[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-squamous-cell-carcinoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,60,91,113,158,184],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100609637","phase-1-a-study-evaluating-the-safety-efficacy-and-pharmacokinetics-pk-of-evolve104-in-participants-with-advanced-urothelial-and-squamous-cell-carcinomas-100609637",false,"NCT07217171","A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas","A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas","Key Inclusion Criteria:\n\nParticipants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma.\n\n1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.\n2. The cancer must be measurable by CT scan or MRI.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.\n4. Anticipated life expectancy of at least 3 months.\n5. Adequate organ function, as indicated by standard blood tests.\n6. Able to provide a fresh or archival tumor biopsy.\n7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile.\n\nKey Exclusion Criteria:\n\n1. The participant is a candidate for treatment with a targeted agent known to provide a benefit.\n2. Persistent significant toxicities from prior anticancer therapy.\n3. Brain metastases unless previously treated and stable.\n4. Prior severe or life-threatening immunologic reactions to previous therapies.\n5. Significant medical conditions, including but not limited to:\n\n   * History of clinically significant cardiac disease\n   * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.\n   * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.\n   * History of cirrhosis or significant portal hypertension.\n   * Uncontrolled or significant infection.\n   * History of certain other cancers in the past 3 years.\n   * History of arterial thrombosis, stroke and transient ischemic attack within 6 months.\n   * Active or uncontrolled HIV, HBV or HCV infection.\n   * Autoimmune or other condition requiring chronic systemic immunosuppression.","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.",[26,27,28,29,30,31,32,33,34,35,36],"Bladder Cancer","Squamous Cell Carcinoma of the Lung","Esophageal Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Cutaneous Squamous Cell Cancer","Penile Squamous Cell Carcinoma","Anal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Vaginal Squamous Cell Carcinoma","Urethral Squamous Cell Carcinoma",[38,39,40,41,42,43,44,45,46],"bladder","lung","esophagus","tongue","penile","anal","vulvar","cervical","vaginal","RECRUITING","2026-07-01",{"date":50,"type":51},"2026-07-02","ACTUAL",{"date":53,"type":51},"2025-11-13",{"date":55,"type":20},"2031-01-29",{"name":57,"class":58},"EvolveImmune United, Inc","INDUSTRY",12,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100605991","phase-1-a-study-to-investigate-alep03-as-monotherapy-in-adult-patients-with-selected-advanced-or-metastatic-cldn1-solid-tumors-100605991","NCT07169734","A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","Inclusion Criteria:\n\n* Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.\n* Have documented radiological disease progression at study entry.\n* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.\n\nPhase I Dose Escalation:\n\n\\- Received and being refractory\u002Fintolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.\n\nPhase I RDE and Phase II:\n\n* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.\n* Patients with actionable oncogenic drivers: received feasible targeted therapy.\n\nApplicable for Phase I Dose Escalation, Phase I RDE and Phase II:\n\n* Measurable disease per RECIST 1.1, as determined by the site.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.\n* Demonstrate adequate bone marrow and organ function as per the protocol.\n\nExclusion Criteria:\n\n* SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and\u002For immunosuppressive therapies.\n* Has clinically significant gastrointestinal bleeding.\n* Has an active infection requiring systemic treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.",{"count":68,"type":20},180,[23,70],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.",[34,73,74,75,76],"Squamous Non-small-cell Lung Cancer","Colorectal Cancer","Intrahepatic Cholangiocarcinoma","Urothelial Carcinoma",[78,79,80,81,82],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion",{"date":50,"type":51},{"date":85,"type":51},"2025-08-26",{"date":87,"type":20},"2029-10-04",{"name":89,"class":58},"Alentis Therapeutics AG",41,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":90},"100573538","phase-1-a-study-to-investigate-alep02-as-monotherapy-in-adult-patients-with-selected-cldn1-solid-tumors-100573538","NCT06747585","A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors","A Phase I\u002FII, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors","Inclusion Criteria:\n\n* Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.\n* Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Have provided tissue for CLDN1 analysis in a central laboratory.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Demonstrate adequate bone marrow and organ function.\n* Patients must have recovered from all toxicities led by prior treatment.\n* Have measurable disease based on RECIST 1.1 as determined by the site.\n\nExclusion Criteria:\n\n* Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).\n* Patients with uncontrolled diabetes.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.