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 |
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Recruitment Status :
Recruiting
First Posted : October 25, 2021
Last Update Posted : February 3, 2023
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Sponsor:
Alkermes, Inc.
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Alkermes, Inc.
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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 |
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 |
| 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 : | January 10, 2022 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
Drug Information available for:
Pembrolizumab
| 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:
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| Experimental: Pembrolizumab |
Biological: Pembrolizumab
Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
Other Name: 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:
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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.
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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:
Drug: Paclitaxel 80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
Other Names:
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:
Drug: Gemcitabine 1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
Other Names:
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Primary Outcome Measures :
- Progression-free survival (PFS) as assessed by Investigator [ Time Frame: Up to 1 year ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
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
Contacts
| Contact: Senior Direct, Global Clinical Services | 888-235-8008 (US Only) | clinicaltrials@alkermes.com | |
| Contact: Senior Direct, Global Clinical Services | 1-571-599-2702 (Global) | clinicaltrials@alkermes.com |
Locations
| United States, Alaska | |
| Alkermes Investigator Site | Recruiting |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Alkermes Investigational Site | Recruiting |
| Tucson, Arizona, United States, 85711 | |
| United States, California | |
| Alkermes Investigator Site | Recruiting |
| Oxnard, California, United States, 93030 | |
| United States, Florida | |
| Alkermes Investigator Site | Recruiting |
| Orlando, Florida, United States, 32808 | |
| Alkermes Investigator Site | Recruiting |
| Sarasota, Florida, United States, 34240 | |
| United States, Maryland | |
| Alkermes Investigator Site | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Alkermes Investigator Site | Recruiting |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, New Jersey | |
| Alkermes Investigator Site | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New Mexico | |
| Alkermes Investigator Site | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Alkermes Investigator Site | Recruiting |
| Albany, New York, United States, 12208 | |
| Alkermes Investigator Site | Recruiting |
| Hawthorne, New York, United States, 105832 | |
| Alkermes Investigator Site | Recruiting |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Alkermes Investigator Site | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Alkermes Investigator Site | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Alkermes Investigator Site | Withdrawn |
| Columbus, Ohio, United States, 43215 | |
| United States, Oregon | |
| Alkermes Investigator Site | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Alkermes Investigator Site | Recruiting |
| Portland, Oregon, United States, 97213 | |
| United States, South Carolina | |
| Alkermes Investigator Site | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Alkermes Investigator Site | Recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Texas | |
| Alkermes Investigator Site | Recruiting |
| Austin, Texas, United States, 78731 | |
| Alkermes Investigator Site | Recruiting |
| Bedford, Texas, United States, 76022 | |
| Alkermes Investigator Site | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| United States, Virginia | |
| Alkermes Investigator Site | Recruiting |
| Gainesville, Virginia, United States, 20155 | |
| Australia | |
| Alkermes Investigator Site | Recruiting |
| Adelaide, Australia, 5000 | |
| Alkermes Investigator Site | Recruiting |
| South Brisbane, Australia, 4066 | |
| Canada, Ontario | |
| Alkermes Investigator Site | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Alkermes Investigator Site | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Alkermes Investigator Site | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Alkermes Investigator Site | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Korea, Republic of | |
| Alkermes Investigator Site | Recruiting |
| Daegu, Korea, Republic of, 42601 | |
| Alkermes Investigator Site | Recruiting |
| Seoul, Korea, Republic of, 03080 | |
| Alkermes Investigator Site | Recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Alkermes Investigator Site | Recruiting |
| Seoul, Korea, Republic of, 06351 | |
| Spain | |
| Alkermes Investigator Site | Recruiting |
| Barcelona, Spain, 08036 | |
| Alkermes Investigator Site | Recruiting |
| Madrid, Spain, 28041 | |
| Alkermes Investigator Site | Recruiting |
| Madrid, Spain, 28046 | |
Sponsors and Collaborators
Alkermes, Inc.
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Rita Dalal, MD | Alkermes, Inc. |
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT05092360 |
| Other Study ID Numbers: |
ALKS 4230-007 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: | February 3, 2023 |
| Last Verified: | February 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 |
Keywords provided by Alkermes, Inc.:
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PROC EOC ALKS 4230 IL-2 Ovarian Cancer KEYNOTE-C71 Platinum Resistant Epithelian Ovarian Cancer Nemvaleukin alfa |
Pembrolizumab ARTISTRY-7 ART-7 paclitaxel pegylated liposoma doxorubicin PLD topotecan gemzar gemcitabine |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Fallopian Tube Diseases Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Doxorubicin Liposomal doxorubicin Pembrolizumab Topotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic |