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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)

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ClinicalTrials.gov Identifier: NCT05092360
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : May 6, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE October 13, 2021
First Posted Date  ICMJE October 25, 2021
Last Update Posted Date May 6, 2023
Actual Study Start Date  ICMJE January 10, 2022
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2021)		 Progression-free survival (PFS) as assessed by Investigator [ Time Frame: Up to 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Platinum-resistant Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJE
  • 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
  • Biological: Pembrolizumab
    Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
    Other Name: Keytruda
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Nemvaleukin and Pembrolizumab Combination
    Intervention: Biological: Nemvaleukin and Pembrolizumab Combination
  • Experimental: Pembrolizumab
    Intervention: Biological: Pembrolizumab
  • Experimental: Nemvaleukin
    Intervention: Biological: Nemvaleukin
  • 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.
    Interventions:
    • Drug: Pegylated Liposomal Doxorubicin (PLD)
    • Drug: Paclitaxel
    • Drug: Topotecan
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2021)		 376
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Italy,   Korea, Republic of,   Singapore,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05092360
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Alkermes, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alkermes, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Director: Rita Dalal, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP