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New treatment option for Endometrial Cancer
Official title First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer
ClinicalTrials.gov ID: NCT06502743
What this study is testing
What is Nesuparib?
Nesuparib is an investigational medicine, being studied as a potential treatment for endometrial cancer.
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
- The goal of this study is listed below. Part A (Safety Run-in Phase) : To determine feasibility of pembrolizumab and nesuparib combination as maintenance therapy in patients with MMR-proficient advanced and recurrent endometrial cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, women only
You may be able to join if
- Patient must be female ≥ 19 years of age
- Histologic confirmation of the original primary tumor is required. Patients with the following histologic types are eligible: Endometrioid...
- Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease)...
- MMR proficient confirmed by institutional (local) MMR IHC testing.
- Patient must provide the institutional (local) P53 IHC result.
You likely can't join if
- Patient has undergone prior treatment with a known PARP inhibitor.
- Patient has a known hypersensitivity to nesuparib, pembrolizumab or combination cytotoxic chemotherapy components or excipients.
- MMR deficiency confirmed by institutional MMR IHC testing.
- Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and...
- Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may be...
- Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell...
See the full eligibility criteria
Who can join
- Patient must be female ≥ 19 years of age
- Histologic confirmation of the original primary tumor is required. Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell...
- Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
- MMR proficient confirmed by institutional (local) MMR IHC testing.
- Patient must provide the institutional (local) P53 IHC result.
- Prior Therapy;
- Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if provided adjuvant chemotherapy was completed ≥ 12 months prior to...
- Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or...
- Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to randomization.
- Archival tumor tissue available or a fresh biopsy must be obtained prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Have adequate organ function. Specimens must be collected within 7days prior to the start of study intervention. \- Hematology Absolute neutrophil count (ANC) ≥1,500/μL without growth factor support within 2 weeks...
- Kidney function Creatinine or measured or calculated creatinine clearance (GFR may also be used in place of creatinine or CrCl a) ≤1.5 × ULN or ≥30 mL/min for people with creatinine levels \>1.5 × institutional ULN.
- liver function Total bilirubin ≤1.5×ULN or direct bilirubin ≤ULN for people whose total bilirubin exceeds 1.5 times the normal value. AST (SGOT) and ALT (SGPT) ≤3 × ULN (≤5 × ULN in people with liver metastases)
- Coagulation International normalized ratio (INR) or prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5
- Thyroid function Thyroid stimulating hormone (TSH) within normal limits (WNL); In euthyroid people receiving thyroid replacement therapy, TSH \< ULN; If an abnormal TSH result is shown, free T4 is normal, and glandular...
- Patient has voluntarily agreed to participate by giving written informed consent/assent for the trial.
- Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal method or abstinence, contraceptive procedure (IUD, Mirena, etc.)) from up to 14 days prior to randomization (for oral...
- Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they...
- Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \<45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to...
- Have a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to randomization; OR Have a congenital or acquired condition that prevents...
What rules you out
- Patient has undergone prior treatment with a known PARP inhibitor.
- Patient has a known hypersensitivity to nesuparib, pembrolizumab or combination cytotoxic chemotherapy components or excipients.
- MMR deficiency confirmed by institutional MMR IHC testing.
- Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to...
- Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may be eligible if follow-up brain imaging after CNS directed therapy shows no...
- Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone...
- Patient has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
- Patients who have received steroids 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 patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.
- Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- Patient with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, noninfectious...
- Patient has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA [qualitative]) infection. Note: Testing for Hepatitis B or C is not required unless mandated by local...
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Patient has known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Patients with systemic autoimmune disease such as Systemic Lupus Erythematosus.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to be pregnant or conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of Paclitaxel +...
- Has had an allogenic tissue/solid organ transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Kyeonggi-do, South Korea
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kyeonggi-do, South Korea; Seoul, South Korea. 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.