A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and TSR-042 in Patients With Platinum Resistant Ovarian Cancer (MOONSTONE)
|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: NCT03955471|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Platinum-resistant Ovarian Cancer||Drug: Niraparib Drug: TSR-042||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and TSR-042 in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE)|
|Actual Study Start Date :||October 3, 2019|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||July 30, 2023|
Experimental: ARM 1
Patients will receive both Niraparib and TSR-042 to evaluate the efficacy and safety of the combination of both drugs.
Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
Other Name: ZEJULA
TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
Other Name: Dostarlimab
- Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]Proportion of patients who have achieved confirmed CR or PR, evaluated using RECIST v1.1 based on Investigator assessment.
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST v.1.1 based on Investigator assessment or death by any cause in the absence of progression by RECIST v.1.1.
- Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST v.1.1 based on Investigator assessment or death by any cause in the absence of progression by RECIST v.1.1.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause.
- Disease Control Rate (DCR) [ Time Frame: Up to 5 years ]DCR is defined as the percentage of patients who have achieved best overall response (BOR) of CR, PR, or SD per RECIST v.1.1 based on the Investigator's assessment.
- Objective Response Rate Based on Independent Review Committee Assessment [ Time Frame: Up to 5 years ]ORR based on independent review committee assessment is defined as the percentage of patients who have achieved confirmed CR or PR per RECIST v1.1 based on the independent review committee assessment.
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): NCT03955471
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center||+44 (0) 20 89904466||GSKClinicalSupportHD@gsk.com|
|United States, Louisiana|
|Mary Bird Perkins||Recruiting|
|Covington, Louisiana, United States, 70433|
|United States, Tennessee|
|Chattanooga Program in Women's Oncology||Recruiting|
|Chattanooga, Tennessee, United States, 37403|