[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kaposi-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kaposi-sarcoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,51,83,107,128,160,185,210,273,355,380,402,426,447,473,501],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100585118","precision-imaging-to-evaluate-kaposi-sarcoma-100585118",false,"NCT06898203","Precision Imaging to Evaluate Kaposi Sarcoma","Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)","PRIME-KS","Inclusion Criteria - Aim 2 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* At least 3 skin lesions\n* Capable of informed consent\n* On treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 2 (Patients):\n\n* Patients not initiating Kaposi Sarcoma treatment\n* Very ill patients requiring hospitalization\n\nInclusion Criteria - Aim 3 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* Capable of informed consent\n* Initiating treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 3 (Patients):\n\n* Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2\n* Prior or ongoing Kaposi Sarcoma treatment",true,"ALL","18 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","AIMS 2 \\& 3:\n\nIn this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.",[28],"Kaposi Sarcoma",[30,28,31,32,33,34,35,36,37],"Global Oncology","Affordable Cancer Technologies","Cancer in People with HIV","Human Centered Design","Discrete Choice Experiment","Medical devices","Low-cost design","Global health","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":42},"2026-04-10",{"date":46,"type":22},"2029-11-30",{"name":48,"class":49},"Washington University School of Medicine","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100431771","phase-1-pomalidomide-and-nivolumab-in-people-with-virus-associated-malignancies-with-or-without-hiv-100431771","NCT04902443","Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV","A Phase I Study of Pomalidomide and Nivolumab in Patients With Virus-Associated Malignancies With or Without HIV","* INCLUSION CRITERIA:\n* Histologically or cytologically proven selected virus-associated tumors that are systemic, metastatic or locally advanced and not amenable to curative treatment options or are relapsed\u002Frefractory to first-line therapy as appropriate for each tumor type as outlined below. Also, participants with eligible solid tumors, who after evaluation by an expert in the area are deemed to be potentially curable after extensive surgery, but refuse such surgical procedure due to associated disfigurement and\u002For morbidity, may be eligible for the study with the necessary informed consent. Pathology confirmation by NCI Laboratory of Pathology is needed for eligibility.\n\nThe following tumor types listed below are eligible, and require assessing of virus infection of the tumor cells with EBV EBER by in situ hybridization (ISH), KSHV LANA , p16, and Merkel cell polyomavirus large T antigen by immunohistochemistry (IHC) to document the respective viral infection (EBV, KSHV, HPV, MCPvY); or detection of serum HBV surface antigen, anti-HBV core antibody, elevated HBV DNA viral load, positive HVC antibody or elevated HCV RNA viral load. The tumor types studied in the phase 1 trial will be as below. For tumors where \\>95% are known to be virus-associated, such as cervical cancer, confirmation of virus status is not required.\n\n--EBV-positive Hodgkin lymphoma meeting the following criteria:\n\n* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and\n* Unresponsive or progressive disease after treatment with brentuximab vedotin or may be brentuximab vedotin na(SqrRoot) ve but is ineligible or unable to receive brentuximab vedotin; and\n* Unresponsive or progressive disease after checkpoint inhibitor therapy;\n\nand\n\n* Unresponsive or progressive disease after or is ineligible for autologous stem cell transplant (auto-SCT)\n\n  --EBV-positive aggressive non-Hodgkin lymphomas meeting the following criteria:\n* Relapsed\u002Frefractory disease after standard first-line chemotherapy; and\n* Relapsed disease after autologous stem cell transplant if indicated for histology (i.e diffuse large B-cell lymphoma relapsed more than one year after first line treatment) or autologous stem cell transplant is not feasible; and\n* Relapsed after CAR-T cell therapy for HIV-negative participants only if indicated for histology (i.e., diffuse large B-cell lymphoma) or CAR-T cell therapy is not feasible\n\n  * EBV-positive nasopharyngeal cancer unresponsive or progressive disease on or after platinum-containing chemotherapy and\u002For radiotherapy\n  * EBV-positive gastric cancer that is unresponsive or progressive disease on or after first-line chemotherapy\n  * EBV-positive leiomyosarcomas that is unresponsive or progressive disease on or after 2 systemic regimens (CCRT\u002Fplatinum-taxane)\n  * Kaposi sarcoma impairing physical wellbeing (for example, tumor edema, pain, skin ulceration or breakdown, oral disease impairing function), no active KSHV-associated multicentric Castleman disease in past 12 months, and one or more of the following:\n* Inadequate tumor response after 6 or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or\n* Progressive disease while receiving liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or\n* Intolerant of liposomal doxorubicin and paclitaxel\n\n  * Primary effusion lymphoma unresponsive or progressive disease on or after first-line combination chemotherapy\n  * HPV-positive head and neck cancer that is unresponsive or progressive on or after first-line combination chemotherapy +\u002F- radiotherapy\n  * HPV-positive cervical cancer that is unresponsive or progressive on at least one systemic regimen for recurrent (does not include initial CCRT) or metastatic disease. Tumor HPV testing will not be a requirement for study eligibility for cervical cancer.\n  * HPV-positive anal cancer that is unresponsive or progressive on or after first-line combination chemotherapy +\u002F- radiotherapy\n  * HPV-positive vaginal cancer that is unresponsive or progressive on or after first-line chemotherapy\n  * HPV-positive penile cancer that is unresponsive or progressive on or after surgery and first-line chemotherapy\n  * HPV-positive vulvar cancer that is unresponsive or progressive on or after first- line combination chemotherapy\n  * MCPyV-positive Merkel cell carcinomas that is relapsed or refractory after prior checkpoint inhibitor therapy\n  * HBV- or HCV-associated hepatocellular carcinoma that is not amenable to local therapy or liver transplant and has progressed on first-line therapy with sorafenib or levatinib or atezolizumab+bevacizumab\n\n    * For solid tumors, participants 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    * For hematologic malignancies, participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (lymph nodes must measure \\>=15 mm in the short axis and extranodal lesions must measure \\>=10 mm in the short axis with CT scan. For primary effusion lymphoma, body cavity effusions may be followed as measurable disease by CT scan.