A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04624178|
Recruitment Status : Active, not recruiting
First Posted : November 10, 2020
Last Update Posted : September 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Leiomyosarcoma||Drug: Rucaparib Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a Phase II open label study evaluating the combination of rucaparib and nivolumab in patients with refractory LMS.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Rucaparib and Nivolumab in Patients With Leiomyosarcoma|
|Actual Study Start Date :||November 5, 2020|
|Estimated Primary Completion Date :||November 5, 2024|
|Estimated Study Completion Date :||November 5, 2024|
Experimental: Rucaparib in combination with Nivolumab
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
Rucaparib at 600 mg, orally, twice daily, continuously for 28 days.
Nivolumab 480mg intravenously on day 1 of every four-week cycle.
- Best objective response rate [ Time Frame: by 24 weeks ]as assessed by RECIST 1.1
- Progression free survival (PFS) [ Time Frame: at 24 weeks ]PFS is defined as the period from start of study treatment until recurrent or progressive of disease (POD) is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death, or date of last study visit involving assessment of disease status.
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): NCT04624178
|United States, New Jersey|
|Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)|
|Basking Ridge, New Jersey, United States, 07920|
|Memorial Sloan Kettering Monmouth (Limited Protocol Activities)|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen (Limited Protocol Activities)|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Commack (Limited protocol activities)|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester (Limited Protocol Activities)|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Nassau (Limited Protocol Activities)|
|Uniondale, New York, United States, 11553|
|Principal Investigator:||Sujana Movva, MD||Memorial Sloan Kettering Cancer Center|