[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-head-and-neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-head-and-neck-squamous-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,45,69,95,137,181,215,238,285,314,353,387,416,437,457,480,502,535,554,591],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100414059","phase-2-testing-what-happens-when-an-immunotherapy-drug-pembrolizumab-is-given-by-itself-compared-to-the-usual-treatment-of-chemotherapy-with-radiation-after-surgery-for-recurrent-head-and-neck-squamous-cell-carcinoma-100414059",false,"NCT04671667","Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma","A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent\u002FSecond Primary Head and Neck Squamous Cell Carcinoma With High Risk Features","Inclusion Criteria:\n\n* Patient must be between 18 and 79 years of age\n* Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field\n* Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery\n* Patients must have high risk disease defined as:\n\n  * Positive margins and\u002For extra nodal extension (ENE)\n\n    * Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive\n    * ENE may be either gross or microscopic\n* Patient must have a PD-L1 Combined Positive Score (CPS) \\>= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC\n* Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as \\> 50% of the presurgical tumor volume having previously received a dose of \\> 45 Gy as determined by the treating radiation oncologist\n* Patient must have completed prior radiation a minimum of 6 months prior to randomization\n* Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization\n* Patient must not have received anti-PD-1\u002FPD-L1 therapy for recurrent disease. If the patient received anti-PD-1\u002FPD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1\u002FPD-L1 therapy must have been given greater than one year prior to randomization\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility\u002Frandomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is someone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (obtained =\\\u003C 28 days prior to protocol randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 28 days prior to protocol randomization)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (obtained =\\\u003C 28 days prior to protocol randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional ULN (obtained =\\\u003C 28 days prior to protocol randomization)\n* Creatinine clearance \\> 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained =\\\u003C 28 days prior to protocol randomization)\n* Patient must not have a current active infection that requires systemic treatment at time of randomization\n* Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization\n* Patient must not have a history of solid organ transplant or stem cell transplant\n* Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =\\\u003C 10 mg\u002Fday of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* 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 Heart Association Functional classification. Patients with New York Heart Association class III or IV heart failure are not eligible\n* Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed\n* Patient must not have severe hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* Patient must not have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and\u002For multicentric Castleman disease\n* Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection\n\n  * NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority","ALL","18 Years","79 Years",{"count":20,"type":21},188,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \\[cisplatin and carboplatin\\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.",[27,28,29,30,31],"Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2021-04-27",{"date":40,"type":21},"2029-06-30",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",178,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100609388","phase-1-phase-i-ii-trial-combining-pd-1-inhibition-and-neoadjuvant-proton-or-photon-radiation-therapy-in-recurrent-head-and-neck-squamous-cell-carcinoma-100609388","NCT07213934","Phase I\u002F II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma","WOPPPR: Window of Opportunity Phase I and Phase II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria (Both Phase I and Phase II)\n\n1. Patients must have histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma including oral cavity, laryngeal, hypopharyngeal, or oropharyngeal (HPV-) SCC.\n2. Patients must be a candidate for salvage surgical resection.\n3. Patients must have failed prior RT \\>6 months prior to recurrence with at least 30 Gy delivered to the current target volume.\n4. Disease must be limited to a single site or adjacent sites that can be treated in a single contiguous target volume for which the maximum total tumor dimension (GTV) must be \\\u003C7 cm.\n5. Patients must have a CPS PD-L1 of ≥1%. This may be tested on a new biopsy or archival tissue.\n6. Age ≥18 years.\n7. ECOG performance status ≤1 (or Karnofsky ≥70%, see Appendix A).\n8. Patients must have adequate organ and marrow function as defined below:\n\n   Platelets ≥100,000\u002FmcL Total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Creatinine ≤ 1.5x institutional upper limit of normal (ULN) OR glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m2 (see Appendix B).\n9. Archival tissue must be available for baseline analysis. Either a tumor block or at least 20 slides must be available.\n10. Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n11. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n13. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n14. 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 Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n15. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of pembrolizumab administration.\n16. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria (Phase I \\& II)\n\n1. Patients who have metastatic disease.\n2. Patients who have ongoing adverse events from prior anti-cancer therapy that would preclude completion of the proposed study treatment at the opinion of the treating investigators.\n3. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.\n4. Prior treatment with PD-1 inhibitors in the last 6 months or progression on a PD-1 inhibitor at any time.\n5. Autoimmune disease or other pro-inflammatory conditions other than treated stable asthma, minor allergies (such as seasonal allergies), vitiligo or hypothyroidism.\n6. Active and ongoing steroid use \\>10 mg prednisone, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, COPD, allergic rhinitis).\n7. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.\n8. Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with breastfeeding should be discontinued if the mother is treated with pembrolizumab.",{"count":53,"type":21},40,[55,24],"PHASE1","The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC).\n\nThe purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).",[58,27],"Head and Neck Cancer","2026-06-29",{"date":33,"type":36},{"date":62,"type":36},"2025-10-08",{"date":64,"type":21},"2031-12",{"name":66,"class":67},"University of Cincinnati","OTHER",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100495068","phase-2-preoperative-pembrolizumab-and-chemotherapy-in-resectable-recurrent-hnscc-100495068","NCT05726370","Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC","A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field, defined as \\>50% of the presurgical tumor volume having prior radiation dose of \\>45 Gy as determined by the treating radiation oncologist (including primary sites, such as oral cavity, oropharynx, larynx or hypopharynx carcinoma).\n* Participants must be a candidate for curative intent surgery.\n* Participants must have documented time of ≥ 6 months from completion of prior curative intent treatment for HNSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field.\n* Participants must be willing to undergo a mandatory pre-treatment biopsy and willing to provide blood and tissue from the pre-treatment biopsy and at the time of surgery. Exceptions may be made after discussion with sponsor if it is not medically feasible to obtain a pre-treatment biopsy or is in the best interest of the patient. Archival tissue may be collected in this situation. Participants will be offered the opportunity to volunteer for optional biopsies at the time of recurrence of disease.\n* Participants may have any smoking history (no restrictions)\n* Participants may have any Human Papilloma Virus (HPV) status of the tumor. Patients with oropharyngeal cancer are required to undergo HPV testing with p16 immunohistochemistry and\u002For confirmatory HPV PCR or ISH testing\n* Age ≥18 years\n* ECOG performance status 0 or 1 (Karnofsky ≥70%, see Appendix A)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2.\n* Participants 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 Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Because pembrolizumab and chemotherapy can be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  * a. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR\n  * b. A WOCBP who agrees to follow the contraceptive guidance in Appendix B during the treatment period and for at least 180 days after the last dose of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Sinonasal, nasopharyngeal or cutaneous primary site of squamous cell carcinoma of the head and neck\n* Has known distant metastatic disease. Those with known brain metastases should be excluded from this clinical trial, because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic\n* Has had chemotherapy or radiotherapy for HNSCC in curative intent setting within 6 months prior to entering the study.\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 a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\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* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has a history of allergic reactions to agents used in study\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\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* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or 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* Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to study registration (see Appendix B). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because pembrolizumab and chemotherapy agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab and chemotherapy, breastfeeding should be discontinued if the mother is treated on this protocol.",{"count":77,"type":21},28,[24],"This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery.\n\nThe names of the study drugs involved in this research study are:\n\n* pembrolizumab (a type of immunotherapy)\n* docetaxel (a type of chemotherapy)\n* cisplatin (a type of chemotherapy)\n* carboplatin (a type of chemotherapy)",[81,58,82,27,83],"Head and Neck Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","Second Primary Squamous Cell Carcinoma of the Head and Neck",[81,58,82,27,83],"2026-06-21",{"date":87,"type":36},"2026-06-23",{"date":89,"type":36},"2023-05-20",{"date":91,"type":21},"2030-05-20",{"name":93,"class":67},"Dana-Farber Cancer Institute",2,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":68},"100624088","phase-4-morning-versus-afternoon-administration-of-immunotherapy-for-the-treatment-of-advanced-or-metastatic-solid-tumors-the-knight-shift-study-100624088","NCT07405086","Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study","Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study","Inclusion Criteria:\n\n* Must provide written informed consent before any study-specific procedures or interventions are performed\n* Aged ≥ 18 years\n* Histologically confirmed advanced\u002Fmetastatic solid tumor as follows:\n\n  * Non small cell lung cancer (NSCLC) (driver-negative, immune checkpoint inhibitor \\[ICI\\]-eligible)\n  * Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (platinum-eligible),\n  * Renal cell carcinoma (RCC)\n  * Biliary-tract cancer (BTC)\n  * Hepatocellular carcinoma (HCC)\n  * Melanoma\n* Planned to receive a Food and Drug Administration (FDA)-approved immune check point inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) regimen for the treatment of their malignancy\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n\nExclusion Criteria:\n\n* Prior ICI-based regimen for treatment of cancer\n* Current or prior use of immunosuppressive medication within 28 days before planned standard-of-care immunotherapy infusion, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses not exceeding 10 mg\u002Fday of prednisone (or equivalent corticosteroid)\n* Uncontrolled autoimmune disease requiring immunosuppression\n* Active, uncontrolled central nervous system (CNS) metastases",{"count":103,"type":21},160,[105],"PHASE4","This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 11:00 am) or afternoon (12:00pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,27,122,123,124,125,126,127],"Advanced Biliary Tract Carcinoma","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Lung Non-Small Cell Carcinoma","Advanced Malignant Solid Neoplasm","Advanced Melanoma","Advanced Renal Cell Carcinoma","Metastatic Biliary Tract Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","2026-06-10",{"date":130,"type":36},"2026-06-12",{"date":132,"type":36},"2026-06-08",{"date":134,"type":21},"2028-12-31",{"name":136,"class":67},"OHSU Knight Cancer Institute",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":68},"100604954","phase-1-testing-the-addition-of-an-anti-cancer-drug-camonsertib-to-radiation-therapy-for-recurrent-head-and-neck-squamous-cell-carcinoma-100604954","NCT07156227","Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma","Phase I Trial of ATR Inhibitor Camonsertib Combined With Stereotactic Body Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed recurrent or metachronous (second primary) unresectable head and neck squamous cell carcinoma involving the oral cavity, oropharynx, larynx, hypopharynx, and\u002For paranasal sinus, or cervical lymphadenopathy with unknown primary. Core needle biopsy (preferably at least three 18-gauge cores) or incisional biopsy is preferred over fine needle aspiration (FNA) for diagnosis of recurrent disease or new primary head and neck squamous cell carcinoma to provide sufficient tumor tissue for correlative studies. Unresectable refers both to patients who have declined surgery and patients deemed unresectable by otolaryngology. This includes patients for whom curative resection is medically contraindicated and\u002For would be associated with excessive surgical risk (as deemed by the consulting otolaryngologist) or undue surgical morbidity (e.g., total glossectomy, laryngectomy, and\u002For major resection requiring free flap reconstruction). There are no requirements related to prior systemic therapies that patients may have received\n* Patients must have recurrent disease within a previously irradiated area (radiotherapy to dose ≥ 30 gray \\[Gy\\] and ≤ 80 Gy; in-field recurrence)\n* Patients must have completed prior radiotherapy at least 6 months prior to enrollment. Due to safety concerns, reirradiation within less than 6 months to the head and neck is very rarely recommended per standard of care\n* Patients must have measurable disease (at least one measurable lesion) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Baseline imaging must include neck CT (preferably