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

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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Study Stats
Protocol No.
22-5120
Category
Ovarian Cancer
Contact
Surya Nagesh
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05092360
For detailed technical eligibility, visit ClinicalTrials.gov.