\n    * For KS, participants must have measurable disease, defined as at least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.\n    * Prior immunomodulatory therapy and checkpoint inhibitor therapy is allowed if previously tolerated without severe toxicities. Participants may not have received chemotherapy, radiotherapy, monoclonal antibody therapy, or targeted therapy within 2 weeks.\n    * Age \\>=18 years. Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with nivolumab in participants \\\u003C18 years of age, children are excluded from this study.\n    * ECOG performance status \\\u003C=2 (Karnofsky \\>=60%).\n    * Participants must have adequate organ and marrow function as defined below:\n  * leukocytes no lower limit\n  * absolute neutrophil count \\>=1,000\u002FmcL\n  * platelets \\>=75,000\u002FmcL\n\n    * total bilirubin \\\u003C= institutional upper limit of normal (ULN), except for participants with Gilbert disease or in whom the elevated bilirubinemia is due to ART (must be grade \\\u003C= 2)\n    * AST(SGOT)\u002FALT(SGPT) \\\u003C=3x institutional ULN\n  * glomerular filtration rate (GFR) \\>=30 mL\u002Fmin\u002F1.73 m\\^2\n\n    -Participants with any HIV status are eligible; for HIV-positive participants:\n  * Must be on antiretroviral therapy (ART) \\>4 weeks and with evidence of viral suppression defined as HIV viral load \\\u003C 400 copies\u002FmL\n  * Must have no major (e.g. AIDS-defining) opportunistic infections within the last 6 months except for the following which will be allowed:\n  * Esophageal candidiasis treated within last 6 months or currently improving with antifungal treatment\n  * Oral and\u002For genital HSV treated within last 6 months or currently improving with antiviral treatment\n\n    * Mycobacterium avium infection in last 6 months or that has been treated for at least 1 month\n    * For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy.\n    * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n    * Able to take aspirin 81mg daily or a substitute thromboprophylaxis such as low molecular weight heparin at a prophylactic dose.\n    * Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n    * Participants 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    * Participants 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, such as carcinoma in situ or low-grade prostate carcinoma.\n    * Participants may not have cardiac or pulmonary abnormalities severe enough that they would pose a danger to receive treatment. To mitigate risks for cardiac AEs, screening EKG, echocardiogram, CPK, and troponin will be required and significant abnormalities as determined by the PI will need to be evaluated by Cardiology prior to enrollment. Participants with pulmonary symptoms will be required to undergo pulmonary function testing and Pulmonary evaluation at the discretion of the PI prior to enrollment.\n    * Current or history of systemic autoimmune disease requiring systemic immunosuppressive therapy will not be allowed. Note: the following will not be exclusionary: 1) the presence of laboratory evidence of autoimmune disease (e.g. positive antinuclear antibody titer or lupus anticoagulant) without associated symptoms; 2) clinical evidence of vitiligo or other forms of depigmenting illness; 3) mild\n\nautoimmunity not impacting the function of major organs (e.g. controlled Hashimoto thyroiditis, limited psoriasis)\n\n* Persons of childbearing potential (PCBP), defined as a woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months, i.e., has had menses at any time in the preceding 24 consecutive months) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from receptive vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. PCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during penetrative vaginal intercourse with a PCBP even if they have had a vasectomy. All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants who have had anticancer treatment within the last 2 weeks, unless the cancer treatment is for a 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, such as local treatment for carcinoma in situ or hormonal therapy for prostate or breast carcinoma.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the following exceptions:\n\n  * Elevated triglyceride attributed to ART and\u002For HIV (must be \\\u003C= Grade 2)\n  * Laboratory or clinical abnormalities that are assessed as more likely to be from the underlying tumors, HIV disease, or other non-treatment causes will not be considered an exclusion criterion.\n  * Alopecia, neuropathy and ototoxicity (i.e., AEs that are not expected to improve within the washout period)\n  * Participants who are receiving any other investigational agents.\n* Participants will be excluded if they are on systemic steroid therapy that cannot be discontinued, with the exception of the use of prednisone or equivalent \\\u003C0.125mg\u002Fkg\u002Fday as replacement therapy. Inhaled or topical steroids are permitted.\n* History of allergic reactions attributed to pomalidomide and\u002For nivolumab or compounds of similar chemical or biologic composition to pomalidomide and\u002For nivolumab.\n* Participants who have received prior allogeneic stem cell or organ transplant.\n* Participants with severe uncontrolled intercurrent illness.\n* Cirrhosis with Child-Pugh score of B or C\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and nursing persons are excluded from this study because pomalidomide is a thalidomide analog. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. These potential risks may also apply to nivolumab based on its mechanism of action and data from animal studies. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death.","99 Years",{"count":60,"type":22},58,[62],"PHASE1","Background:\n\nLess toxic and more effective treatments are needed for cancers caused by viruses. These cancers include Hodgkin and non-Hodgkin lymphoma, hepatocellular carcinoma, head and neck cancer, nasopharyngeal carcinoma, gastric cancer, anal cancer, cervical cancer, vaginal cancer, vulvar cancer, penile cancer, Merkel cell carcinoma, Kaposi sarcoma, and leiomyosarcoma. Researchers want to see if a combination of drugs can help.\n\nObjective:\n\nTo find a safe dose of pomalidomide plus nivolumab in people with cancers caused by viruses.\n\nEligibility:\n\nAdults ages 18 or older who have cancers caused by Epstein Barr virus (EBV), human herpes virus 8\u002FKaposi sarcoma herpesvirus (HHV8\u002FKSHV), human papilloma virus (HPV), hepatitis B or C virus (HBV\u002FHCV), and Merkel cell polyomavirus (MCPyV) that have not responded to previous treatments or have relapsed, or in adults who do not want to have surgery because of disfigurement or other risks. Adults who have HIV with any CD4 T cell count are eligible.