contrast-enhanced) and chest CT or skullbase to midthigh PET\u002FCT (preferably with contrast-enhanced neck CT if diagnostic contrast-enhanced neck CT not available). Patients who have undergone surgery aside from biopsy may be included if gross disease is present within the surgical resection bed or at another site\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of camonsertib in combination with radiotherapy in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Leukocyte count ≥ 3,000\u002FmcL\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL without transfusion or erythropoietin dependency (within 7 days of assessment)\n* Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (if total serum bilirubin \\> 1.5 × institutional ULN, then direct bilirubin must be \\\u003C ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Albumin \\> 2.5 mg\u002FdL\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n\n  * GFR can be measured directly or estimated using the site's institutional standards\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* 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\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* 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 Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Ability to take pills by mouth\n* The effects of camonsertib on the developing human fetus are unknown. For this reason and because ATR inhibitors and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of camonsertib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia\n* Patients who are receiving any other investigational agents for a current cancer diagnosis\n* Patients with distant metastatic disease\n* Patients who have received more than one prior course of head and neck radiotherapy overlapping the region to be treated with the current diagnosis of head and neck cancer\n* Patients who have disease surrounding \\> 180 degrees of the carotid artery\n* Patients with tumors invading the mandible or tumors with gross skin involvement (i.e., tumor ulceration through the skin)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to camonsertib or radiation\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because camonsertib is an ATR inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with camonsertib, breastfeeding should be discontinued if the mother is treated with camonsertib. These potential risks may also apply to other agents used in this study\n* Patients diagnosed with scleroderma\n* Concomitant use of strong CYP3A4\u002F5 inhibitors and inducers, and strong P-gp and BCRP inhibitors\n\n  * Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product",{"count":145,"type":21},39,[55],"This phase I trial tests the safety, side effects, and best dose of camonsertib in combination with stereotactic body radiation therapy in controlling disease in patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that cannot be removed by surgery (unresectable). Camonsertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck squamous cell cancers.",[149,27,28,29,30,31,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173],"Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Recurrent Paranasal Sinus Squamous Cell Carcinoma","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Sinonasal Cancer AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Sinonasal Cancer AJCC v8","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hypopharyngeal Squamous Cell Carcinoma","Unresectable Laryngeal Squamous Cell Carcinoma","Unresectable Oral Cavity Squamous Cell Carcinoma","Unresectable Oropharyngeal Squamous Cell Carcinoma","Unresectable Paranasal Sinus Squamous Cell Carcinoma",{"date":175,"type":36},"2026-06-11",{"date":177,"type":21},"2027-02-13",{"date":179,"type":21},"2029-05-31",{"name":42,"class":43},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100561410","phase-3-testing-the-addition-of-anti-cancer-drug-cetuximab-to-standard-of-care-treatment-pembrolizumab-for-returning-or-spreading-head-and-neck-cancer-after-previous-treatment-100561410","NCT06589804","Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment","Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab\u002FCetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease","Inclusion Criteria:\n\n* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).\n* Previously untreated for recurrent and\u002For metastatic disease incurable by local therapies.\n* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.\n\n  * Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.\n* Measurable disease.\n* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.\n* Patient must have a combined positive score PD-L1 positive (CPS \\>\u002F= 1) tumor.\n* Any radiation therapy must be completed \\>= 10 days prior to registration.\n* Patients should not have received any prior treatment in the recurrent or metastatic setting.\n* Prior therapy with neoadjuvant or induction anti PD-1\u002FPD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \\>= 26 weeks prior to registration without evidence of disease progression during that treatment period.\n* Patient has not received a live vaccine within 30 days prior to registration.\n* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).\n* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.\n* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and\u002For HPV in situ hybridization (ISH).\n\n  * Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.\n* Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3.\n* Platelet count ≥ 100,000\u002Fmm\\^3.\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL (if \\\u003C 9 g\u002FdL, then transfusions are acceptable to increase hemoglobin above 9 g\u002FdL).\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula for participant with creatinine levels \\> 1.5 x institutional ULN.\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \\\u003C ULN for participant with total bilirubin \\> 1.5 x institutional ULN.\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x ULN unless liver metastases are present in which case \\\u003C 5.0 x ULN.\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* For treated\u002Fstable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\n  * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* 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.\n* 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 Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Patients does not have a history of active myocarditis.\n* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.\n* Patient does not have a history of solid organ transplantation.",{"count":189,"type":21},158,[191],"PHASE3","This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and\u002For that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and\u002For metastatic HNSCC than pembrolizumab alone.",[116,194,195,196,197,27,28,29,198,30,31,199,200,201,202,203,157,204,205,206,207],"Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Recurrent Neck Squamous Cell Carcinoma of Unknown Primary","Refractory Head and Neck Squamous Cell Carcinoma","Refractory Hypopharyngeal Squamous Cell Carcinoma","Refractory Laryngeal Squamous Cell Carcinoma","Refractory Oral Cavity Squamous Cell Carcinoma","Refractory Oropharyngeal Squamous Cell Carcinoma","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8",{"date":175,"type":36},{"date":210,"type":36},"2025-03-27",{"date":212,"type":21},"2029-11-30",{"name":42,"class":43},177,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":230,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":94},"100534468","phase-2-pd-l1-t-hank-nai-il-15sa-and-cetuximab-for-recurrent-metastatic-hnscc-100534468","NCT06239220","PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC","A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)","Inclusion Criteria:\n\n* Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R\u002FM) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.