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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Fallopian Tube Cancer; Platinum-resistant Ovarian Cancer; Primary Peritoneal Cancer
• Intervention / Treatment: Biological: Nemvaleukin and Pembrolizumab Combination; Biological: Pembrolizumab; Biological: Nemvaleukin; Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Paclitaxel; Drug: Topotecan; Drug: Gemcitabine

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 (enrollment completed) Arm 3: Nemvaleukin monotherapy (enrollment completed) Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

• Study Type: Interventional
• Enrollment (Estimated): 448
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Senior Direct, Global Clinical Services; Phone Number: 781-614-0100 (US Only); Email: clinicaltrials@muraloncology.com

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Active, not recruiting
    • Cancer Research Sa
  • Blacktown, Australia, 2148
    • Active, not recruiting
    • Blacktown Hospital
  • Brisbane, Australia, 4029
    • Active, not recruiting
    • Royal Brisbane and Women'S Hospital
  • East Melbourne, Australia, 3184
    • Active, not recruiting
    • Epworth Healthcare
  • Garran, Australia, 2605
    • Active, not recruiting
    • Canberra Hospital
  • Nowra, Australia, 2540
    • Active, not recruiting
    • Shoalhaven Cancer Care Centre
  • Randwick, Australia, 2031
    • Active, not recruiting
    • Prince of Wales Hospital
  • South Brisbane, Australia, 4066
    • Active, not recruiting
    • Icon Cancer Centre
  • Wollongong, Australia, 2500
    • Active, not recruiting
    • Wollongong Hospital (Illawarra Shoalhaven Local Health District)
• Austria
  • Feldkirch, Austria, 6800
    • Active, not recruiting
    • LKH Feldkirch
  • Graz, Austria, 8036
    • Active, not recruiting
    • Medizinische Universitaet Graz
  • Innsbruck, Austria, 6020
    • Active, not recruiting
    • Medizinische Universitaet Innsbruck
  • Vienna, Austria, 1090
    • Active, not recruiting
    • Medizinische Universitaet Wien
  • Vienna, Austria, 1130
    • Active, not recruiting
    • Wiener Gesundheitsverbund - Klinik Hietzing
• Belgium
  • Brasschaat, Belgium, 2930
    • Active, not recruiting
    • AZ Klina
  • Brussel, Belgium, 1200
    • Active, not recruiting
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium, 1000
    • Active, not recruiting
    • CHU Saint-Pierre
  • Liège, Belgium, 4000
    • Active, not recruiting
    • Clinique CHC MontLégia
  • Oostende, Belgium, 8400
    • Active, not recruiting
    • AZ Damiaan
  • Roeselare, Belgium, 8800
    • Active, not recruiting
    • AZ Delta
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Active, not recruiting
      • Tom Baker Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Active, not recruiting
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 5W9
      • Active, not recruiting
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Active, not recruiting
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Active, not recruiting
      • Princess Margaret Hospital
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Active, not recruiting
      • Centre Hospitalier Universite de Sherbrooke (CHUS)
• Czechia
  • Brno, Czechia, 65653
    • Active, not recruiting
    • Masarykuv onkologicky ustav
  • Prague, Czechia, 12808
    • Active, not recruiting
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 181 00
    • Active, not recruiting
    • Fakultni nemocnice Bulovka
• France
  • Angers, France, 49055
    • Active, not recruiting
    • Institut de Cancerologie de l'Ouest - site Angers
  • Lyon, France, 69008
    • Active, not recruiting
    • Centre LEON BERARD
  • Marseille, France, 13009
    • Active, not recruiting
    • Institut Paoli-Calmettes
  • Paris, France, 75012
    • Active, not recruiting
    • Groupe Hospitalier Diaconesses Croix Saint Simon
  • Saint-Herblain, France, 44805
    • Active, not recruiting
    • Institut de Cancerologie de l'Ouest - site St-Herblain
  • Strasbourg, France, 67200
    • Active, not recruiting
    • Institut de cancerologie Strasbourg Europe (ICANS)
  • Villejuif, France, 94800
    • Active, not recruiting
    • Gustave Roussy
• Germany
  • Berlin, Germany, 13353
    • Active, not recruiting
    • Charite Universitaetsmedizin Berlin
  • Bonn, Germany, 53127
    • Active, not recruiting
    • Universitaetsklinikum Bonn
  • Essen, Germany, 45136
    • Active, not recruiting
    • KEM | Evang. Kliniken Essen-Mitte gGmbH