\n\nDesign:\n\nParticipants will be screened with blood and urine tests, scans, and heart tests. They will have a physical exam. Their ability to perform normal daily activities will be assessed. They may have a tumor biopsy.\n\nTreatment will be given in 28-day cycles. Participants will take pomalidomide as a tablet by mouth for 21 days of each cycle, for up to 24 cycles. They will get nivolumab by intravenous infusion once each cycle. They will take an aspirin each day until 30 days after their last dose of the study drugs.\n\nParticipants will keep a pill diary. They will bring it to their study visit at the end of each cycle. At these visits, some screening tests will be repeated. Participants with Kaposi sarcoma will have pictures taken of their lesions.\n\nParticipants will give blood and saliva samples for research. They may have optional anal and\u002For cervical swabs. They may have optional biopsies.\n\nParticipants will have a follow-up visit 30 days after they stop taking the study drugs, then every month for 100 days. Some screening tests will be repeated. Then they may by contacted by phone every 3 months for 9 months, and then every 6 months thereafter.",[65,28,66],"Viral Associated Malignancies","EBV\u002FKSHV-associated Lymphomas",[68,69,70,71],"AIDS","Small Molecule Inhibitor","Immune Therapy","PD-L1","2026-06-04",{"date":74,"type":42},"2026-06-05",{"date":76,"type":42},"2021-12-10",{"date":78,"type":22},"2027-12-01",{"name":80,"class":81},"National Cancer Institute (NCI)","NIH",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":82},"100544917","natural-history-study-of-kaposi-sarcoma-100544917","NCT06375122","Natural History Study of Kaposi Sarcoma","* INCLUSION CRITERIA:\n\nParticipants must have histological KS confirmed by the Laboratory of Pathology (LP), NCI.\n\n* KS as assessed by cutaneous or oral KS lesions or other assessable KS disease.\n* Age \\>=18 years.\n* ECOG performance status \\\u003C=4.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL).\n* Participants with serious and\u002For uncontrolled severe intercurrent illness, such as opportunistic infections, that in the judgement of the investigator would preclude participation in the study.","120 Years",{"count":91,"type":22},150,"OBSERVATIONAL","Background:\n\nKaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs.\n\nObjective:\n\nTo learn more about the natural history of KS.\n\nEligibility:\n\nPeople aged 18 years and older with KS.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed.\n\nParticipants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include:\n\nEye exam.\n\nUltrasound exam of the heart (electrocardiogram).\n\nCollection of saliva and urine samples.\n\nBiopsies of the skin or lymph nodes.\n\nSwabs of the anus and cervix.\n\nPhotographs of skin lesions.\n\nRemoval of fluid samples from the space around the lungs, intestine, or heart.\n\nThe evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years.\n\nParticipants will follow their standard treatment for KS during the study.",[28,95],"HIV",[28,97,98],"Samples and data collection","Longitudinal clinical evaluations","2026-05-29",{"date":101,"type":42},"2026-06-01",{"date":103,"type":42},"2024-05-15",{"date":105,"type":22},"2036-12-31",{"name":80,"class":81},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":82},"100385777","phase-1-pds01adc-monotherapy-and-in-combination-with-m7824-in-advanced-kaposi-sarcoma-100385777","NCT04303117","PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma","Phase I\u002FII Study of PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma","* INCLUSION CRITERIA:\n* Individuals with biopsy proven (confirmed in the Laboratory of Pathology \\[LP\\], CCR) Kaposi sarcoma (KS)\n* KS requiring systemic therapy, with or without history of prior KS therapy:\n\n  * T1 KS or T0 KS sufficiently widespread that systemic therapy is advisable, or KS affecting quality-of-life due to local symptoms or psychological distress\n\nOR,\n\n* KS with an inadequate response to liposomal doxorubicin, paclitaxel, other systemic chemotherapy (either progressive disease or stable disease after 3 or more cycles) or immunotherapy (progressive disease)\n\n  * A wash-out period off treatment of 2 weeks from last chemotherapy and 4 weeks from last immunotherapy, other systemic treatment with a biologic agent, or monoclonal antibody therapy will be required in individuals with prior KS therapy.\n  * Resolution of toxicity from prior therapy to \\\u003C= Grade 1.\n  * At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.\n  * Measurable disease by the criteria proposed by the AIDS Clinical Trials Group (ACTG) Oncology Committee for KS\n  * HIV positive or negative.\n  * ART for HIV+ individuals for 8 or more weeks prior to entry with an HIV viral load of \\\u003C400 copies\u002Fml at screening and CD4+ T cell count of \\>= 50 cells\u002Fmicroliter as this may be expected if individuals have received several courses of chemotherapy.\n  * Age \\>=18 years.\n  * ECOG performance status \\\u003C=2 (Karnofsky \\>=60%).\n  * Adequate organ and marrow function as defined below:\n* Absolute neutrophil count \\>=1,000\u002FmcL\n* Platelets \\>=100,000\u002FmcL\n* Total bilirubin within normal institutional limits; OR \\\u003C3x institutional upper limit of normal (ULN) for Gilbert s syndrome or HIV protease inhibitors; OR \\\u003C5x ULN and direct bilirubin \\\u003C 0.7mg\u002FdL for individuals on atazanavir-containing HIV regimen\n* AST\u002FALT \\\u003C=1.5 X institutional ULN\n* Hemoglobin \\>= 9g\u002FdL\n* Creatinine within normal institutional limits OR creatinine clearance \\>30 mL\u002Fmin\u002F1.73m\\^2 as estimated by either Cockroft-Gault of 24- hour urine collection if creatinine levels above institutional normal\n\n  * Normal international normalized ratio (INR), prothrombin time (PT) \\\u003C= 1.5 x ULN, and activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x ULN (required only if participants will receive M7824)\n  * The effects of PDS01ADC and M7824 on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during treatment and for at least 4 months after the last dose of treatment and agree to inform the treating physician immediately if they become pregnant. Also, there is unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824 and\u002For PDS01ADC, therefore WOCBP must agree to discontinue nursing if treated with these agents.\n  * Ability of individual to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Receiving any other investigational agents.\n* Pregnant individuals are excluded from this study as the effects of PDS01ADC and M7824 have potential teratogenic or abortifacient effects.