\n* Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.\n* Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R\u002FM HNSCC; one of these lines should have included anti-PD-1\u002FL1 therapy.\n\n  * a.Platinum-based therapy as part of definitive\u002Fadjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.\n  * b. At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (2 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE v5 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or peripheral neuropathy).\n* Be ≥18 years of age on the day of signing informed consent.\n* Must provide prior documentation on tumor PD-L1 expression status and HPV status (for oropharyngeal cancer cases), if available from the medical record.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).\n* Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration):\n\n  * a. ANC ≥1,000\u002FmcL\n  * b. Hemoglobin ≥9 g\u002FdL\n  * c. Platelets ≥100,000\u002FmcL\n  * d. Total bilirubin ≤ upper limit of normal (ULN)\n  * e. AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x institutional ULN if concomitant with alkaline phosphatase \\>2.5x institutional ULN) or ≤5x ULN for those with liver metastases\n  * g. Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5x ULN\n* Baseline tumor measurements must be documented from imaging within 28 days prior to study registration.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects should not become pregnant or nurse a baby during the study and through 120 days after the last dose of study drugs. Male subjects should use a condom as a contraceptive during the study and through 120 days after the last dose of study drugs.\n\nSperm donation is discouraged for up to 6 months after the last dose of study drug.\n\n-Be willing and able to provide written informed consent for the trial.\n\nExclusion Criteria\n\n* Have been previously treated with 3 or more lines of systemic therapy for R\u002FM HNSCC.\n* Have received radiation therapy (RT) within 10 days of starting protocol therapy.\n* Solid organ transplant (allograft) recipients.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 3 weeks prior to study registration) and have no evidence of new or enlarging brain metastases.\n* A history of significant autoimmune disease as judged by the treating investigator and on active therapy including prednisone ≥10 mg daily dose equivalent of corticosteroids.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection; evidence of symptomatic congestive heart failure, unstable angina pectoris, stroke, or ventricular arrhythmia within 6 months of enrollment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions might include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Any known positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). Patients with HIV are eligible if their plasma HIV viral load is undetectable at baseline on antiretroviral therapy.\n* Subjects who are pregnant, or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.",{"count":223,"type":21},25,[24],"The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer.\n\nThe names of the therapies involved in this study are:\n\n* PD-L1 t-haNK cell therapy (a NK cell therapy infusion)\n* NAI (a type of recombinant human superagonist)\n* Cetuximab (a type of antibody)",[58,81,227,228,229,27],"Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer","Metastatic Head-and-neck Squamous-cell Carcinoma",[58,81,227,228,229,27],{"date":175,"type":36},{"date":233,"type":36},"2024-02-16",{"date":235,"type":21},"2027-01-31",{"name":237,"class":67},"Glenn J. Hanna",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":68},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":246,"type":21},50,[24],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[250,114,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,116,267,268,27,269,124,270,271,127,272,273,274,275],"Advanced Esophageal Squamous Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Gastroesophageal Junction Adenocarcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Renal Cell Carcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Urothelial Carcinoma","Unresectable Urothelial Carcinoma","2026-06-05",{"date":278,"type":36},"2026-06-09",{"date":280,"type":36},"2024-04-30",{"date":282,"type":21},"2026-12-31",{"name":284,"class":67},"Mayo Clinic",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},"100591408","phase-2-testing-whether-cemiplimab-regn2810-plus-cdx-1140-given-prior-to-surgery-are-better-than-cemiplimab-regn2810-alone-in-patients-with-stage-iii-iv-head-and-neck-cancer-100591408","NCT06980038","Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer","A Phase 2 Window of Opportunity Trial of Neoadjuvant Agonistic Anti-CD40 Antibody CDX-1140 and Cemiplimab (REGN2810) in AJCC Stage III-IV Head and Neck Cancer Patients Prior to Surgery","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed American Joint Committee on Cancer (AJCC) stage III-IV T0-4, N0-3b, M0 mucosal head and neck squamous cell carcinoma (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx, and nasal cavity) that is appropriate for surgical resection. Both previously untreated (primary) and recurrent (salvage) settings will be eligible. Tumors must be accessible to biopsy in clinic (patients with laryngeal, hypopharyngeal, nasal cavity and base of tongue tumors will have endoscopic biopsies)\n* For patients with oropharyngeal cancer, only p16-negative (non-human papillomavirus \\[HPV\\] related) patients will be eligible\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of cemiplimab (REGN2810) alone or in combination with CDX-1140 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin (Hb) ≥ 7 g\u002FdL (transfusion allowed to bring Hb to this level)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine ≤ 1.5 × institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* 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\n* 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 Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Women of childbearing potential and men should use effective contraception during treatment with cemiplimab (REGN2810) and for 4 months after the last dose. The reproductive and developmental toxicity of CDX-1140 has not been evaluated. Women of childbearing potential and their partners who receive CDX-1140 must therefore take adequate contraceptive measures\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Active or documented history of autoimmune disease within 2 years before screening\n* Prior or planned allogeneic hematopoietic stem cell transplantation (HSCT)\n* History of organ transplant that requires use of immunosuppressive medications\n* Current or prior use of immunosuppressive medication within 14 days prior to the start of study drug administration. Immunosuppressants may interfere with study drug efficacy\n* Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab (REGN2810). It is unclear how prior exposure to immunotherapy would impact future use of checkpoint inhibitors\n* Concurrent use of prednisone (10 mg or more)\n* Patients with new pulmonary infiltrates indicative of pneumonitis, history of (non-infectious) pneumonitis\u002Finterstitial lung disease, or current pneumonitis\u002Finterstitial lung disease, including grade 1 pneumonitis (i.e., asymptomatic, clinical or diagnostic observation only, intervention not indicated)\n* Another active malignancy for which the natural history or treatment has potential to interfere with the safety or efficacy assessment of the investigational regimen on this trial\n* Patients who have not recovered from AE