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

Phase 3

Terminated

• Conditions: Platinum-resistant Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
• Interventions: Biological: Pembrolizumab; Biological: Nemvaleukin; Biological: Nemvaleukin and Pembrolizumab Combination; Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Paclitaxel; Drug: Topotecan; Drug: Gemcitabine

• Registration Number: NCT05092360
• Lead Sponsor: Mural Oncology, Inc

Brief 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.

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

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-25
• Study Start: 2022-01-10
• Primary Completion: 2025-01-08
• Study Completion: 2025-05-08
• Status Verified: 2025-06
• Results First Submitted: 2025-06-30
• Results First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Results First Posted: 2025-08-28
• Last Update Posted: 2025-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 456

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab (enrollment completed)	Pembrolizumab	-
Nemvaleukin (enrollment completed)	Nemvaleukin	-
Nemvaleukin and Pembrolizumab Combination	Nemvaleukin and Pembrolizumab Combination	-
Investigator's Choice	Pegylated Liposomal Doxorubicin (PLD)	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.
Investigator's Choice	Topotecan	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.
Investigator's Choice	Gemcitabine	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.
Investigator's Choice	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From the first dose of study drug up to 24 months	Estimates based on Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) as Assessed by Investigator	From the first dose of study drug up to 20 months	Response is based on RECIST v1.1 criteria.
Disease Control Rate (DCR) as Assessed by Investigator	From the first dose of study drug up to 20 months	Response is based on RECIST v1.1 criteria.
Duration of Response (DOR) as Assessed by Investigator	From the first dose of study drug up to 20 months	Response is based on RECIST v1.1 criteria.
Time to Response (TTR) as Assessed by Investigator	From the first dose of study drug up to 20 months	Response is based on RECIST v1.1 criteria.
Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)	From the first dose of study drug up to 20 months	A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From first dose of study drug up to 90 days after last dose (up to 23 months)
Progression-free Survival (PFS) as Assessed by Investigator	From the first dose of study drug up to 20 months

Trial Locations

Locations (117)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Alaska Women's Cancer Care; 🇺🇸 Anchorage, Alaska, United States

Arizona Oncology; 🇺🇸 Tucson, Arizona, United States

University of California, San Diego (UCSD)- Moores Cancer Center; 🇺🇸 La Jolla, California, United States

University of California, Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States

Ventura County Hematology- Oncology; 🇺🇸 Oxnard, California, United States

University of Florida (UF) Health Cancer Center - Orlando Health; 🇺🇸 Orlando, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

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