\n* Severe KS (such as symptomatic pulmonary KS) that could be life threatening if it progressed over 2-4 weeks\n* Actively bleeding sites caused by visceral KS.\n* Unwilling to accept blood products as medically indicated\n* Actively bleeding and\u002For requiring transfusions in the 2 weeks preceding study entry.\n* History of bleeding, diathesis, or recent major bleeding events within a period of 4 weeks considered by the investigator as high risk for investigational drug treatment.\n* Any active or recent history (symptomatic in the last 3 months) of a known or suspected autoimmune disease (with the exception of diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment) or recent history of a syndrome that required systemic corticosteroids (10mg daily prednisone or equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroids doses up to 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Uncontrolled opportunistic infections\n* Active multicentric Castleman disease\n* Individuals with primary effusion lymphoma\n* History of malignant tumors other than KS, unless:\n\n  * In complete remission for \\>= 3 years from the time complete remission was first documented or\n  * Resected basal cell or squamous cell carcinoma of the skin or\n  * In situ cervical or anal dysplasia\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC and\u002For M7824 investigational agents used in study.\n* Active tuberculosis (TB):\n\n  * Individuals who are undergoing first month of therapy (RIPE or equivalent) for active TB or\n  * Individuals with TB immune reconstitution syndrome (IRIS) requiring corticosteroids\n* Received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.\n* Uncontrolled substantial intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, that would limit compliance with study requirements.\n* Medical or psychiatric illness or social situation that would, in the opinion of the investigator, preclude participation in the study or the ability of individuals to provide informed consent for themselves.\n* Uncontrolled HBV infection, defined as plasma HBV DNA detectable by PCR\n\nNote: the following will NOT be exclusionary:\n\n* A positive hepatitis B serology indicative of previous immunization (i.e. HbsAb positive and HbcAb negative), or a fully resolved acute HBV infection\n* Chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines.\n\n  * Uncontrolled HCV infection, defined as plasma HCV DNA detectable by PCR\n\nNote: the following will NOT be exclusionary:\n\n* Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection\n* Successfully treated for HCV as long as therapy for HCV has been completed.\n\n  -Individuals will be excluded from the combination therapy arm if:\n* they have discontinued prior PD1\u002FL1 blocking agent due to immune mediated adverse event(s) OR\n* they have active non-infectious pneumonitis or a history of steroid requiring non-infectious pneumonitis.",{"count":115,"type":22},80,[62,117],"PHASE2","Background:\n\nKaposi sarcoma (KS) tumors grow on the skin, lymph nodes, lungs, bone, and gastrointestinal tract. KS often affects people with immune deficiencies, such as among people living with HIV or those with prior history of transplant. Researchers want to see if 2 non-chemotherapy drugs can help people with KS. PDS01ADC triggers the immune system to fight tumors. M7824 blocks the pathways that cancer cells use to stop the immune system from fighting tumors.\n\nObjective:\n\nTo learn if giving PDS01ADC alone or with M7824 could help the immune system fight KS tumors.\n\nEligibility:\n\nPeople 18 and older with KS that has been treated with chemotherapy or immunotherapy\n\nDesign:\n\nParticipants will be screened with some or all of the following:\n\nmedical history\n\nphysical exam\n\nchest X-ray\n\ncomputed tomography scan\n\nblood and urine tests\n\nelectrocardiogram and echocardiogram\n\nskin KS lesion biopsy\n\nlung exam\n\ngastrointestinal exam\n\nAll participants will get PDS01ADC every 4 weeks for up to 96 weeks (or 24cycles). It is injected under the skin.\n\nSome participants will also get M7824 every 2 weeks for up to 96 weeks (or 24cycles). It is given through a plastic tube that is put in an arm vein.\n\nParticipants will complete questionnaires about how KS affects their quality of life. Their KS lesions will be measured and photographed. They will repeat some of the screening tests. They will give saliva samples or additional tissue samples. They will have a lung function test. Their ability to perform their normal activities will be assessed. The treatment duration is up to 96 weeks (or 24cycles) with an option to take PDS01ADC and\u002For M7824 until the KS tumors are not responding, or you develop unacceptable side effects.\n\nParticipants will have follow-up visits 7 and 30 days after treatment ends, then every 3 to 6 months for the next 18 months, then once a year for 3 years.",[28],[70,68,95,121],"Immunocytokine",{"date":101,"type":42},{"date":124,"type":42},"2020-07-13",{"date":126,"type":22},"2028-12-01",{"name":80,"class":81},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"100490236","collecting-blood-and-tissue-sample-donations-for-research-for-hivaids-related-cancers-100490236","NCT05663502","Collecting Blood and Tissue Sample Donations for Research for HIV\u002FAIDS-Related Cancers","Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as:\n\n  * classic Kaposi sarcoma\n  * transplant-associated Kaposi sarcoma,\n  * anal cancer,\n  * multicentric Castleman's disease,\n  * Epstein Barr Virus (EBV) -positive lymphoma\n  * plasmablastic lymphoma\n  * Hodgkin's lymphoma.\n\n    * For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: :\n\n      * Documentation of HIV diagnosis in the medical record by a licensed health care provider;\n      * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \\[e.g., Truvada\\], which is exclusionary);\n      * HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating \\> 1000 RNA copies\u002FmL;\n      * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n* Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer.\n* The investigator determines that the participant (or his\u002Fher legally authorized representative \\[LAR\\]) has the ability to provide informed consent and the participant or LAR provides written informed consent.",{"count":136,"type":22},200,"This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)\u002Facquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.",[139,140,141,28,142,143,144,145,146,147,148,149],"Anal Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","HIV Infection","Lymphoma","Malignant Solid Neoplasm","Multicentric Castleman Disease","Plasmablastic Lymphoma","Recurrent Kaposi Sarcoma","Recurrent Lymphoma","Recurrent Plasmablastic Lymphoma","Transplant-Related Kaposi Sarcoma","2026-05-28",{"date":101,"type":42},{"date":153,"type":42},"2023-05-10",{"date":155,"type":22},"2035-08-31",{"name":157,"class":158},"AIDS Malignancy Consortium","NETWORK",8,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":82},"100616690","phase-2-recombinant-glycosylated-human-interleukin-7-cyt107-for-the-treatment-of-kaposi-sarcoma-in-participants-with-hiv-and-immune-non-response-regimenks-hiv-100616690","NCT07308886","Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)","Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-response (REGIMEN-KS HIV)","* INCLUSION CRITERIA:\n* Histologically confirmed KS by NCI Laboratory of Pathology (LP), with or without any prior systemic KS treatment\n* Participants with HIV infection\n* Age \\>= 18 years\n* All participants should have at least five (5) measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.\n* Participants with stage T1 KS with visceral involvement must:\n\n  * have any\u002Fall associated tumor associated symptoms \\\u003C= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 criteria and\u002For,\n  * require no immediate intervention (e.g., mild oozing of oral KS is allowed).\n* Participants did not receive prior systemic therapy for KS or received prior systemic therapy and currently are either plateau in response, relapsed disease, progressive disease (PD), or inadequate response to treatment. Note: Previous local therapy or radiation is not considered systemic therapy.\n* Participants must:\n\n  * have been on effective ART therapy for at least 2 months prior to the study drug initiation and\n  * have HIV VL \\\u003C= 100 copies\u002FmL and\n  * have persistent KS, affecting quality of life due to either T1 or T0 disease with inadequate disease regression on ART alone.\n* ECOG PS \\\u003C=3\n* Adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count (ANC) \\>= 500\u002FmcL\n  * platelets \\>= 50,000\u002FmcL\n  * hemoglobin (hgb) \\>= 8g\u002FdL\n  * total bilirubin \\\u003C= 1.5 institutional upper limit of normal (iULN) or \\\u003C3 x iULN for Gilbert s syndrome or HIV protease inhibitors\n* AST \\\u003C= 2.5 x iULN\n* ALT \\\u003C= 2.5 x iULN\n* CD4 T-cell count \\\u003C= 350\u002FmcL\n* Participants must be willing to co-enroll to protocol 17C0174 \"Molecular Characterization of Viral-associated Tumors, Tumors occurring in the Setting of HIV or other Immune Disorders and Castleman Disease\"\n* Participants with chronic hepatitis B virus (HBV) infection are eligible if they are on suppressive antiviral therapy.\n* Participants with a hepatitis C virus (HCV) infection must have an undetectable HCV VL due to prior treatment or natural resolution.\n* Women of child-bearing potential (WOCBP) and men able to father a child must agree to use an effective method of contraception (hormonal, barrier, surgical sterilization, abstinence) at the study entry, for the duration of study therapy, and for up to 4 months\n\nafter discontinuation of study drug.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-Participants who have not recovered from immune-related AEs due to prior therapy (i.e., have residual toxicities \\> Grade 1 per CTCAE v.6.0).\n\nNote: Participants with hypothyroidism managed by supplemental levothyroxine are eligible.\n\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese Hamster Ovary (CHO) cell products, chimeric or humanized antibodies or fusion proteins.\n* Participants must not have received chemotherapy, radiotherapy, or other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study drug.\n* Participants must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) or systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-alpha or IL-2, pomalidomide, or immune checkpoint inhibitors) within 2 weeks before initiation of study treatment.\n\nNote: Participants who have received acute, low dose of systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. The use of inhaled corticosteroids, and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.\n\n* History or risk of autoimmune disease, except for:\n\n  * the presence of laboratory evidence of autoimmune disease (e.g., history of positive antinuclear antibody \\[ANA\\] titer or lupus anticoagulant) without associated symptoms,\n  * clinical evidence of vitiligo or other forms of depigmenting illness; and\u002For,\n  * mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis).\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest x-ray.\n\nNote: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\n* History of allogeneic stem cell transplant and all other organ transplant.\n* Another prior or concurrent malignancy requiring active therapy\n* Active tuberculosis\n* Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening.\n* Participants must not have received prohibited therapies within 4 weeks before initiation of study treatment\n* Severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel.",{"count":168,"type":22},55,[117],"Background:\n\nKaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Having HIV can weaken the immune system and this can lead to KS. Weaker immune systems may be measured by low T cells (a type of immune cell). CYT107 is a human protein, made in a laboratory, that may help boost immunity, specifically by increasing T cells, in people with HIV-associated KS.\n\nObjective:\n\nTo see if CYT107 can shrink KS tumors.\n\nEligibility:\n\nPeople aged 18 years and older with HIV-associated KS.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their skin lesions will be measured. They will have an x-ray of their lungs. Their ability to perform everyday tasks will be reviewed. A sample of lesion tissue (biopsy) may be collected from the skin.\n\nCYT107 is injected into the muscle of the arm, buttocks, or lower thigh once a week for up to 4 weeks. Participants will receive the shots at the clinic. Blood and other tests will be repeated at each visit. KS lesions will be measured and photographed on the 1st and 4th visits.\n\nParticipants who improved after the first 4 weeks may have another 4-week treatment within a year.\n\nFollow-up visits will continue for 3 years.",[28],[173,174,95,175,176],"human herpesvirus 8","KS-associated herpes virus","Interleukin-7","Lymphoproliferative Disorder","2026-05-07",{"date":179,"type":42},"2026-05-08",{"date":181,"type":42},"2026-04-08",{"date":183,"type":22},"2037-01-31",{"name":80,"class":81},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":82},"100434753","phase-1-abemaciclib-in-patients-with-hiv-associated-and-hiv-negative-kaposi-sarcoma-100434753","NCT04941274","Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma","A Phase I\u002FII Study of Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma","* INCLUSION CRITERIA:\n* Participants must have Kaposi sarcoma confirmed by the Laboratory of Pathology, NCI\n* Measurable disease as follows:\n\n  * All participants in Groups 1, 2a, or 2b or 4 should have at least five measurable cutaneous KS lesions per AIDS Clinical Trials Group Oncology Committee (ACTG) criteria with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion and\u002For evaluable disease per RECIST criteria.