Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

Official 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)

Details

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 (enrollment completed) Arm 3: Nemvaleukin monotherapy (enrollment completed) Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

Keywords

Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, PROC, EOC, ALKS 4230, IL-2, Ovarian Cancer, KEYNOTE-C71, Platinum Resistant, Epithelian Ovarian Cancer, Nemvaleukin alfa, Pembrolizumab, ARTISTRY-7, ART-7, paclitaxel, pegylated liposoma doxorubicin, PLD, topotecan, gemzar, gemcitabine, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Fallopian Tube Neoplasms, Albumin-Bound Paclitaxel, Doxorubicin, Liposomal doxorubicin, Nemvaleukin and Pembrolizumab Combination, Nemvaleukin, Pegylated Liposomal Doxorubicin (PLD), Pembrolizumab (enrollment completed), Nemvaleukin (enrollment completed)

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, San Diego (UCSD)- Moores Cancer Center
    La Jolla California 92093 United States
  • University of California, Los Angeles (UCLA)
    Los Angeles California 90025 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mural Oncology, Inc
ID
NCT05092360
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 456 people participating
Last Updated