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

Recruiting
18 years or above
Female
Phase 3
376 participants needed
1 Location

Brief description of study

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.
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

 
  • Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:
  • Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of thewing: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
  • Age: 18 years or above
  • Gender: Female

Inclusion Criteria:
  • Patient is female and ≥18 years of age.
  • Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous,dometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal.
  • Patient has platinum-resistant/refractory disease, defined as disease progressionwithin 180 days following the last administered dose of platinum therapy beyondg (resistant) or lack of response or disease progression whileving the most recent platinum-based therapy (refractory). Patient must havegressed 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 theum sensitive setting, and no more than 5 prior lines of systemic anticancerherapy in the platinum-resistant setting. Patient must have received at least 1 lineherapy containing bevacizumab.
  • Patient has at least one measurable lesion that qualifies as a target lesion based onRECISTv1.1.
  • Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifyinghival 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)disease progression <3 months after completion of first-line platinum-based therapy(resistant).
  • Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcomaubtype.
  • Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumorwith low malignant potential (ie, borderline or low-grade serous tumor).
  • Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis)≥500 mL within 6 weeks of first dose of study drug.
  • Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has hadure, including intralesional, to IL-12 or analogs thereof.
  • Patient has prior exposure to any anti-PD1/PD-L1 therapy.

Updated on 01 Sep 2026. Study ID: CTO-GOG-3063, ALKS 4230-007, 15811

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