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

M

Mural Oncology

Status and phase

Active, not recruiting
Phase 3

Conditions

Primary Peritoneal Cancer
Fallopian Tube Cancer
Platinum-resistant Ovarian Cancer

Treatments

Biological: Pembrolizumab
Drug: Gemcitabine
Drug: Topotecan
Biological: Nemvaleukin
Drug: Paclitaxel
Biological: Nemvaleukin and Pembrolizumab Combination
Drug: Pegylated Liposomal Doxorubicin (PLD)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05092360
GOG-3063 (Other Identifier)
ALKS 4230-007
APGOT-OV8 (Other Identifier)
ENGOT-OV68 (Other Identifier)
KEYNOTE-C71 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

456 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

456 participants in 4 patient groups

Nemvaleukin and Pembrolizumab Combination
Experimental group
Treatment:
Biological: Nemvaleukin and Pembrolizumab Combination
Pembrolizumab (enrollment completed)
Experimental group
Treatment:
Biological: Pembrolizumab
Nemvaleukin (enrollment completed)
Experimental group
Treatment:
Biological: Nemvaleukin
Investigator's Choice
Active Comparator group
Description:
Options 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.
Treatment:
Drug: Pegylated Liposomal Doxorubicin (PLD)
Drug: Paclitaxel
Drug: Topotecan
Drug: Gemcitabine

Trial contacts and locations

118

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Central trial contact

Senior Direct, Global Clinical Services

Data sourced from clinicaltrials.gov

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