due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents, such as concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1140 or cemiplimab (REGN2810)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed during treatment with cemiplimab (REGN2810) and for at least 4 months after the last dose. These risks may also apply to CDX-1140",{"count":293,"type":21},44,[24],"This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody 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 cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.",[81,297,298,299,300,301,27,28,29,302,30,31,153,154,303,155,207,159,160,304,164,165],"Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasal Cavity Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Recurrent Nasal Cavity Squamous Cell Carcinoma","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","2026-05-29",{"date":307,"type":36},"2026-06-01",{"date":309,"type":36},"2026-05-27",{"date":311,"type":21},"2027-11-24",{"name":42,"class":43},6,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":352},"100576722","phase-2-fortifi-hn01-a-study-of-ficerafusp-alfa-bca101-or-placebo-in-combination-with-pembrolizumab-in-first-line-pd-l1-pos-r-or-m-hnscc-100576722","NCT06788990","FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC","A Multicenter, Randomized, Double-blind, Phase 2\u002F3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","FORTIFI-HN01","Inclusion Criteria:\n\n* Age ≥18 years on the day the Informed Consent Form is signed.\n* Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.\n* No prior systemic therapy administered in the R or M setting; and completed systemic therapy \\>6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting.\n* Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.\n* PD-L1 CPS ≥1.\n* Measurable disease based on RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function, as defined in the protocol.\n\nExclusion Criteria:\n\n* Disease suitable for local therapy administered with curative intent.\n* Prior treatment with anti-TGFβ therapy.\n* Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).\n* Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.\n* Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.\n* Progressive disease \\\u003C6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.\n* Life expectancy less than 3 months.\n* Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.\n* Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.\n* Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.\n* Active autoimmune disease requiring systemic treatment in the past 2 years.\n* Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.\n* Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.\n* Known history of human immunodeficiency virus (HIV).\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening.\n\nOther Inclusion\u002FExclusion criteria may apply as defined in the protocol.",{"count":323,"type":21},650,[24,191],"Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).\n\nThis study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).",[116,27],[328,329,330,331,332,333,334,335,336,337,338,339,340,341,342],"Phase 2\u002F3","Ficerafusp alfa","BCA101","Recurrent Head and Neck Squamous Cell Carcinoma (R HNSCC)","Metastatic Head and Neck Squamous Cell Carcinoma (M HNSCC)","Pembrolizumab","EGFR","TGF-beta","HNSCC","PD-L1+","Head and Neck cancer","Oral Cavity","Oropharynx","Larynx","Hypopharynx",{"date":344,"type":36},"2026-06-02",{"date":346,"type":36},"2025-01-28",{"date":348,"type":21},"2029-07",{"name":350,"class":351},"Bicara Therapeutics","INDUSTRY",173,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":68},"100566967","remote-audiometry-to-monitor-for-treatment-related-hearing-loss-in-patients-with-hn-scc-receiving-cisplatin-andor-radiation-100566967","NCT06662058","Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and\u002For Radiation","Ototoxicity Monitoring and Remote Audiometry","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent\u002Fmetastatic disease\n* Subjects who will be treated with cisplatin chemotherapy and\u002For radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and\u002For parotid salivary gland\n* Life expectancy of more than 3 months, as determined by the investigator\n\nExclusion Criteria:\n\n* Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report\u002Fhistory or audiogram done before or after informed consent\n* Patients who are unable to participate in a hearing test (per the investigator's judgment)",{"count":361,"type":21},118,[363],"NA","This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation.",[366,367,368,81,297,298,369,116,194,195,370,196,197,371,372,300,301,373,374,27,28,29,375,30,31,150,271,204,205,206,376,207,377],"Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Cutaneous Squamous Cell Carcinoma of the Head and Neck","Head and Neck Carcinoma of Unknown Primary","Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck","Metastatic Nasopharyngeal Squamous Cell Carcinoma","Metastatic Paranasal Sinus Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Paranasal Sinus Squamous Cell Carcinoma","Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck","Recurrent Nasopharyngeal Squamous Cell Carcinoma","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","2026-04-20",{"date":380,"type":36},"2026-04-23",{"date":382,"type":36},"2025-03-12",{"date":384,"type":21},"2029-10-31",{"name":386,"class":67},"Emory University",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100521075","phase-3-a-study-of-ficlatuzumab-in-combination-with-cetuximab-in-participants-with-recurrent-or-metastatic-rm-hpv-negative-head-and-neck-squamous-cell-carcinoma-100521075","NCT06064877","A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R\u002FM) HPV Negative Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R\u002FM) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN)","FIERCE-HN","Inclusion Criteria:\n\n* Male or female and ≥ 18 years of age\n* Histologically and\u002For cytologically confirmed primary diagnosis of R\u002FM HNSCC\n* Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report\n* At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented\n* Participants must have failed prior therapy with an anti-PD-1\u002FPD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R\u002FM setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment\n* Patient's tumor must be considered inoperable and incurable\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks\n* For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization\n* For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 5 months after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly.\n* Ability to give written informed consent and comply with protocol requirements\n* Patients with feeding tubes are eligible for the study.\n* Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for c-Met analysis (if a tissue sample is not available, a fresh biopsy may be required prior to enrollment)\n\nExclusion Criteria:\n\n* Participants who have received \\> 2 prior lines of anticancer therapy or prior treatment with cetuximab\u002Falternative EGFR inhibitors for the treatment of R\u002FM HNSCC\n* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab\n* Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment.\n* Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization):\n\n  1. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors\n  2. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates\n  3. 4 weeks (28 days) for cell therapies\n  4. 