The University of Virginia is participating in a clinical research study for adults ages 18 and over, who have advanced or metastatic Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer that has become resistant to platinum-based therapy. Eligible participants enrolled in this study will be randomly assigned to 1 of 4 available treatments.
• Arm 1: Nemvaleukin in combination with pembrolizumab
• Arm 2: Pembrolizumab monotherapy
• Arm 3: Nemvaleukin monotherapy
• Arm 4: Investigator’s choice chemotherapy
This study is testing an investigational treatment called nemvaleukin alfa (nemvaleukin) in combination with another treatment called pembrolizumab (KEYTRUDA®) in comparison to chemotherapy. Pembrolizumab is an approved treatment for some types of cancer but is not approved for the treatment of ovarian cancer alone or in combination with nemvaleukin. Nemvaleukin is investigational and not approved by any regulatory authority. It is not known if nemvaleukin, alone or in combination, is safe or effective.
This study is being funded by the pharmaceutical company Alkermes, Inc.
The purpose of this study is to find answers to the following research questions:
• How effective is nemvaleukin alone and in combination with pembrolizumab in treating epithelial ovarian, fallopian tube, or primary peritoneal cancer compared with chemotherapy?
• What effect does nemvaleukin alone and in combination with pembrolizumab have on patients’ bodies and epithelial ovarian, fallopian tube, or primary peritoneal cancer?
• What effect does nemvaleukin in combination with pembrolizumab have on overall health and well-being?
• How does nemvaleukin in combination with pembrolizumab move through the body?
• Is nemvaleukin in combination with pembrolizumab safe and well tolerated in subjects with epithelial ovarian, fallopian tube, or primary peritoneal cancer as compared to chemotherapy?
Each arm has different treatment lengths, so an eligible patient’s treatment length will differ depending on what arm to which they are assigned. For Arms 1 and 2, eligible patients will receive up to 35 treatments, which is approximately 2 years. For Arms 3 and 4, eligible patients will be in the study as long as there is evidence that the treatment is helpful for their cancer, and they are tolerating treatment well. The total length of treatment is unknown as eligible patients will continue to receive treatment in this study until their disease worsens, or they experience toxicity (side effects that are severe), they withdraw their consent from the study, or it is decided by the study doctor or sponsor to stop their participation. All drugs will be given via intravenous infusion.
Study-related procedures that are being done beyond the standard of care will be provided at no cost to the eligible patients or their insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05092360
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