoma and other advanced directives."
How many individuals are the maximum capacity for this experimental endeavor?
"Affirmative, clinicaltrials.gov affirms that this experimental study is actively seeking participants. It first made its debut on the 18th of May 2017 and was updated most recently on July 19th 2022, with a need for 175 individuals to be recruited from one site alone."
Are there still opportunities to join this trial as a participant?
"Clinicaltrials.gov evidences that this experiment has been recruiting since May 18th, 2017 and their most recent alteration occured on July 19th, 2022."
Is this trial unique in its approach to treating the condition?
"Records show that there are 340 active trials for tremelimumab, available in 58 different countries and 1327 cities. The first trial involving this drug was conducted by AstraZeneca back in 2007 with 37 participants; 123 studies have been completed since then. This particular study has progressed to the second phase of its approval process."
Has Tremelimumab been given the green light by regulatory bodies?
"Tremelimumab was ranked as a 2 on our safety scale due to the Phase 2 trial data, which provides evidence for its security but not efficacy."
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