2 weeks (14 days) for radiation therapy\n* Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] version 5.0) Grade 2 or greater from previous anticancer therapy (including radiation therapy), other than alopecia\n* Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)\n* Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant's involvement in the study or interfere with the interpretation of study results\n* History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)\n* Participants who are positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) with indication of acute or chronic hepatitis (as defined in protocol)\n* Radiographic evidence (historical or at screening) of interstitial lung disease or idiopathic pulmonary fibrosis\n* Female participants who are pregnant or breastfeeding\n\nA full list of inclusion and exclusion criteria can be found in the protocol.",{"count":396,"type":21},410,[191],"The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent\u002Fmetastatic (R\u002FM) HPV-negative Head and Neck Cancer.\n\nThe primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and\u002For overall survival.",[229,27],[401,402,403,404,405],"Recurrent","Metastatic","HPV-negative","Head and Neck","Squamous Cell Carcinoma","2026-04-06",{"date":408,"type":36},"2026-04-09",{"date":410,"type":36},"2024-01-11",{"date":412,"type":21},"2027-11",{"name":414,"class":351},"AVEO Pharmaceuticals, Inc.",112,{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":68},"100391315","phase-2-cetuximab-after-immunotherapy-for-the-treatment-of-head-and-neck-squamous-cell-cancer-100391315","NCT04375384","Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer","Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.\n* Measurable disease by scans- at least one measurable lesion.\n* Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy.\n* Patients must have a Performance Status of 0-2.\n* Patients must be greater than or equal to 18 years old.\n* Participant is willing and able to comply with the protocol for the duration of the study.\n* Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years.\n* Prior allergic reaction to Cetuximab.\n* History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab.\n* Patients receiving any other investigational agents.\n* Patient is on medications that need to be continued and that might interact with Cetuximab.\n* Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures.\n* Participant with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging.\n\nAny of the following conditions:\n\n* Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician\n* history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment\n* history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment\n* history of myocardial infarction, ventricular arrhythmia, stable\u002Funstable angina, -symptomatic congestive heart failure, coronary\u002Fperipheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment\n* history of arterial or venous thrombosis\u002Fthromboembolic event, including pulmonary embolism within 6 months of study enrollment\n* any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids.\n\nPregnancy, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.",{"count":424,"type":21},38,[24],"This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent\u002F metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.",[81,27,229],"2026-03-17",{"date":430,"type":36},"2026-03-18",{"date":432,"type":36},"2020-07-01",{"date":434,"type":21},"2027-12",{"name":436,"class":67},"Wake Forest University Health Sciences",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":68},"100508524","phase-1-evaluating-111in-panitumumab-for-nodal-staging-in-head-and-neck-cancer-100508524","NCT05901545","Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer","Inclusion Criteria:\n\n* Age ≥ 19 years.\n* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).\n* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.\n* Planned standard of care elective neck dissection for node-negative or node-positive disease.\n* Have acceptable hematologic status, kidney function, and liver function including the following clinical results:\n\n  * Hemoglobin ≥ 9 gm\u002FdL\n  * White blood cell count \\> 3000\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Serum creatinine ≤ 1.5 times upper reference range\n\nExclusion Criteria:\n\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.\n* History of infusion reactions to monoclonal antibody therapies\n* History of allergies to iodine\n* Pregnant or breastfeeding.\n* Magnesium or potassium lower than the normal institutional values.\n* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n* Severe renal disease or anuria.","19 Years",{"count":445,"type":21},30,[55],"This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography\u002Fcomputed tomography (SPECT\u002FCT). SPECT\u002FCT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT\u002FCT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.",[81,27],"2026-03-03",{"date":451,"type":36},"2026-03-05",{"date":453,"type":36},"2023-08-22",{"date":212,"type":21},{"name":456,"class":67},"Vanderbilt-Ingram Cancer Center",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":471,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":94},"100582832","phase-1-tmv-vaccine-therapy-alone-and-with-pembrolizumab-for-the-treatment-of-recurrent-andor-metastatic-head-and-neck-squamous-cell-cancer-100582832","NCT06868433","TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and\u002For Metastatic Head and Neck Squamous Cell Cancer","Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Must be at least ≥ 18 years of age\n* Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal carcinoma and cancer of unknown primary (squamous cell carcinoma only) are all allowed. They will be allowed to have up to 3 different regimens after diagnosed of recurrent or metastatic HNSCC\n* Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done\n* The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form \\[ICF\\] must be signed)\n* Recurrent and\u002For metastatic HNSCC that has failed standard chemotherapy and immunotherapy. Eligible subjects must have progressed on ≥ 2 lines of standard of care prior to starting trial therapy. For patients who have relapsed within 6 months of systemic therapy given with curative intent, that therapy will count as a line of metastatic therapy. Eligible subjects will have no restriction on prior lines of therapy in the metastatic\u002Fadvanced disease setting\n* The tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Must have enough tissue collected after salvage surgery to make at least 3 doses of vaccine (minimum weight of the resectable tumor tissue is ≥ .5 grams) and adequate cellularity (\\> 40% cellularity) assessed by the head and neck pathologists\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* Absolute neutrophil count ≥ 1,500 cells\u002FuL\n* Platelets ≥ 100,000\u002FuL\n* Hemoglobin ≥ 9.0g\u002FdL (may receive packed red blood cell \\[prbc\\] transfusion)\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Albumin ≥ 3.