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New treatment option for Endometrial Adenocarcinoma
Official title Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
ClinicalTrials.gov ID: NCT05112601
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial adenocarcinoma.
Also referred to as Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016.
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
- This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 with measurable or non-measurable (detectable) recurrent endometrial cancer
- Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that...
- Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but...
- All other lesions (or sites of disease), including small lesions (longest diameter \ = 10 to \< 15 mm short axis), are considered non-measurable...
- Ascites and/or pleural effusion attributed to tumor
You likely can't join if
- Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
- Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or...
- Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
- Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent
- Patients on immunosuppressive therapy, with the exception of:
- Intra-nasal, inhaled, topical or local steroid injections
See the full eligibility criteria
Who can join
- Patients with measurable or non-measurable (detectable) recurrent endometrial cancer
- Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter...
- Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:
- All other lesions (or sites of disease), including small lesions (longest diameter \ = 10 to \< 15 mm short axis), are considered non-measurable disease
- Ascites and/or pleural effusion attributed to tumor
- Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
- Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair...
- Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal"...
- Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous...
- Patients may have received 1-2 prior lines of systemic therapy:
- Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease...
- 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...
- Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration
- Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to...
- Age \>= 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Platelets \>= 100,000/mcl
- Absolute neutrophil count (ANC) \>= 1,500/mcl
- Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN)
- Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\<3 x ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN
- Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia \< grade 2 within 28 days prior to registration)
- Thyroid-stimulating hormone (TSH) within normal limits (TSH \< ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated
- Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery
- As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York...
- The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree...
- WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12...
- Patients with a 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...
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
- Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one...
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal...
- Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
- Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid...
What rules you out
- Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
- Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities
- Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
- Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent
- Patients on immunosuppressive therapy, with the exception of:
- Intra-nasal, inhaled, topical or local steroid injections
- Premedication for hypersensitivity reaction
- Patients with 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, should be...
- Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
- Patients with 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...
- Women who are pregnant or unwilling to discontinue nursing
- Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Athens, Georgia, United States
- Augusta, Georgia, United States
- Boise, Idaho, United States
- Caldwell, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- Normal, Illinois, United States
- Urbana, Illinois, United States
- Carmel, Indiana, United States
- Crown Point, Indiana, United States
- Dyer, Indiana, United States
+ 90 more site(s).
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 Birmingham, Alabama, United States; Athens, Georgia, United States; Augusta, Georgia, United States; Boise, Idaho, United States; Caldwell, Idaho, United States; Coeur d'Alene, Idaho, United States and 104 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.