Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (ARTISTRY-7)
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|ClinicalTrials.gov Identifier: NCT05092360|
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : March 30, 2023
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|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||January 10, 2022|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2026|
|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
Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
Other Name: Keytruda
Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
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+)
80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
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
1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
- Progression-free survival (PFS) as assessed by Investigator [ Time Frame: Up to 1 year ]
- Objective response rate as assessed by Investigator [ Time Frame: Up to 1 year ]
- Overall Survival Rate [ Time Frame: Up to 3 years ]
- Disease Control Rate (DCR) as assessed by Investigator [ Time Frame: Up to 1 year ]
- Duration of Response (DOR) as assessed by Investigator [ Time Frame: Up to 1 year ]
- Time to Response (TTR) as assessed by Investigator [ Time Frame: Up to 18-24 weeks ]
- Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG) [ Time Frame: Up to 1 year ]
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 3 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092360
|Contact: Senior Direct, Global Clinical Services||888-235-8008 (US Only)||email@example.com|
|Contact: Senior Direct, Global Clinical Services||1-571-599-2702 (Global)||firstname.lastname@example.org|
|Study Director:||Rita Dalal, MD||Alkermes, Inc.|
|Responsible Party:||Alkermes, Inc.|
|Other Study ID Numbers:||
GOG-3063 ( Other Identifier: The GOG Foundation )
ENGOT-OV68 ( Other Identifier: European Network Gynaecological Oncological Trial groups )
KEYNOTE-C71 ( Other Identifier: Merck )
|First Posted:||October 25, 2021 Key Record Dates|
|Last Update Posted:||March 30, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Epithelian Ovarian Cancer
pegylated liposoma doxorubicin
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action