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Etigilimab + Nivolumab for Ovarian Cancer
Study Summary
This trial is testing the side effects and possible benefits of two immunotherapy drugs, etigilimab and nivolumab, in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back and is resistant to platinum-based therapy.
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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 3 trial • 541 Patients • NCT02041533Trial Design
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- Your blood test shows that you have enough infection-fighting cells called neutrophils (ANC > 1500/mm^3) within 28 days of starting the study treatment.You received a live vaccine in the past month before starting the trial.You currently have a blockage in your small or large intestine that has not been treated.You are currently receiving any type of medication for cancer treatment, such as chemotherapy, immunotherapy, biologic therapy, or hormone therapy.Your hemoglobin level must be at least 9.0 g/dL within 28 days before starting the treatment.You have an ongoing, uncontrolled illness.You have had a previous cancer diagnosis, other than the cancer being studied in this clinical trial.You have received certain types of previous treatments, including drugs that activate CD137, antibodies against TIGIT, and drugs that block CTLA-4 or PDL1/PD1.You are allergic to any of the study drugs or any of the substances used to make them.You are able to understand and sign a document that explains the study and your participation in it.Your cancer has returned and is specifically located in your ovaries, fallopian tubes, or abdomen lining and has clear cells.You must be able to perform daily activities without assistance or with minimal help.Your platelet count, which helps with blood clotting, is at least 100 x 10^9/L.You are 18 years old or older when you join the study.You have cancer that has spread to your brain or is pressing on your spinal cord.You have received an organ transplant from another person in the past.You have a current or past history of autoimmune or inflammatory disorders.You have a medical, social, or psychological condition that may affect the study's ability to accurately evaluate treatment or understand the results.You are willing to follow the study's rules and attend all the necessary appointments, treatments, and tests for the entire study period.Your cancer has not responded to platinum-based treatment or has returned within 6 months of previous platinum treatment.You have a tumor that can be accurately measured by imaging techniques like CT or MRI. The tumor must be at least 20 mm in its longest dimension or 10 mm if measured by spiral CT. The imaging must have been done within 4 weeks before starting the treatment.
- Group 1: Treatment (etigilimab, nivolumab)
- 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
Has the recruitment process for this trial been completed or is it still ongoing?
"Affirmative. The information on clinicaltrials.gov reveals that this medical trial is currently searching for participants, with the post first published in October 2021 and last updated in November of the same year. This study requires 20 patients from a single location to be recruited."
What is the current enrollment in this research project?
"Affirmative. Reports on clinicaltrials.gov demonstrate that the recruitment period for this medical trial, which was initiated on October 1st 2021, is currently active. To bolster their research they need to enrol 20 individuals from a single site."
What applications are typically associated with Etigilimab?
"Etigilimab is a popular therapeutic option for treating malignant neoplasms, but can also be used to manage unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinom."
What are the projected results of this research initiative?
"During this 90-day trial, the primary goal is to measure objective response rate (ORR). Secondary objectives include assessing molecular changes with standard descriptive statistics; calculating and contrasting pre-treatment and post-treatment T cell populations and proliferation with paired t-tests; summarizing proportions of macrophage phenotypes; using logistic regression/Cox proportional hazards model to examine relationship between clinical responses & molecular/immunological alterations; estimating median immune-related progression free survival (irPFS) w/ Kaplan Meier product limit estimator & Cox Proportional Hazards Regression as an exploratory analysis due to small sample size, finally"
What potential harms might arise from the use of Etigilimab?
"Our assessment of Etigilimab's safety was a 2, reflecting that there is some data backing its security but no evidence demonstrating the drug's effectiveness."
Could you provide an overview of the previous research done with Etigilimab?
"At present, Etigilimab is being trialled in 82 Phase 3 studies with 718 total active trials. The majority of these clinical assessments for Etiglimab are located within Zürich; however, there exist 40285 other sites running experiments related to this medication."
Is this experiment a pioneering effort in its field?
"Etigilimab has been a topic of research since 2012 when the Ono Pharmaceutical Co. Ltd sponsored its first clinical trial involving 659 participants. Subsequently, Etigilimab gained approval in Phase 1 & 2 trials and is now being studied in 718 live studies across 2356 cities and 49 countries globally."
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