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RecruitingLast updated: 14 May 2024

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)

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 patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

III

Trial Acronym

ARTISTRY-7

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

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.

Ask your doctor if this trial could be right for you.

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