  • Heidelberg, Germany, 69120
    • Active, not recruiting
    • Universitaetsklinikum Heidelberg
  • Homburg, Germany, 66421
    • Active, not recruiting
    • Universitaetsklinikum des Saarlandes
  • Kiel, Germany, 24105
    • Active, not recruiting
    • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Mannheim, Germany, D-68167
    • Active, not recruiting
    • Universitaetsmedizin Mannheim
  • Wiesbaden, Germany, 65199
    • Active, not recruiting
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden
• Israel
  • Hadera, Israel, 38100
    • Active, not recruiting
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 34362
    • Withdrawn
    • Carmel Medical Center
  • Haifa, Israel, 3109601
    • Withdrawn
    • Rambam Health Care Campus
  • H̱olon, Israel, 5822012
    • Withdrawn
    • Wolfson Medical Center
  • Jerusalem, Israel, 9112001
    • Active, not recruiting
    • Hadassah Medical Center Ein Karem
  • Ramat Gan, Israel, 5265601
    • Withdrawn
    • Sheba Medical Center
  • Reẖovot, Israel, 7610001
    • Active, not recruiting
    • Kaplan Medical Center
• Italy
  • Aviano, Italy, 33081
    • Active, not recruiting
    • Centro Riferimento Oncologico - Aviano
  • Ponderano, Italy, 13875
    • Active, not recruiting
    • Nuovo Ospedale degli Infermi
  • Prato, Italy, 59100
    • Active, not recruiting
    • Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano
  • Rome, Italy, 168
    • Active, not recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
  • Torino, Italy, 10128
    • Active, not recruiting
    • A.O. Ordine Mauriziano di Torino
  • Treviso, Italy, 31100
    • Active, not recruiting
    • Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso
• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Active, not recruiting
    • Keimyung University Dongsan Hospital
  • Goyang-si, Korea, Republic of, 10408
    • Active, not recruiting
    • National Cancer Center
  • Seoul, Korea, Republic of, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Active, not recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 5505
    • Active, not recruiting
    • Asan Medical Center, University of Ulsan
  • Seoul, Korea, Republic of, 6273
    • Active, not recruiting
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 6591
    • Active, not recruiting
    • Seoul St. Mary's Hospital, The Catholic University of Korea
• Singapore
  • Singapore, Singapore, 329563
    • Active, not recruiting
    • Curie Oncology
  • Singapore, Singapore, 119074
    • Active, not recruiting
    • National University Cancer Institute
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic Barcelona
  • Barcelona, Spain, 8908
    • Recruiting
    • Institut Català d'Oncologia - L'Hospitalet
  • Girona, Spain, 17007
    • Recruiting
    • Institut Catala de Oncologia - Girona
  • Las Palmas De Gran Canaria, Spain, 35016
    • Recruiting
    • Hospital Universitario Insular de Gran Canaria
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • Recruiting
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Clinico Universitario Virgen de la Arrixaca
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario de Valencia
  • Vigo, Spain, 36312
    • Recruiting
    • Hospital Álvaro Cunqueiro
• Taiwan
  • Chang Hua, Taiwan, 500
    • Active, not recruiting
    • Changhua Christian Hospital (CCH)
  • Taichung, Taiwan, 40447
    • Active, not recruiting
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Active, not recruiting
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • Active, not recruiting
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 704
    • Active, not recruiting
    • Linkou Chang Gung Memorial Hospital (CGMHLK)
  • Taipei, Taiwan, 11217
    • Active, not recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10002
    • Active, not recruiting
    • National Taiwan University Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Active, not recruiting
    • Cambridge University - Addenbrooke's Hospital
  • London, United Kingdom, SE1 9RT
    • Active, not recruiting
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • Active, not recruiting
    • University College London Hospital
  • Manchester, United Kingdom, M20 4BX
    • Active, not recruiting
    • The Christie NHS Foundation Trust
  • Oxford, United Kingdom, OX3 9DU
    • Active, not recruiting
    • Oxford University Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Recruiting
      • University of Alabama at Birmingham
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
