What is ARTISTRY-7?
ARTISTRY-7 is a research study enrolling adult patients with advanced or metastatic (cancer that has spread) epithelial ovarian, fallopian tube, or primary peritoneal cancer that has become resistant to platinum-based therapy.
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 Mural Oncology.
Purpose
What is the purpose of this research?
The purpose of ARTISTRY-7 is to assess the safety and efficacy of investigational nemvaleukin in combination with another treatment called pembrolizumab (KEYTRUDA®) in comparison to chemotherapy as a treatment for advanced or metastatic (cancer that has spread) epithelial ovarian, fallopian tube or primary peritoneal cancer that has become resistant to platinum-based therapy.
Eligibility
A study investigator and staff will determine eligibility on an individual basis.
To be eligible, a participant must meet the following criteria:
- Is a woman, 18 years of age or older
- Is not pregnant or breastfeeding
- Has a diagnosis of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Has received platinum-based therapy and, according to treating physician, stopped responding to it
- Has received bevacizumab (AVASTIN®) in the past
- Doesn’t have an active infection or HIV
- Has not received similar medications (like an IL-2 therapy) in the past
- Additional criteria may apply
Treatments
Information About Treatments
This research study is composed of four treatment groups. During the screening period before enrollment, eligible participants will be randomly assigned to one of the four treatment groups, described here.
The medicines used in this study will be administered by an intravenous (IV, meaning through a person's veins) infusion.
Nemvaleukin in combination with pembrolizumab
Participants will receive 6 µg/kg nemvaleukin per day for 5 consecutive days every 21 days by a 30-minute IV infusion and 200 mg pembrolizumab once every 21 days by a 30-minute IV infusion.
Investigator’s choice chemotherapy
Participants will receive 1 of 4 types of chemotherapy chosen by the study doctor. Dose and schedule will vary but will generally follow 21 to 28 day cycles. Chemotherapy choices include doxil, paclitaxel, topotecan, or gemcitabine.
Nemvaleukin monotherapy
Participants will receive 6 µg/kg nemvaleukin per day for 5 consecutive days every 21 days by a 30-minute IV infusion.
Pembrolizumab monotherapy
Participants will receive 200 mg pembrolizumab once every 21 days by a 30‑minute IV infusion.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
AVASTIN® is a registered trademark of Genentech, Inc.