\n* Concomitant use of drugs that are known to prolong or shorten QT and\u002For have known risk of Torsades de Pointes.",{"count":99,"type":20},170,[23,70],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.",[73,103,34,28],"Head and Neck Squamous Cell Carcinoma",[78,79,80,81,82],"2026-06-26",{"date":107,"type":51},"2026-06-29",{"date":109,"type":51},"2024-12-16",{"date":111,"type":20},"2028-08-15",{"name":89,"class":58},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":131,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100509238","phase-1-a-phase-ibii-study-of-an-anti-her3-antibody-hmbd-001-with-cetuximab---docetaxel-in-advanced-squamous-cell-cancers-100509238","NCT05910827","A Phase Ib\u002FII Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +\u002F- Docetaxel in Advanced Squamous Cell Cancers","A Phase Ib\u002FII Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Ability to understand and be willing to sign an informed consent form\n\n  * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \\&gt; 18 years of age)\n  * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1\n  * Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable\n  * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,\n  * Have an estimated life expectancy of at least 3 months\n  * Participants must be willing to provide a fresh tumor biopsy sample\n  * Have adequate organ function\n  * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal\n  * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion\n\nExclusion Criteria:\n\n* Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C\n\n  * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and\u002For KRAS G12C mutation\n  * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \\&gt;2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and\u002For impact the study results e.g., alopecia\n  * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment\n  * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline\n  * Evidence of abnormal cardiac function\n  * History of uncontrolled allergic reactions and\u002For known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into\n  * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n  * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment\n  * Known Human Immunodeficiency Virus (HIV) infection\n  * Active hepatitis B or hepatitis C infection\n  * Pregnant or breast feeding\n  * COVID 19 infection within 3 months prior to the first dose of the study drug\n  * COVID 19 vaccination within 14 days prior to the first dose of the study drug\n  * Treatment with strong inhibitors or inducers of CYP3A4",{"count":121,"type":20},398,[23,70],"This is a Phase Ib\u002FII multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers",[125,126,127,34,128,129,130],"Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Esophageal Squamous Cell Carcinoma","Advanced Cutaneous Squamous Cell Carcinoma","Nasopharyngeal Cancinoma (NPC)","Squamous Cell Carcinoma",[132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147],"NSCLC","Non-small Cell Lung Cancer","sqNSCLC","Lung","Squamous","HER3","ErbB3","Docetaxel","Cetuximab","cervical squamous cell carcinoma","HNSCC","CSCC","ESCC","advanced squamous cell cancer","NPC","SCC","2026-05-24",{"date":150,"type":51},"2026-05-27",{"date":152,"type":51},"2024-02-05",{"date":154,"type":20},"2027-12",{"name":156,"class":58},"Hummingbird Bioscience",20,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":183},"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":166,"type":20},35,[23,70],"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.",[170,171,34,172],"Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Stage IVB Cervical Cancer American Joint Committee on Cancer (AJCC) v8","2025-08-12",{"date":175,"type":51},"2025-08-15",{"date":177,"type":51},"2025-07-29",{"date":179,"type":20},"2032-01-31",{"name":181,"class":182},"Jonsson Comprehensive Cancer Center","OTHER",4,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":191,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":195,"studyType":196,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":199,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100437454","study-of-nimotuzumab-combined-with-imrt-in-elder-patients-with-cervical-squamous-cell-carcinoma-100437454","NCT04976478","Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma","A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age≥65 years old\n2. Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)\n3. At least one measurable lesion according to RECIST 1.1 guideline\n4. Patients are intolerant to or refuse chemotherapy.\n5. No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:\n\n   Hemoglobin ≥90g\u002FL Absolute count of neutrophils≥2×109\u002FL orwhite blood cell count≥4.0×109\u002FL； Platelet count≥100×109\u002FL； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；\n\n   Serum creatinine≤1.5×ULN or CrCl\\> 60 mL\u002Fmin(according toCockcroft-Gault):\n\n   Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 \u002F (72×Scr mg\u002Fdl)\n6. ECOG score 0-2\n7. Expectancy of life is at least 3 months.\n8. Eligible for pelvic MRI examination.\n9. The patients voluntarily received nimotuzumab combined with radiotherapy.\n10. Patients can comply with the protocol and are willing to sign informed consent.\n\nExclusion Criteria:\n\n1. Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy\n2. Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.\n3. Patients with rectovaginal fistula\u002Fvaginovesical fistula\u002Funcontrolled vaginal bleeding or with fistula risk.\n\n.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.\n\n7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.\n\n8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.\n\n11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.\n\n12)Other factors were assessed by investigators to be unsuitable to this study.","FEMALE","65 Years",{"count":194,"type":20},125,"3 Years","OBSERVATIONAL","To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma",[34],"NOT_YET_RECRUITING","2021-07-21",{"date":202,"type":51},"2021-07-26",{"date":204,"type":20},"2021-07",{"date":206,"type":20},"2026-12",{"name":208,"class":182},"Peking University Third Hospital",1]