Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Res… (NCT05092360) | Clinical Trial Compass
TerminatedPhase 3
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Stopped: Study terminated due to business and strategic decision.
United States456 participantsStarted 2022-01-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 muci…
What they're measuring
1
Overall Survival (OS)
Timeframe: From the first dose of study drug up to 24 months