TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer
- Conditions
- Endometrial CancerCancer of the Endometrium
- Registration Number
- NCT03955978
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Newly diagnosed biopsy proven The International Federation of Gynecology and<br> Obstetrics (FIGO) clinical stage I or II endometrial carcinoma.<br><br> - Histology of FIGO grade 1-3 endometrioid endometrial carcinoma.<br><br> - Medically inoperable per treating gynecologic oncologist.<br><br> - Candidate for definitive radiation therapy as determined by treating radiation<br> oncologist.<br><br> - At least 18 years of age.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status = 2<br><br> - Participant must have adequate organ function, defined as follows:<br><br> - Absolute neutrophil count = 1,500/µL<br><br> - Platelets = 100,000/µL<br><br> - Hemoglobin = 9 g/dL; transfusion is allowed to meet this criterion<br><br> - Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated creatinine<br> clearance 60mL/min using the Cockcroft-Gault equation<br><br> - Total bilirubin = 1.5 x ULN (=2.0 in patients with known Gilberts syndrome) OR<br> direct bilirubin = 1 x ULN<br><br> - Aspartate aminotransferase and alanine aminotransferase = 2.5 x ULN unless<br> liver metastases are present, in which case they must be = 5 x ULN<br><br> - International normalized ratio (INR) or prothrombin time (PT) =1.5× ULN unless<br> patient is receiving anticoagulant therapy as long as PT or partial<br> thromboplastin (PTT) is within therapeutic range of intended use of<br> anticoagulants. Activated partial thromboplastin time (aPTT) =1.5× ULN unless<br> patient is receiving anticoagulant therapy as long as PT or PTT is within<br> therapeutic range of intended use of anticoagulants<br><br> - Participant receiving corticosteroids may continue as long as their dose is stable<br> for at least 4 weeks prior to initiating protocol therapy.<br><br> - Participant must agree to not donate blood during the study or for 90 days after the<br> last dose of study treatment.<br><br> - Female participant has a negative serum pregnancy test the day of and prior to<br> taking study treatment if of childbearing potential and agrees to abstain from<br> activities that could result in pregnancy from screening through 180 days after the<br> last dose of study treatment, or is of non-childbearing potential. Non-childbearing<br> potential is defined as follows (by other than medical reasons):<br><br> *=45 years of age and has not had menses for >1 year<br><br> - Patients who have been amenorrhoeic for <2 years without history of a<br> hysterectomy and oophorectomy must have a follicle stimulating hormone value in<br> the postmenopausal range upon screening evaluation.<br><br> - Post-bilateral oophorectomy, or post-tubal ligation. Documented oophorectomy<br> must be confirmed with medical records of the actual procedure or confirmed by<br> an ultrasound. Tubal ligation must be confirmed with medical records of the<br> actual procedure, otherwise the patient must be willing to use 2 adequate<br> barrier methods throughout the study, starting with the screening visit through<br> 180 days after the last dose of study treatment. See Section 4.4 for a list of<br> acceptable birth control methods. Information must be captured appropriately<br> within the site's source documents.<br><br> - Note: Abstinence is acceptable if this is the established and preferred<br> contraception for the patient.<br><br> - Participant must agree to not breastfeed during the study or for 180 days after the<br> last dose of study treatment.<br><br> - Ability to understand and willingness to sign an IRB approved written informed<br> consent document (or that of legally authorized representative, if applicable).<br><br>Exclusion Criteria:<br><br> - Any prior treatment for endometrial cancer or currently receiving chemotherapy for<br> endometrial cancer.<br><br> - Evidence of metastatic disease outside of the cervix or uterus as determined on CT<br> or MRI.<br><br> - A history of other malignancy = 3 years previous with the exception of basal cell or<br> squamous cell carcinoma of the skin which were treated with local resection only.<br><br> - Previous treatment with an anti-PD-1, anti-PD-L1, or any PD-L2 drug.<br><br> - Known brain or leptomeningeal metastases. Patients with known brain metastases must<br> be excluded from this clinical trial because of their poor prognosis and because<br> they often develop progressive neurologic dysfunction that would confound the<br> evaluation of neurologic and other adverse events.<br><br> - A history of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to TSR-042 or other agents used in the study.<br><br> - Pregnant and/or breastfeeding. Women of childbearing potential must have a negative<br> pregnancy test within 7 days of study entry.<br><br> - Participant must not be simultaneously enrolled in any interventional clinical trial<br><br> - Participant must not have had major surgery = 3 weeks prior to initiating protocol<br> therapy and participant must have recovered from any surgical effects.<br><br> - Participant must not have received investigational therapy = 4 weeks, or within a<br> time interval less than at least 5 half-lives of the investigational agent,<br> whichever is shorter, prior initiating protocol therapy.<br><br> - Participant has had radiation therapy encompassing >20% of the bone marrow within 2<br> weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.<br><br> - Participant must not have a serious, uncontrolled medical disorder, nonmalignant<br> systemic disease, or active, uncontrolled infection. Examples include, but are not<br> limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial<br> infarction, chronic obstructive pulmonary disease, uncontrolled major seizure<br> disorder, unstable spinal cord compression, superior vena cava syndrome, or any<br> psychiatric disorder that prohibits obtaining informed consent.<br><br> - Patient experienced = Grade 3 immune-related AE with prior immunotherapy, with the<br> exception of non-clinically significant lab abnormalities.<br><br> - Participant has a diagnosis of immunodeficiency or has receiving systemic steroid<br> therapy or any other form of immunosuppressive therapy within 7 days prior to<br> initiating protocol therapy.<br><br> - Participant has a known history of human immunodeficiency virus (type 1 or 2<br> antibodies).<br><br> - Participant has known active hepatitis B (eg, hepatitis B surface antigen [HBsAg]<br> reactive) or hepatitis C (eg, hepatitis C virus [HCV] ribonucleic acid [qualitative]<br> is detected).<br><br> - Participant has an active autoimmune disease that has required systemic treatment in<br> the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or<br> immunomodulatory drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic<br> corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is<br> not considered a form of systemic treatment.<br><br> - Participant must not have a history of interstitial lung disease.<br><br> - Participant has received a live vaccine within 14 days of initiating protocol<br> therapy.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of the regimen as measured by the grade of toxicities experienced as assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS)