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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05092360

Collaborator

Merck Sharp & Dohme LLC (Industry)

376

Enrollment

Locations

Arms

58.7

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platinum-resistant Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer	Biological: Nemvaleukin and Pembrolizumab Combination Biological: Pembrolizumab Biological: Nemvaleukin Drug: Pegylated Liposomal Doxorubicin (PLD) Drug: Paclitaxel Drug: Topotecan Drug: Gemcitabine	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

376 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nemvaleukin and Pembrolizumab Combination	Biological: Nemvaleukin and Pembrolizumab Combination Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes Other Names: Nemvaleukin alfa ALKS 4230 Keytruda
Experimental: Pembrolizumab	Biological: Pembrolizumab Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes Other Names: Keytruda
Experimental: Nemvaleukin	Biological: Nemvaleukin Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes Other Names: Nemvaleukin alfa ALKS 4230
Active Comparator: Investigator's Choice 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.	Drug: Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+) Other Names: PLD- CAELYX DOXIL LIPODOX Myocet Drug: Paclitaxel 80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min Other Names: Nov-Onxol Taxol Onxol Paclitaxel Novaplus Drug: Topotecan 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 Other Names: Hycamtin Potactasol Drug: Gemcitabine 1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min Other Names: Gemzar Infugem

Outcome Measures

Primary Outcome Measures

Progression-free survival (PFS) as assessed by Investigator [Up to 1 year]

Secondary Outcome Measures

Objective response rate as assessed by Investigator [Up to 1 year]
Overall Survival Rate [Up to 3 years]
Disease Control Rate (DCR) as assessed by Investigator [Up to 1 year]
Duration of Response (DOR) as assessed by Investigator [Up to 1 year]
Time to Response (TTR) as assessed by Investigator [Up to 18-24 weeks]
Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG) [Up to 1 year]
Incidence of treatment-emergent adverse events (TEAEs) [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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 6 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alkermes Investigator Site	Ventura	California	United States	93030
2	Alkermes Investigator Site	Orlando	Florida	United States	32808
3	Alkermes Investigator Site	Sarasota	Florida	United States	34240
4	Alkermes Investigator Site	Albany	New York	United States	12208
5	Alkermes Investigator Site	Greenville	North Carolina	United States	27834
6	Alkermes Investigator Site	Columbus	Ohio	United States	43215
7	Alkermes Investigator Site	Sioux Falls	South Dakota	United States	57105
8	Alkermes Investigator Site	London	Ontario	Canada	N6A 5W9