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

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

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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