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Trial record 1 of 1 for:    artistry-7
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Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (ARTISTRY-7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05092360
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Alkermes, 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.

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.

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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


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 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:
  • 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




Primary Outcome Measures :
  1. Progression-free survival (PFS) as assessed by Investigator [ Time Frame: Up to 1 year ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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
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United States, California
Alkermes Investigator Site Recruiting
Ventura, 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, New York
Alkermes Investigator Site Recruiting
Albany, New York, United States, 12208
United States, North Carolina
Alkermes Investigator Site Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Alkermes Investigator Site Recruiting
Columbus, Ohio, United States, 43215
United States, South Dakota
Alkermes Investigator Site Recruiting
Sioux Falls, South Dakota, United States, 57105
Canada, Ontario
Alkermes Investigator Site Recruiting
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Alkermes, Inc.
Merck Sharp & Dohme LLC
Investigators
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Study Director: Rita Dalal, MD Alkermes, Inc.
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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: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
ARTISTRY-7
PROC
EOC
ALKS 4230
IL-2
Ovarian Cancer
KEYNOTE-C71
Platinum Resistant
Epithelian Ovarian Cancer
Nemvaleukin alfa
Pembrolizumab
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