      • Alaska Women's Cancer Care
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Arizona Oncology
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego (UCSD)- Moores Cancer Center
    • Los Angeles, California, United States, 90025
      • Recruiting
      • University of California, Los Angeles (UCLA)
    • Oxnard, California, United States, 93030
      • Recruiting
      • Ventura County Hematology- Oncology
  • Florida
    • Orlando, Florida, United States, 32808
      • Recruiting
      • University of Florida (UF) Health Cancer Center - Orlando Health
    • Sarasota, Florida, United States, 34240
      • Recruiting
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University (IU)
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Withdrawn
      • Norton Cancer Institute
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Mary Bird Perkins Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
  • Michigan
    • Detroit, Michigan, United States, 48224
      • Recruiting
      • Barbara Ann Karmanos Cancer Institute
    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
      • Trinity Health Ann Arbor Hospital
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Astera Cancer Care
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • University of New Mexico
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Womens Cancer Care Associates
    • Hawthorne, New York, United States, 105832
      • Recruiting
      • Westchester Medical Center
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10065
      • Recruiting
      • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Withdrawn
      • Columbia University
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Active, not recruiting
      • Vidant Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati (UC) - Cancer Institute
    • Columbus, Ohio, United States, 43026
      • Recruiting
      • The Ohio State University (OSU)
    • Columbus, Ohio, United States, 43215
      • Withdrawn
      • Columbus Community Clinical Oncology Program
    • Columbus, Ohio, United States, 43219
      • Recruiting
      • Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Williamette Valley Cancer Institute and Research Center
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Portland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19014
      • Recruiting
      • University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Withdrawn
      • Greenville Health System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera Cancer Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Texas Oncology - Austin Central (Balcones Dr.)
    • Bedford, Texas, United States, 76022
      • Recruiting
      • Texas Oncology - DFWW (Bedford)
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Texas Oncology - Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia - Emily Couric Cancer Center
    • Gainesville, Virginia, United States, 20155
      • Recruiting
      • Virginia Cancer Specialists, PC (Lake Manassas Dr)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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: Keytruda; 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: Myocet; DOXIL; PLD- CAELYX; LIPODOX; Drug: Paclitaxel; 80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min; Other Names: Taxol; Nov-Onxol; 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
Experimental: Pembrolizumab (enrollment completed)	Biological: Pembrolizumab; Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes; Other Names: Keytruda
Experimental: Nemvaleukin (enrollment completed)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS) as assessed by Investigator	Up to 1 year
Objective response rate as assessed by Investigator	Up to 1 year
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

Collaborators and Investigators

• Sponsor: Mural Oncology, Inc
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Mural Oncology Medical Monitor, Mural Oncology, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: paclitaxel; Pembrolizumab; Ovarian Cancer; gemcitabine; ALKS 4230; Nemvaleukin alfa; IL-2; topotecan; PROC; EOC; KEYNOTE-C71; Platinum Resistant; Epithelian Ovarian Cancer; ARTISTRY-7; ART-7; pegylated liposoma doxorubicin; PLD; gemzar
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Immune Checkpoint Inhibitors; Topoisomerase I Inhibitors; Paclitaxel; Pembrolizumab; Albumin-Bound Paclitaxel; Doxorubicin; Liposomal doxorubicin; Topotecan; Gemcitabine
• 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No