\n  * Measurable disease by the criteria proposed by the AIDS Clinical Trials Group Oncology Committee.\n  * Participants in Group 3 must have Stage T1 KS with at least five measurable cutaneous KS lesions per ACTG criteria and\u002For evaluable disease per RECIST criteria.\n* Participants may be HIV positive or negative.\n* Participants must be able to swallow oral medications\n* For all groups, participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count \\>1,000\u002FmcL\n  * Platelets \\>75,000\u002FmcL\n  * Hemoglobin \\>= 8gm\u002FdL\n  * Total bilirubin \\\u003C= 1.5 upper limit of normal unless the participant is receiving a protease inhibitor known to be associated with increased bilirubin (e.g. atazanavir), in which case total bilirubin \\\u003C= 7.5 mg\u002FdL with direct fraction \\\u003C= 0.7\n  * AST\u002FALT \\\u003C3 X institutional upper limit of normal\n  * Creatinine within normal institutional limits OR\n  * Creatinine clearance \\>45 mL\u002Fmin\u002F1.73 m\\^2 as estimated by either Cockroft-Gault or 24-hour urine collection for participants with creatinine levels above institutional normal\n  * Cardiac ejection fraction \\> 45% by echocardiogram\n* Prior treatment as follows:\n\n  * Phase I: Participants must have received at least 1 prior line of systemic therapy for KS with either plateau in response, progressive disease, or inadequate response to treatment. Previous local therapy or radiation is not considered systemic therapy.\n  * Phase II:\n\n    * Group 2a: Individuals must have received at least 1 prior line of systemic therapy for KS with either plateau in response, relapsed disease, progressive disease, or inadequate response to treatment\n    * Group 2b: Individuals have not received prior systemic therapy for KS. Previous local therapy or radiation is not considered systemic therapy.\n    * Group 3: Evidence of Stage T1 KS with either a) edema or ulcerated KS and\u002For b) extensive oral KS and\u002For c) visceral KS involvement\n    * Group 4: Participants that received prior treatment with abemaciclib with evidence of response (at least a partial response per ACTG criteria and\u002For RECIST) to abemaciclib.\n* Participants in Cohort 4 must:\n\n  * have been previously enrolled in Cohorts 1-3\n  * have at least prior documentation of PR in prior cohort\n  * not have come off treatment for any \\>Grade 3 abemaciclib-related AE.\n* Age \\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2 (Karnofsky \\>= 60%.\n* Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.\n* Willingness to adhere to antiretroviral therapy (ART)\n* All participants must have received ART for 8 weeks prior to enrollment, with no evidence of KS improvement over the most recent 4 weeks\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV VL must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV VL.\n* No uncontrolled severe concurrent bacterial, viral, or fungal infections.\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* Contraception requirements as follows:\n\n  * Participants of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \\[IUD\\], hormonal, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 4 months after completion of abemaciclib administration\n  * Participants able to father a child must with partners of childbearing potential agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment for up to 4 months after completion of abemaciclib\n\nadministration. Individuals with partners of childbearing potential should ask their partners to be on an effective birth control (hormonal, IUD, surgical sterilization).\n\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with abemaciclib, nursing should be discontinued if the nursing person is treated with abemaciclib.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study.\n* Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.\n* Participants 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 or neuropathy.\n* Participants who are receiving any other investigational agents.\n* History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to CDK inhibitor.\n* Participants receiving any ART or other medications that are strong\u002Fmoderate inhibitors of CYP3A4 must have dose reductions per Strong\u002FModerate CYP3A4 inhibitors.\n* Serious and\u002For uncontrolled severe intercurrent illness that in the judgement of the investigator would preclude participation in the study.\n* No active KSHV-associated multicentric Castleman disease, KSHV-associated inflammatory cytokine syndrome or primary effusion lymphoma.\n* Psychiatric illness\u002Fsocial situations that would limit adherence with study requirements.\n* Pregnancy\n* Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial\n* Participants with interstitial lung disease",{"count":193,"type":22},111,[62,117],"Background:\n\nKaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help.\n\nObjective:\n\nTo find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors.\n\nEligibility:\n\nPeople ages 18 and older with KS.\n\nDesign:\n\nParticipants will be screened with some or all of the following:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nChest x-ray and\u002For computed tomography scans\n\nLung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ)\n\nMedicine review\n\nHeart function tests\n\nKS lesion assessment\n\nSkin sample from a KS lesion\n\nTreatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects. Participants who stopped taking abemaciclib because it was no longer providing additional benefit may be able to restart abemaciclib again.\n\nParticipants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed.\n\nParticipants will have follow-up visits for up to 2 years after treatment ends.",[28],[198,68,199,200,201],"Angiogenesis","cyclin-dependent kinase","KSHV","Cell Cycle","2026-05-02",{"date":204,"type":42},"2026-05-05",{"date":206,"type":42},"2021-09-29",{"date":208,"type":22},"2028-06-01",{"name":80,"class":81},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":82},"100638080","phase-2-low-dose-reduced-frequency-nivolumab-for-the-treatment-of-unresectable-or-metastatic-cancer-afford-io-trial-100638080","NCT07576725","Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial","AFFORD IO: A Phase 2 Trial of Low Dose, Reduced Frequency Nivolumab (Anti-PD-1 Antibody) in Patients With Unresectable or Metastatic Cancer","Inclusion Criteria:\n\n* Participants are eligible if they have one of these histologically confirmed, unresectable or metastatic cancer types listed below, based upon historical responsiveness to anti-PD-(L)1 agents\n\n  * Non-small cell lung cancer (NSCLC) with documented PD-L1 expression (combined positive score \\[CPS\\] ≥ 1) (NOTE: Participants with known driver oncogenic mutations\u002Frearrangements, including EGFR, ALK and ROS-1, will be excluded.)