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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05092360




Registration number
NCT05092360
Ethics application status
Date submitted
13/10/2021
Date registered
25/10/2021

Titles & IDs
Public title
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Scientific 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)
Secondary ID [1] 0 0
GOG-3063
Secondary ID [2] 0 0
ALKS 4230-007
Universal Trial Number (UTN)
Trial acronym
ARTISTRY-7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platinum-resistant Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Primary Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nemvaleukin and Pembrolizumab Combination
Treatment: Other - Pembrolizumab
Treatment: Other - Nemvaleukin
Treatment: Drugs - Pegylated Liposomal Doxorubicin (PLD)
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Topotecan
Treatment: Drugs - Gemcitabine

Experimental: Nemvaleukin and Pembrolizumab Combination -

Experimental: Pembrolizumab (enrollment completed) -

Experimental: Nemvaleukin (enrollment completed) -

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.


Treatment: Other: 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

Treatment: Other: Pembrolizumab
Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes

Treatment: Other: Nemvaleukin
Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes

Treatment: Drugs: 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+)

Treatment: Drugs: Paclitaxel
80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min

Treatment: Drugs: 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

Treatment: Drugs: Gemcitabine
1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Objective response rate as assessed by Investigator
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [2] 0 0
Disease Control Rate (DCR) as assessed by Investigator
Timepoint [2] 0 0
Up to 1 year
Secondary outcome [3] 0 0
Duration of Response (DOR) as assessed by Investigator
Timepoint [3] 0 0
Up to 1 year
Secondary outcome [4] 0 0
Time to Response (TTR) as assessed by Investigator
Timepoint [4] 0 0
Up to 18-24 weeks
Secondary outcome [5] 0 0
Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG)
Timepoint [5] 0 0
Up to 1 year
Secondary outcome [6] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Progression-free survival (PFS) as assessed by Investigator
Timepoint [7] 0 0
Up to 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
Accrual to date
Final
456
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Epworth HealthCare - East Melbourne
Recruitment hospital [5] 0 0
Canberra Hospital - Garran
Recruitment hospital [6] 0 0
Icon Cancer Centre - South Brisbane
Recruitment hospital [7] 0 0
Wollongong Hospital (Illawarra Shoalhaven Local Health District) - Wollongong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
3184 - East Melbourne
Recruitment postcode(s) [5] 0 0
2605 - Garran
Recruitment postcode(s) [6] 0 0
4066 - South Brisbane
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
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United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
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United States of America
State/province [9] 0 0
Louisiana
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United States of America
State/province [10] 0 0
Maryland
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United States of America
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Michigan
Country [12] 0 0
United States of America
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New Jersey
Country [13] 0 0
United States of America
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New Mexico
Country [14] 0 0
United States of America
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New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
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Ohio
Country [17] 0 0
United States of America
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Oregon
Country [18] 0 0
United States of America
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Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Austria
State/province [22] 0 0
Feldkirch
Country [23] 0 0
Austria
State/province [23] 0 0
Graz
Country [24] 0 0
Austria
State/province [24] 0 0
Innsbruck
Country [25] 0 0
Austria
State/province [25] 0 0
Vienna
Country [26] 0 0
Belgium
State/province [26] 0 0
Brasschaat
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Belgium
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Brussels
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Belgium
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Brussel
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Belgium
State/province [29] 0 0
Liège
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Belgium
State/province [30] 0 0
Oostende
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Belgium
State/province [31] 0 0
Roeselare
Country [32] 0 0
Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Czechia
State/province [35] 0 0
Brno
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Czechia
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Prague
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France
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Angers
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France
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Lyon
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France
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Marseille
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France
State/province [40] 0 0
Paris
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France
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Saint-Herblain
Country [42] 0 0
France
State/province [42] 0 0
Strasbourg
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France
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Villejuif
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Germany
State/province [44] 0 0
Berlin
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Germany
State/province [45] 0 0
Bonn
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Germany
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Essen
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Germany
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Heidelberg
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Germany
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Homburg
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Germany
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Kiel
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Germany
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Mannheim
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Germany
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Wiesbaden
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Italy
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Aviano
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Italy
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Ponderano
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Italy
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Prato
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Italy
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Rome
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Italy
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Torino
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Italy
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Treviso
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Girona
Country [64] 0 0
Spain
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Las Palmas De Gran Canaria
Country [65] 0 0
Spain
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Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Murcia
Country [67] 0 0
Spain
State/province [67] 0 0
Valencia
Country [68] 0 0
Spain
State/province [68] 0 0
Vigo
Country [69] 0 0
Taiwan
State/province [69] 0 0
Chang Hua
Country [70] 0 0
Taiwan
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Taichung
Country [71] 0 0
Taiwan
State/province [71] 0 0
Tainan
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taipei
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Cambridge
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Manchester
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mural Oncology, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mural Oncology Medical Monitor
Address 0 0
Mural Oncology, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Senior Direct, Global Clinical Services
Address 0 0
Country 0 0
Phone 0 0
781-614-0100 (US Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05092360