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No longer recruiting (closed or complete)Last updated: 1 May 2025

ARTISTRY-7: This phase III study is evaluating the effectiveness of combination immunotherapy (nemvaleukin + pembrolizumab), single agent immunotherapy (nemvaleukin or pembrolizumab), and chemotherapy (PLD, paclitaxel, topotecan or gemcitabine) in people with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancerA Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

ARTISTRY-7

Clinical summary

Summary

Eligible participants will be randomly allocated to one of four research arms.

In Arm 1 (Experimental), participants will receive nemvaleukin (6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes) plus pembrolizumab (200mg; Day 1 of 21-day cycles; IV infusion over 30 minutes).

In Arm 2 (Experimental), participants will receive pembrolizumab alone (200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes).

In Arm 3 (Experimental), participants will receive nemvaleukin alone (6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes).

In Arm 4 (Active Comparator), participants will receive the Investigator's choice of chemotherapy, either: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabin. The Investigator will pre-select the Investigator's choice treatment before the randomization of each participant.

PLD will be administered at 40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel will be administered at 80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan will be administered at 4 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 will be administered at 1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Conditions

This trial is treating people with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Alkermes, Inc.

Scientific Title

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

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