\n  * Head and neck squamous cell carcinoma (HNSCC) with documented PD-L1 expression (CPS ≥ 1)\n  * Clear cell renal cell carcinoma (ccRCC) (NOTE: Other subtypes may be permitted after approval by the Medical Monitor)\n  * Melanoma (cutaneous, acral-lentiginous and mucosal subtypes), and non-melanoma skin cancers, (cutaneous squamous cell carcinoma \\[CSCC\\], basal cell carcinoma \\[BCC\\] and Merkel cell carcinoma \\[MCC\\])\n  * Hodgkin's lymphoma\n  * Urothelial carcinoma\n  * Cervical cancer with documented PD-L1 expression (CPS ≥ 1)\n  * Colorectal cancer with high microsatellite instability (MSI) or mismatch repair deficiency\n  * Kaposi sarcoma (KS) without clinical concern for multicentric Castleman's disease (MCD)\n  * Any cancer type with historical data suggesting an ORR \\> 20% with anti-PD(L)-1 agents (NOTE: All participants in this category must be approved by the Medical Monitor prior to enrollment.)\n* Must have experienced disease progression after or deemed not to be a good candidate for available curative systemic therapy options\n* Presence of at least one measurable tumor, per RECIST v1.1\n* Age 18 or older. (NOTE: Both men and women, and members of all races and ethnic groups are eligible for this trial.)\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n* Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL\n* Platelet count ≥ 75 × 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL (NOTE: Participants may have been transfused)\n* Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) (or total bilirubin ≤ 2.5 × upper limit of normal \\[ULN\\] in participants with Gilbert's syndrome)\n* Estimated creatinine clearance ≥ 30mL\u002Fmin according to the Cockcroft-Gault formula or according to local institutional standard\n* Must consent to undergo serial research blood draws at study defined timepoints, unless deemed unsafe or not feasible by the treating investigator\n* Must have an ability to understand and provide consent to the institutional review board (IRB)-approved informed consent form (ICF) document(s)\n* Women of childbearing potential must have a negative serum or urine pregnancy test at screening\n* Both male and female participants must be willing to use highly effective contraception, as stipulated in national or local guidelines, throughout the study and for at least 180 days after the last treatment administration, if the risk of conception exists\n\nExclusion Criteria:\n\n* Prior exposure to any immune-checkpoint inhibitor for any reason\n* Residual adverse event(s) from prior therapy grade \\> 1 (National Cancer Institute \\[NCI\\]-Common Terminology Criteria for Adverse Events \\[CTCAE\\] v6.0) that could interfere with study endpoints or put participant safety at risk, as determined by the treating investigator\n* Known active central nervous system (CNS) metastases and\u002For prior history of leptomeningeal cancer involvement\n* Known history of another active malignancy (besides the eligible cancer diagnosis) within the last 3 years from day 1 of nivolumab that could interfere with study endpoints or put participant safety at risk. (NOTE: Exception will be made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ \\[skin, bladder, cervical, colorectal, breast\\] or low grade prostatic intraepithelial neoplasia or grade 1 prostate cancer. Any other neoplasm, which has been treated adequately and is adjudged by the treating investigator to have a low risk of progression during the study, could be enrolled only after approval from the medical monitor.)\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV), defined as follows:\n\n  * Active HBV is defined as a known positive hepatitis B virus surface antigen (HBsAg) result or positive total hepatitis B virus core antibody (anti-HBc) results in the absence of hepatitis B virus surface antibody (anti-HBsAb). (NOTE: When HBsAg is negative and HBcAb is positive, HBV-DNA should be measured. When HBV-deoxyribonucleic acid \\[DNA\\] is negative, this participant could be enrolled with close monitoring of HBV activities.)\n  * Active hepatitis C virus (HCV) is defined as a known positive HCV antibody result and quantitative HCV-ribonucleic acid (RNA) results greater than the lower limits of detection of the assay. (NOTE: Participants who have had definitive treatment for HCV are permitted if HCV-RNA is undetectable.)\n* Known uncontrolled HIV infection. (NOTE: HIV-infected participants may be allowed if all the following criteria are met: CD4 count ≥ 100\u002FμL, viral load less than 200 copies\u002FmL, and clinically stable on antiretroviral therapy \\[ART\\] for at least 3 months.)\n\n  * These participants will be enrolled only after approval from the medical monitor\n* Known active autoimmune disease or an allograft requiring systemic immunosuppression with corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent) or immunosuppressive drugs within the past 2 years before the first dose of nivolumab. (NOTE: Exceptions will be made for participants with autoimmune conditions such as diabetes type I, vitiligo, psoriasis, hypothyroid or hyperthyroid diseases not requiring immunosuppressive treatment; participants receiving physiologic corticosteroid replacement therapy at doses \\\u003C 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency; participants with a condition such as asthma or chronic obstructive pulmonary disease that requires intermittent use of steroids or those who require brief courses of corticosteroids for prophylaxis \\[e.g., contrast dye allergy\\], nivolumab-related standard premedication, and\u002For treatment of non-serious immune related adverse events. Any other situation must be discussed with the medical monitor for risk\u002Fbenefit assessment.)\n* Immunosuppressed status due to severe uncontrolled diabetes, concurrent uncontrolled hematological malignancy, or other comorbidities\n* Known history of serious, active infections (aside from well-controlled HIV, as per exclusion criterion #6) requiring systemic antimicrobial agents within 14 days before the first dose of nivolumab. (NOTE: Chronic infections such as herpes simplex virus requiring suppressive therapy may be allowed after discussion with the medical monitor for risk\u002Fbenefit assessment.)