A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma (NCT04624178) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma
United States20 participantsStarted 2020-11-05
Plain-language summary
The purpose of this study is to find out whether combining the study drugs rucaparib and nivolumab may be an effective treatment for advanced and/or metastatic LMS, and whether the study treatment works as well as the standard chemotherapy for this type of cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female age ≥ 18 years at the time of informed consent
* Be willing and able to provide written informed consent/assent for the trial
* Be willing to comply with treatment protocol
* Subjects must have a histologically confirmed unresectable/metastatic LMS
* Availability of archival tissue for correlative studies. Either a paraffin block or at least 20 unstained slides are acceptable
* Adequate performance status: ECOG 0 - 2
* Subjects must have had at least 1 but not more than 3 prior lines of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their LMS. Patients who decline the standard of care first-line systemic therapy will be eligible for this trial. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.
* Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
* Adequate organ function determined within 14 days of treatment initiation, defined as per Hematological
* Absolute neutrophil count (ANC) ≥1.5 K/mcL
* Platelets ≥100 K/ mcL
* Hemoglobin ≥9 g/dL Renal
* Serum creatinine OR Measured or calculated creatinine clearance Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2. For calculated CrCL, the Cockcroft Gault formula or institutional standard formula can be used.…