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Bintrafusp Alfa + Chemotherapy for Ovarian Cancer
Study Summary
This trial will study the safety and effectiveness of a new drug for ovarian cancer when used with chemotherapy.
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 have tested positive for HIV.I have been treated with specific immune therapy within the last 4 weeks.You have a severe allergy to the study drug or its ingredients, a history of severe allergic reactions, or uncontrolled asthma within the last 5 months.Your heart's electrical activity, measured on an ECG, is too long (more than 450 milliseconds for males and 470 milliseconds for females).I had another cancer but was treated successfully and have been cancer-free for 2 years.You have a history of mental health problems or substance abuse.I had radiotherapy less than 2 weeks before starting the study treatment.I have not received a live vaccine in the last 30 days.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have received an organ or tissue transplant from another person.I have had pneumonitis treated with steroids or currently have it.I am a woman over 18 with a confirmed diagnosis of ovarian cancer.I have never received immune therapy treatments.I can provide a sample of my tumor, either from previous or new biopsy.My cancer has spread to my brain or its coverings.I have not received any treatment for ovarian cancer.I have an active case of tuberculosis.My cancer is of a type called high grade serous.I am currently on IV medication for an infection.I have advanced ovarian cancer and will start chemotherapy with carboplatin and paclitaxel.I have been treated for an autoimmune disease in the last 2 years.I have a history of Hepatitis B or an active Hepatitis C infection.I have a history of bleeding disorders or recent severe bleeding.I do not have any uncontrolled illnesses.My organs are functioning well.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I can take care of myself and am up and about more than half of my waking hours.You are expected to live for at least 12 more weeks.Your doctor has confirmed that your disease can be measured using specific guidelines.
- Group 1: Carboplatin/paclitaxel + Bintrafusp alfa (M7824)
- Group 2: Carboplatin/paclitaxel
- 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 vacancies remaining in this research trial?
"Current data hosted on clinicaltrials.gov reveals that this medical trial, which was first posted on September 1st 2022, is no longer looking for participants. Although the study has concluded recruitment efforts, there are still 1870 other trials actively seeking volunteers to join their research projects."
Could you tell me what other empirical studies have been conducted regarding the efficacy of Bintrafusp alfa (M7824)?
"As of now, 1193 clinical trials are underway to research Bintrafusp alfa (M7824). With 334 studies in Phase 3 and 66775 sites running the trial globally, particularly centered around Shanghai."
Has M7824 (Bintrafusp alfa) acquired FDA clearance?
"Our experts at Power have given Bintrafusp alfa (M7824) a safety score of 1 due to the early phase nature of this trial, which has limited evidence in regards to its efficacy and security."
What are the essential aims of this research undertaking?
"The primary goal of this 36 month clinical trial is to assess the Dose Limiting Toxicities (DLT) associated with treatment. Secondary outcomes that will be monitored include Overall Survival, which denotes the median length of time patients remain alive until death from any cause; Overall Survival at 18 months, representing the proportion of people who have survived for up to 18 months since start of treatment; and Progression-free Survival at 18 months, indicating how many participants are without progression after an observation period of one and a half years. Progressive disease is defined as ≥20% increase in sum LD or appearance/progression of new lesions."
What medical applications does Bintrafusp alfa (M7824) have?
"Bintrafusp alfa (M7824) is an accepted therapeutic intervention for those suffering from melanoma, neoplasm metastasis and lymphomas of the non-Hodgkin variety."
What is the anticipated number of participants in this experiment?
"Unfortunately, no further recruitment is being done for this trial which was first announced on September 1st 2022 and last updated in July 12th of the same year. However, if you are searching for other trials, 677 studies involving carcinoma and ovarian epithelial patients as well as 1193 research projects regarding Bintrafusp alfa (M7824) presently require participants."
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