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN\n* Calculated creatinine clearance of ≥ 50 mL\u002Fmin\n* International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving low molecular weight (LMW) heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \\\u003C 1.1U\u002FmL are allowed on the trial\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Ability to understand and willingness to sign written informed consent documents\n* Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion\n* Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion\n* Female subjects of childbearing age must have a negative serum pregnancy test at study entry\n* Patients who have received prior pembrolizumab are eligible\n\nExclusion Criteria:\n\n* Salivary tumors and non-squamous cell histology in head and neck cancer\n* Not enough tissue collected after surgery for a planned 3 doses (weight of the resectable tumor tissue is less than 1.0 gram)\n* Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)\n* Prior organ allograft or allogeneic bone marrow transplantation\n* Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma\u002Fatopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Women who are pregnant or lactating, and child-bearing potential women without adequate contraception\n* Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Other medications, or severe acute\u002Fchronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study\n* Clinical evidence of bleeding diathesis or coagulopathy\n* Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \\> 5 years. Patients with prior in situ carcinomas are eligible provided there was complete removal\n* Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment\n* Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Non-oncology vaccines within 28 days prior to planned treatment",{"count":53,"type":21},[55],"This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and\u002For effective in treating patients with recurrent and\u002For metastatic head and neck squamous cell cancer.",[366,116,194,195,370,196,197,468,27,28,29,375,30,31,469,470,271,204,205,206,376,207,377],"Metastatic Sinonasal Squamous Cell Carcinoma","Recurrent Sinonasal Squamous Cell Carcinoma","Squamous Cell Carcinoma of Unknown Primary",[472],"Recurrent or metastatic head and neck cancer whose tumor should have banked at the time of surgery.","2026-03-02",{"date":475,"type":36},"2026-03-04",{"date":477,"type":36},"2025-05-08",{"date":134,"type":21},{"name":386,"class":67},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":501},"100594978","phase-3-re-radiochemotherapy-and-pembrolizumab-vs-immunochemotherapy-for-locoregionally-recurrent-pd-l1-positive-cps1-hnscc-100594978","NCT07026474","Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC","Randomized Phase III Trial of Sequential Re-Radiochemotherapy and Pembrolizumab Versus Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive HNSCC (CPS≥1)","RePaIr-HN","Inclusion Criteria:\n\n* Written informed consent obtained from the subject prior to performing any protocol-related procedures.\n* Age ≥ 18 years at time of study entry.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Locoregionally recurrent or second primary HNSCC.\n* Histological confirmation of HNSCC.\n* Tumor is surgically not resectable or surgical resection bears great potential for relevant functional morbidity or patient refuses surgery.\n* No distant metastases (cM0).\n* PD-L1 combined positive score (CPS) ≥1 according to local pathological PD-L1 assessment. A validated test must be used in an accredited laboratory.\n* Prior radio(chemo)therapy of the neck (time interval ≥ 6 months).\n* Adequate normal organ and marrow function as defined: Haemoglobin ≥ 9.0 g\u002FdL; Leukocytes (WBC) ≥ 3,000 per mm3or Neutrophils ≥ 1,500 per mm3; Platelet count \\> 100,000 per mm3.\n* Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology).\n* AST (SGOT) \u002F ALT (SGPT) ≤ 2.5 x institutional ULN.\n* Creatinine Clearance ≥ 40ml\u002Fmin (calculated from serum creatinine using the Cockcroft-Gault formula).\n* Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of RT and\u002For the first dose of pembrolizumab. A highly sensitive pregnancy test must be used.\n* Female subjects of childbearing potential must be willing to use a highly effective contraceptive measure (see also Section 7.1.9 Contraception and pregnancy testing during the trial). Highly effective contraception is required for the course of the trial through 120 days after the last dose of trial therapy.\n* Generative male subjects must agree to use a highly effective method of contraception (see also Section 7.1.9 Contraception and pregnancy testing during the trial), starting with the first dose of trial therapy through 120 days after the last dose of trial therapy.\n* Subject is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations including.\n\nExclusion Criteria:\n\n* Prior radio(chemo)therapy of the neck less than 6 months ago.\n* Distant metastases (cM1).\n* Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of trial treatment. The following are exceptions to this criterion:\n\n  1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* Prior chemotherapy or targeted small molecule therapy within 2 weeks or anti-cancer monoclonal antibody (mAb) within 4 weeks prior to trial day 1 or who has not recovered from AEs due to a previously administered agent. (Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the trial.)\n* History or concurrent other malignancy. Exceptions include patients, who have been disease free for at least 3 years. Further exceptions are completely resected basal cell carcinoma or squamous cell carcinoma of the skin or successfully treated in situ carcinoma.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Has an active or chronic infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to randomization or first dose of study drugs.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* 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 trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Infection with human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Live vaccine within 30 days of planned start of trial therapy.\n* Performance status of \\>2 on the ECOG Performance Scale.\n* Prior treatment with a PD-1\u002FPD-L1 antibody in primary treatment of locally advanced HNSCC less than 6 months ago.",{"count":489,"type":21},214,[191],"Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive (CPS≥1) HNSCC.",[27],"2026-02-27",{"date":473,"type":36},{"date":496,"type":36},"2025-10-30",{"date":498,"type":21},"2032-12-31",{"name":500,"class":67},"Universität des Saarlandes",18,{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":508,"maxAge":4,"enrollmentInfo":509,"targetDuration":510,"studyType":511,"phases":4,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":68},"100568246","establishment-of-a-microfluidic-based-liquid-biopsy-platform-for-recurrentmetastatic-head-and-neck-cancers-prognostication-using-nk-cell-ifn--expression-and-ctm-correlation-with-ds-saca-chip-100568246","NCT06678724","Establishment of a Microfluidic Based Liquid Biopsy Platform for Recurrent\u002FMetastatic Head and Neck Cancers Prognostication Using NK Cell IFN-γ Expression and CTM Correlation With DS-SACA Chip","Inclusion Criteria: must fulfill with all the items below\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.\n* \\>=20 years old.\n* had pathologically confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx that was recurrent or metastatic and not curable by local therapy.\n* had at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Medical records during treatment are available.\n\nExclusion Criteria:\n\n* Medical records during treatment unavailable\n* Could not cooperate with blood sampling\n* Without informed consent","20 Years",{"count":445,"type":21},"2 Years","OBSERVATIONAL","The goal of this observational study is to learn about the prognostic value of circulation tumor emboli (CTM) in recurrent\u002Fmetastatic head and neck cancer patients and also the changes of tumor microenvironment by different treatment modalities and drugs. The main questions it aims to answer are:\n\n1. Investigators plan to correlate circulating tumor cells (CTC), circulating tumor emboli (CTM), and the composition of NK cells in CTM with clinical outcomes and establish their association with patient prognosis.\n2. Investigators plan to understand the composition of NK cells and the immune cell components within CTM, and correlate these findings with treatment efficacy.