[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-adenosquamous-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-adenosquamous-carcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,83,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627900","phase-1-ava6103-in-subjects-with-locally-advanced-or-metastatic-selected-solid-tumors-100627900",false,"NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.","ALL","18 Years",{"count":20,"type":21},174,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[27,28,29,30,31,32,33,34,35],"Vulvar Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Colorectal Cancer","Hormone Receptor Positive Breast Carcinoma","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-02","ACTUAL",{"date":42,"type":40},"2026-03-31",{"date":44,"type":21},"2030-06",{"name":46,"class":47},"Avacta Life Sciences Ltd","INDUSTRY",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100614189","phase-2-hypofractionated-radiotherapy-for-the-treatment-of-locally-advanced-cervical-cancer-in-uganda-100614189","NCT07276360","Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda","Phase II Randomized Non-Inferiority Trial of Hypofractionated Radiotherapy for Locally Advanced Cervical Cancer in Uganda","HypoRTCx-UG","Inclusion Criteria:\n\n* Females aged 18 years or older\n* Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment\n* Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC\n* Able to provide written informed consent in English, Luganda, Runyankole, or Lango\n* Willing to attend post-treatment follow-up for up to 12 months\n* Fit for concurrent chemotherapy with cisplatin\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2\n* Absolute neutrophil count ≥ 1,500 cells\u002Fmm\\^3 (1.5 x 10\\^9\u002FL)\n* Platelets ≥ 100,000 cells\u002Fmm\\^3 (100 x 10\\^9\u002FL)\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Leukocyte count ≥ 4,000 cells\u002Fmm\\^3 (4.0 x 10\\^9\u002FL)\n* Creatinine clearance \\> 60 mL\u002Fmins, calculated using the Cockcroft-gault equation for women\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 times the upper limit of normal (ULN)\n* Total bilirubin \\\u003C 2 x ULN unless attributed to the use of antiretroviral therapy (ART)\n* HIV-positive participants must be on a stable ART regimen for at least 6 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention\n* Clinical and\u002For radiological evidence of distant metastases\n* Prior pelvic or abdominal radiotherapy\n* Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment\n* History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment\n* Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated\n* Concurrent untreated invasive malignancy\n* Uncontrolled concurrent medical\u002Fpsychiatric diagnosis that would limit compliance with study requirements\n* Uncontrolled HIV infection, especially HIV viral load \\> 2,000 copies\u002FmL\n* Participants with CD4 counts \\\u003C 200 cells\u002Fmm\\^3","FEMALE",{"count":59,"type":21},278,[61],"PHASE2","This phase II trial compares the effect of hypofractionated radiotherapy (HFRT) to conventional fractionated radiotherapy (CFRT) when given in combination with cisplatin and brachytherapy in patients with stage IB3, II, or III cervical cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. CFRT delivers the total dose of radiation over the amount of time according to standard practice. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. HFRT shortens treatment duration and may reduce costs and may improve the completion rates. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HFRT may be safe, tolerable, and\u002For as effective as CFRT when given in combination with cisplatin and brachytherapy in treating patients with stage IB3, II or III cervical cancer.",[64,65,31,66,32],"Cervical Cancer","Cervix Cancer","Cervical Small Cell Carcinoma",[68,69,70,71],"Cervical cancer","Radiotherapy","Hypofractionation","Uganda","2026-03-26",{"date":74,"type":40},"2026-03-27",{"date":76,"type":40},"2026-03-11",{"date":78,"type":21},"2029-01-02",{"name":80,"class":81},"Uganda Cancer Institute","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":5},"100557858","phase-1-external-beam-radiation-therapy-and-brachytherapy-with-chemotherapy-and-immunotherapy-for-the-treatment-of-stage-ivb-cervical-cancer-100557858","NCT06543576","External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer","A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer","Inclusion Criteria:\n\n* Participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage IVB cervical cancer will be enrolled in this study\n* Patients with stage IVB adenocarcinoma, adenosquamous carcinoma, or squamous-cell carcinoma of the cervix that has not yet been treated with systemic chemotherapy or radiation therapy\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible\n* The participant provides written informed consent for the trial\n* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue\n* Patients must have PD-L1 status, CPS score of over 1. PD-L1 status will be determined per institutional standards via the Food and Drug Administration (FDA)-approved test, Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx kit with combined positive score (CPS) interpretation\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\nHepatitis B screening tests are not required unless:\n\n* Known history of HBV infection\n* As mandated by local health authority\n\n  * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Hepatitis C screening tests are not required unless:\n\n* Known history of HCV infection\n* As mandated by local health authority\n\n  * HIV-infected participants must have well-controlled HIV on antiretroviral treatment (ART), defined as:\n* Participants on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 at the time of screening\n* Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n* It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n* Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study\n* The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002FµL (collected within 10 days prior to the start of study)\n  * Platelets ≥ 100 000\u002FµL (collected within 10 days prior to the start of study)\n  * Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (collected within 10 days prior to the start of study). Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n  * Creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 × institutional ULN (collected within 10 days prior to the start of study)\n* Creatinine clearance (CrCl) should be calculated per institutional standard\n\n  * Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN (collected within 10 days prior to the start of study)\n  * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) (collected within 10 days prior to the start of study)\n  * International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (collected within 10 days prior to the start of study)\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)\n* Has received prior hysterectomy. (Prior lymphadenectomy permitted)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to \u002Fallocation\n* Has received prior radiotherapy for cervical cancer\n* 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\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤ 6, and prostate specific antigen (PSA) \\\u003C 10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded\n* Has known active carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n* Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]) infection.\n\nNote: Testing for Hepatitis B or C is not required unless mandated by local health authority\n\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* 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 duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease",{"count":91,"type":21},35,[24,61],"This phase I\u002FII trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.",[31,32,95,96],"Cervical Squamous Cell Carcinoma","Stage IVB Cervical Cancer American Joint Committee on Cancer (AJCC) v8","2025-08-12",{"date":99,"type":40},"2025-08-15",{"date":101,"type":40},"2025-07-29",{"date":103,"type":21},"2032-01-31",{"name":105,"class":81},"Jonsson Comprehensive Cancer Center",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":82},"100578020","phase-2-pembrolizumab-concurrent-with-and-following-carbon-ion-radiotherapy-for-locally-advanced-cervical-adenocarcinoma-100578020","NCT06805864","Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma","Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma (BROTHER STUDY)","BROTHER","Inclusion Criteria:\n\n* 1\\. Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed adenocarcinoma or adenosquamous carcinoma of the uterine cervix and Stage ⅡA2, ⅡB, ⅢA, ⅢB, ⅢC1r, IVA according to FIGO classification (2018) will be enrolled in this study.\n\n  2\\. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n\n  3\\. Have measurable disease based on RECIST 1.1.\n\n  4\\. Archival tumor tissue sample or a newly obtained biopsy of a tumor lesion that was not previously irradiated was provided. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsy samples are preferred to archived tissues.\n\n  5\\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of pembrolizumab.\n\n  6\\. Have adequate organ function below. Specimens must be collected within 10 days to the start of pembrolizumab administration.\n* Absolute neutrophil count (ANC) ≥ 1500\u002FµL, Platelets ≥ 100000\u002Fµ, Hemoglobin ≥9.0 g\u002FdL or ≥ 5.6 mmol\u002FL, Creatinine clearance ≥ 50 mL\u002Fmin, Total bilirubin ≤1.5 ×ULN or direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN, AST and ALT ≤2.5 × ULN, International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n\nExclusion Criteria:\n\n* 1\\. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n\n  2\\. Has received prior radical surgery, RT, or systemic therapy (including investigational drugs) for cervical cancer. Note: Conization for localized cervical tumors is allowed.\n\n  3\\. 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.\n\nNote: please refer to Section 5.3 for information on COVID-19 vaccines\n\n4\\. Has received an investigational agent or has used an investigational device within 4 weeks prior to pembrolizumab administration.\n\n5\\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.\n\n6\\. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n\n7\\. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n\n8\\. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g.., thyroxine, insulin, or physiologic corticosteroid).\n\n9\\. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n\n10\\. Has an active infection requiring systemic therapy.\n\n11\\. History of active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]) infection.\n\n12\\. 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 duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n\n13\\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n14\\. Is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n\n15\\. Has had an allogenic tissue\u002Fsolid organ transplant.\n\n16\\. History of HIV infection.",{"count":115,"type":21},45,[61],"The goal of this clinical trial is to learn if pembrolizumab works for cervical adenocarcinoma treat with concurrent chemo-carbon-ion radiaotherapy (CIRT).\n\nThe main questions it aims to answer are:\n\n• Does concurrent chemo-CIRT with pembrolizumab improves 2-year progression-free survival (PFS), compared with concurrent chemoradiotherapy with conventional X-rays?",[31,32],[64,120,121],"Carbon-ion Radiotherapy","Pembrolizumab","NOT_YET_RECRUITING","2025-01-28",{"date":125,"type":40},"2025-02-03",{"date":127,"type":21},"2025-02-01",{"date":129,"type":21},"2030-12-31",{"name":131,"class":81},"Gunma University"]