Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Mural Oncology, Inc
- Study ID
- NCT05092360
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Fallopian Tube Cancer
- Platinum-resistant Ovarian Cancer
- Primary Peritoneal Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nemvaleukin and Pembrolizumab Combination — BIOLOGICALNemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
- Pembrolizumab — BIOLOGICALPembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
- Nemvaleukin — BIOLOGICALNemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
- Pegylated Liposomal Doxorubicin (PLD) — DRUG40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)
- Paclitaxel — DRUG80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
- Topotecan — DRUG4 mg/m2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min
- Gemcitabine — DRUG1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
Study Details
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 Dates
- Start date
- Jan 10, 2022
- Status verified
- Jun 2025
- Primary completion
- Jan 8, 2025
- Completion
- May 8, 2025
Study Design
- Enrollment
- 456 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nemvaleukin and Pembrolizumab Combination
- Experimental: Pembrolizumab (enrollment completed)
- Experimental: Nemvaleukin (enrollment completed)
- Active Comparator: Investigator's ChoiceOptions for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.
Primary Outcome Measure
Overall Survival (OS) [ Time Frame: From the first dose of study drug up to 24 months ]
Locations (37)
Related coverage on Hipa.ai
- Pembrolizumab Combination Trial for Platinum-Resistant Ovarian Cancer TerminatedPembrolizumab · Aug 28, 2025 · ClinicalTrials.gov
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