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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06433219




Registration number
NCT06433219
Ethics application status
Date submitted
22/05/2024
Date registered
29/05/2024

Titles & IDs
Public title
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
Scientific title
An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination de?ciency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)
Secondary ID [1] 0 0
2024-511202-23-00
Secondary ID [2] 0 0
MS201924_0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tuvusertib (M1774)
Treatment: Drugs - Niraparib
Treatment: Drugs - Lartesertib (M4076)

Experimental: Tuvusertib with Niraparib -

Experimental: Tuvusertib with Lartesertib -


Treatment: Drugs: Tuvusertib (M1774)
Tuvusertib will be administered orally

Treatment: Drugs: Niraparib
Niraparib will be administered orally

Treatment: Drugs: Lartesertib (M4076)
Lartesertib will be administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
Timepoint [1] 0 0
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years.
Primary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Timepoint [2] 0 0
Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years.
Secondary outcome [1] 0 0
Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Timepoint [1] 0 0
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years.
Secondary outcome [2] 0 0
Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Timepoint [2] 0 0
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years.

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent.
* Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening.
* Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be >6 months, with documented disease progression prior to study entry).

OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)

* Measurable disease per RECIST v1.1, as assessed by Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
* Other Protocol defined inclusion criteria could apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the last platinum administration in the second-line setting.
* History of additional malignancy within 3 years before the date of enrollment.
* Known brain metastases, unless clinically stable, that is without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of = 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration.
* Active and/or uncontrolled infection.
* History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
* Organ transplantation, including allogenic stem cell transplant.
* Other Protocol defined exclusion criteria could apply.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/01/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - PARENT - Liverpool
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Denmark
State/province [7] 0 0
Aalborg
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen
Country [9] 0 0
Denmark
State/province [9] 0 0
Odense
Country [10] 0 0
France
State/province [10] 0 0
Angers Cedex 2
Country [11] 0 0
France
State/province [11] 0 0
Caen Cedex 05
Country [12] 0 0
France
State/province [12] 0 0
Lille cedex
Country [13] 0 0
France
State/province [13] 0 0
Lyon
Country [14] 0 0
France
State/province [14] 0 0
Paris cedex 12
Country [15] 0 0
France
State/province [15] 0 0
Paris Cedex 14
Country [16] 0 0
France
State/province [16] 0 0
Paris cedex
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Pierre Benite cedex
Country [19] 0 0
France
State/province [19] 0 0
Strasbourg
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Dresden
Country [23] 0 0
Germany
State/province [23] 0 0
Leipzig
Country [24] 0 0
Germany
State/province [24] 0 0
Muenster
Country [25] 0 0
Israel
State/province [25] 0 0
Haifa
Country [26] 0 0
Israel
State/province [26] 0 0
Jerusalem
Country [27] 0 0
Israel
State/province [27] 0 0
Ramat Gan
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Catania
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Napoli
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Rome
Country [34] 0 0
Poland
State/province [34] 0 0
Gdynia
Country [35] 0 0
Poland
State/province [35] 0 0
Krakow
Country [36] 0 0
Poland
State/province [36] 0 0
Lodz
Country [37] 0 0
Poland
State/province [37] 0 0
Otwock
Country [38] 0 0
Poland
State/province [38] 0 0
Torun
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Girona
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Switzerland
State/province [42] 0 0
Bellinzona
Country [43] 0 0
Switzerland
State/province [43] 0 0
Frauenfeld
Country [44] 0 0
Switzerland
State/province [44] 0 0
Liestal
Country [45] 0 0
Switzerland
State/province [45] 0 0
St. Gallen
Country [46] 0 0
Switzerland
State/province [46] 0 0
Zuerich
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Guildford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Leeds
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
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
Medical Responsible
Address 0 0
EMD Serono Research & Development Institute, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US Medical Information
Address 0 0
Country 0 0
Phone 0 0
888-275-7376
Fax 0 0
Email 0 0
eMediUSA@emdserono.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available to whom?
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://bit.ly/IPD21


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/NCT06433219