TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer (NCT03955978) | Clinical Trial Compass
Active — Not RecruitingPhase 1
TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer
United States10 participantsStarted 2019-10-15
Plain-language summary
Patients with inoperable endometrial cancer have limited treatment options. PD-L1 expression is common in endometrial cancers and RT induces tumor and systemic changes that induce the immune system. The purpose of this trial is to evaluate anti-PD-1/PD-L1 axis therapy in conjunction of standard of care RT for patients with inoperable endometrial cancer in order to establish the safety and efficacy of inducing an anti-tumor immune response.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Newly diagnosed biopsy proven The International Federation of Gynecology and Obstetrics (FIGO) clinical stage I or II endometrial carcinoma.
* Histology of FIGO grade 1-3 endometrioid endometrial carcinoma.
* Medically inoperable per treating gynecologic oncologist.
* Candidate for definitive radiation therapy as determined by treating radiation oncologist.
* At least 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Participant must have adequate organ function, defined as follows:
* Absolute neutrophil count ≥ 1,500/µL
* Platelets ≥ 100,000/µL
* Hemoglobin ≥ 9 g/dL; transfusion is allowed to meet this criterion
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 60mL/min using the Cockcroft-Gault equation
* Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
* International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulant…
What they're measuring
1
Safety and tolerability of the regimen as measured by the grade of toxicities experienced as assessed by CTCAE v5.0
Timeframe: Through 30 days after completion of treatment (estimated to be 10 weeks)