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Tests treatment safety and results for Endometrial Cancer
Official title Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
ClinicalTrials.gov ID: NCT05819892
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as Taxol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients are eligible to participate on this study only if they meet all of the following .
- Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures
- Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation...
- Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
- Age ≥ 18 years
You likely can't join if
- Patients are not eligible to participate on this study if they meet any of the following exclusion criteria.
- Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs.
- Surgery ≤ 3 weeks prior to initiating protocol therapy Investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives...
- Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
- Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients.
- Have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive...
See the full eligibility criteria
- Patients are eligible to participate on this study only if they meet all of the following .
- Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures
- Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total...
- Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
- Age ≥ 18 years
- Performance Status of ECOG 0 or 1 (see Performance Status Criteria)
- Adequate hematologic function within 14 days prior to enrollment defined as follows:
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100,000/mcl
- Absolute neutrophil count (ANC) ≥ 1,500/mcl
- Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine ≤ 2 x laboratory upper limit of normal (ULN) or CrCl ≥60ml/min
- Adequate hepatic function within 14 days prior to enrollment defined as follows:
- Bilirubin ≤ 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level ≤ 2 x ULN may be enrolled)
- ALT and AST ≤ 2.5 x ULN
- Adequate coagulation within 14 days prior to enrollment defined as INR or PT/aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of...
- Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial (i.e...
- Patients are not eligible to participate on this study if they meet any of the following exclusion criteria.
- Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs.
- Surgery ≤ 3 weeks prior to initiating protocol therapy Investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating...
- Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
- Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients.
- Have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is...
- History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
- Have a diagnosis of immunodeficiency or are receiving daily systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment:
- Steroids received as CT scan contrast premedication may be enrolled.
- The use of inhaled or topical corticosteroids is allowed.
- The use of mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency is allowed.
- The use of physiologic doses of corticosteroids may be allowed and in consultation with the study chair (e.g. 10 mg of prednisone used for replacement therapy for adrenal insufficiency).
- Have received a live vaccine within 30 days of starting trial therapy.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. --Evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load, tested positive for the...
- Uncontrolled intercurrent illness including (but not limited to): ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis...
- Have received any of the prohibited medications listed in Section 7.2.
- Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Asymptomatic brain metastases (i.e, off corticosteroids and anticonvulsants for at least 7...
- Known human immunodeficiency virus (HIV)-infected patients.
- Women of childbearing potential (WoCBP) who have been not been permanently or surgically sterilized and are capable of procreation
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.