\n\nPatients with recurrent\u002Fmetastatic head and neck cancer will be included after informed consent and investigators will collect blood samples for analysis from them under the treatment provided by their primary care physicians.",[514,515,27],"Head and Neck Cancers- Squamous Cell","Head and Neck Cancer Metastatic",[517,518,519,520,521,522,523,524,525],"head and neck cancer","circulating tumor cell","CTC","circulating tumor emboli","CTM","NK cell","nature killer cell","prognosis","INF-gamma","2026-02-22",{"date":528,"type":36},"2026-02-24",{"date":530,"type":36},"2025-01-01",{"date":532,"type":21},"2027-12-31",{"name":534,"class":67},"National Taiwan University Hospital",{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":94},"100565019","phase-2-lovastatin-and-pembrolizumab-for-the-treatment-of-patients-with-recurrent-or-metastatic-head-and-neck-cancer-lapp-trial-100565019","NCT06636734","Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial","A Phase II Trial Of Lovastatin And Pembrolizumab In Patients With RM HNSCC (LAPP)","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can be included if human papillomavirus (HPV)-positive\n* PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)\n* Patients must not be under consideration for salvage surgery\n* Measurable disease by RECIST 1.1 criteria\n* Life expectancy of more than 3 months, as determined by the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and\u002For stable on supportive therapy\n* For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of lovastatin\u002Fpembrolizumab administration\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 without colony stimulating factor support\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002FdL\n* Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL\n* Serum albumin ≥ 2.8 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN\n* Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)\n\nExclusion Criteria:\n\n* Patients already taking a statin drug\n* Liver dysfunction precluding the use of statins\n* Radiation to the head and neck or other sites within 4 weeks prior to enrollment\n* Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment\n* Prior treatment with immune checkpoint blocking therapy\n* Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)\n* Pregnancy, lactation, or plan to become pregnant\n* Inability to swallow lovastatin tablets\n* Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab",{"count":77,"type":21},[24],"This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.",[366,546,116,194,195,370,196,197,371,27,28,29,375,30,31,150,204,205,206,376,207,377],"Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary","2026-02-08",{"date":549,"type":36},"2026-02-11",{"date":551,"type":36},"2024-12-09",{"date":134,"type":21},{"name":386,"class":67},{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":564,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":590},"100569820","phase-3-a-study-of-asp-1929-photoimmunotherapy-in-combination-with-pembrolizumab-in-first-line-treatment-of-locoregional-recurrent-squamous-cell-carcinoma-of-the-head-and-neck-with-no-distant-metastases-100569820","NCT06699212","A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases","A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases","ECLIPSE","Inclusion Criteria:\n\n* Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \\[AJCC\\], other than nasopharynx or cuSCC).\n* Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy.\n* No known history of any distant metastatic disease (M1 by AJCC eighth edition).\n* Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator.\n* Anti-PD-1 and anti-PD-L1-treatment naïve.\n* Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test\n* Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening\n* Adequate hematologic, renal, and hepatic organ function\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Diagnosed and\u002For treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.\n* History of significant (Grade ≥ 3) cetuximab infusion reactions\n* Prior allogeneic tissue\u002Fsolid organ transplant\n* Known or active central nervous system metastases and\u002For carcinomatous meningitis\n* Life expectancy of less than 3 months\n* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* Evidence of interstitial lung disease or current active, noninfectious pneumonitis\n* Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention\n* Known or active bacterial, viral, or fungal infection including tuberculosis, Hepatitis B (e.g., HBV DNA is detected), or Hepatitis C (e.g., RNA \\[qualitative\\] is detected)\n* Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS)-related illness\n* Prior or ongoing Grade ≥ 3 tumor hemorrhage within 12 weeks of randomization\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent\n* Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent\n* Prior receipt of ASP-1929 at any time\n* Receiving chronic systemic steroid therapy (in doses exceeding 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to randomization\n* Received a live vaccine within 4 weeks of randomization; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed\n* Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment exposing the patient to significant light (e.g., eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment\n* Major surgery or significant traumatic injury within 4 weeks before randomization, or anticipation of the need for major surgery during the course of study treatment",{"count":563,"type":21},412,[191],"The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab.\n\nResearchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm).\n\nThe overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion\u002Fexclusion criteria over the control arm.",[27],[336,568,81,300,569,570,571,572,573,574,575,576,577,578,579,580],"Squamous Cell Carcinoma of Head and Neck","Squamous Cell Carcinoma of the Head and Neck","immunotherapy","medical device","laser phototherapy","Epidermal Growth Factor Receptor","PD-1 Inhibitor","Immune Checkpoint Inhibitor","Alluminox","Rakuten Medical","ASP-1929","photoimmunotherapy","head and neck","2025-10-13",{"date":583,"type":36},"2025-10-15",{"date":585,"type":36},"2024-12-24",{"date":587,"type":21},"2028-09",{"name":589,"class":351},"Rakuten Medical, Inc.",22,{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":16,"minAge":443,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":608,"locationsCount":68},"100511932","phase-1-evaluating-the-use-of-dual-imaging-techniques-for-detection-of-disease-in-patients-with-head-and-neck-cancer-100511932","NCT05945875","Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer","Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer","Inclusion Criteria:\n\n* Age \\>= 19 years\n* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck\n* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed\n* Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging\n* Hemoglobin \\>= 9 gm\u002FdL\n* White blood cell count \\> 3000\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Serum creatinine =\\\u003C 1.5 times upper reference range\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)\n* History of infusion reactions to monoclonal antibody therapies\n* History of allergies to iodine\n* Pregnant or breastfeeding\n* Magnesium or potassium lower than the normal institutional values\n* Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Severe renal disease or anuria\n* Thyroid stimulating hormone (TSH) \\> 13 micro international units\u002FmL",{"count":53,"type":21},[55],"This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)\u002Fcomputed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT\u002FCT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT\u002FCT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.",[81,27],"2025-09-29",{"date":604,"type":36},"2025-10-03",{"date":606,"type":36},"2023-10-03",{"date":134,"type":21},{"name":456,"class":67}]