Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)

Stopped early · Phase 3

Conditions studied: Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

In brief

This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Key facts

Study ID

NCT05092360

Run by

Mural Oncology, Inc

People needed

456

Starts

2022-01-10

Expected to finish

2025-05-08

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient is female and ≥18 years of age.
• Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
• Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
• Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.
• Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.
• Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.

You may not qualify if…

• Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).
• Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
• Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
• Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.
• Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
• Patient has prior exposure to any anti-PD1/PD-L1 therapy.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Arizona Oncology — Tucson, Arizona, United States
• University of California, San Diego (UCSD)- Moores Cancer Center — La Jolla, California, United States
• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Ventura County Hematology- Oncology — Oxnard, California, United States
• University of Florida (UF) Health Cancer Center - Orlando Health — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University (IU) — Indianapolis, Indiana, United States
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Trinity Health Ann Arbor Hospital — Ypsilanti, Michigan, United States
• Astera Cancer Care — East Brunswick, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Womens Cancer Care Associates — Albany, New York, United States
• Westchester Medical Center — Hawthorne, New York, United States
• NYU Langone Health — New York, New York, United States
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Vidant Medical Center — Greenville, North Carolina, United States
• AZ Delta — Roeselare, Belgium

Full record on ClinicalTrials.gov

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