\n* Known history of clinically significant interstitial lung disease, or active noninfectious pneumonitis\n* Clinically significant (i.e., active) cardiovascular disease such as cerebral vascular accident or myocardial infarction within 6 months prior to first dose of nivolumab, ongoing unstable angina or congestive heart failure (New York Heart Association Classification class II-IV), or serious cardiac arrhythmia that could jeopardize participant safety on the study\n* Receipt of live vaccine(s) within 30 days of planned start of nivolumab. (NOTE: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster \\[chickenpox\\], yellow fever, rabies, bacillus Calmette Guerin \\[BCG\\], and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.)\n* Known severe acute or chronic medical conditions such as uncontrolled seizure disorder, serious psychiatric illness, or laboratory abnormalities, that may increase the risk associated with study participation or may interfere with the interpretation of study endpoints and, in the judgment of the treating investigator, would make the participant inappropriate for entry into this study\n* Known active tuberculosis (TB). (NOTE: Participants with latent TB will be allowed, provided they are receiving tuberculosis preventive therapy, after approval of the medical monitor.)\n* Known allergy or hypersensitivity to any component of the study drug formulation (including excipients and additives) that could interfere with study endpoints or put participant safety at risk\n* Pregnant or breast-feeding woman",{"count":218,"type":22},50,[117],"This phase II trial studies how well low dose, reduced frequency nivolumab works in treating patients with cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab is a type of immune checkpoint inhibitor (ICI). ICIs have revolutionized the treatment of numerous cancers with remarkable improvement in participant outcomes. However, accessibility of ICIs is extremely poor on a global scale, mainly due to high costs. Previous research has suggested that these drugs can be given at lower doses and reduced frequency than their approved dosing regimens, with similar results. Giving nivolumab at a lower dose and less often may help reduce the cost of therapy, improve immunotherapy accessibility, and therefore improve survival outcomes globally.",[222,223,224,225,226,28,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263],"Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8","Hodgkin Lymphoma","Metastatic Acral Lentiginous Melanoma","Metastatic Basal Cell Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Kaposi Sarcoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Merkel Cell Carcinoma","Metastatic Mucosal Melanoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Acral Lentiginous Melanoma","Unresectable Basal Cell Carcinoma","Unresectable Cervical Carcinoma","Unresectable Clear Cell Renal Cell Carcinoma","Unresectable Colorectal Carcinoma","Unresectable Cutaneous Melanoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Merkel Cell Carcinoma","Unresectable Mucosal Melanoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Urothelial Carcinoma","NOT_YET_RECRUITING","2026-05-01",{"date":179,"type":42},{"date":268,"type":22},"2026-09-01",{"date":270,"type":22},"2029-08-31",{"name":272,"class":49},"Fred Hutchinson Cancer Center",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":326,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":159},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":282,"type":22},28,[117],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,28,319,320,321,322,323,324,325],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Mesothelioma","Neuroblastoma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Hepatoblastoma","Fallopian Tube Neoplasms","Leiomyosarcoma","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Osteosarcoma","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Ovarian Epithelial Cancer","Soft Tissue Sarcoma","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[327,287,328,288,289,329,330,292,331,294,332,296,333,334,335,336,299,300,337,338,303,304,305,306,339,308,340,310,341,312,342,314,343,316,317,344,345,28,319,320,346,322,298,323,324,325],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Fallopian Tube Cancer","Vaginal Cancer","Gallbladder Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer",{"date":348,"type":42},"2026-04-15",{"date":350,"type":42},"2024-07-16",{"date":352,"type":22},"2028-05",{"name":354,"class":49},"Instituto do Cancer do Estado de São Paulo",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":82},"100550291","phase-2-propranolol-for-the-treatment-of-kaposi-sarcoma-in-adults-100550291","NCT06445166","Propranolol for the Treatment of Kaposi Sarcoma in Adults","A Multicenter Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Adults","Inclusion Criteria:\n\n* Biopsy proven Kaposi Sarcoma that is measurable with a millimeter ruler. Patients presenting for both front-line therapy and subsequent-line therapy will be considered.\n* Must have two lesions greater than or equal to 4 mm x 4 mm, or one lesion greater than or equal to 8 mm x 8 mm, that are accessible for 4-mm punch biopsy. The patient must have at least 5 more lesions in addition to the lesion(s) being biopsied.\n* At least 18 years of age.\n* Weight ≥40 kg\n* ECOG performance status ≤ 2\n* Meets the appropriate HIV-related criteria:\n\n  * If HIV positive, patient must be on antiretroviral therapy (ART) that conforms to local standards of care for at least 12 weeks. HIV positive patients will not be excluded based on CD4 count or HIV viral load.\n\n    * If on ART 12 to 24 weeks, must show evidence of KS progression requiring further systemic treatment.\n    * If on ART for \\> 24 weeks, must show no evidence of regression in the last 8 weeks.\n  * If HIV negative, must not show evidence of improvement in the 12 weeks prior to enrollment.\n* Propranolol is US FDA pregnancy category C. For this reason, women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for one month after completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, s\u002Fe must inform her treating physician immediately.\n* Able to take an oral pill.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Visceral disease causing functional impairment. Unless it is a minor, self-limiting (not affecting normal activities) condition.\n* Urgently clinically indicated for immediate cytotoxic chemotherapy. Patients who have received cytotoxic chemotherapy \\> 4 weeks prior to screening are eligible.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial\n* Currently taking beta-andrenergic antagonist(s) for other indications. Prior use is allowed if the last dose of the beta-andrenergic antagonist is ≥ 5 half-lives of the agent prior to Day -7.\n* Currently receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 4 weeks prior to receiving the first dose of propranolol.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to propranolol.\n* History of asthma or current diagnosis of obstructive airway disease such as asthma, COPD, or bronchiolitis. Patients with mild or well-controlled obstructive airway disease may be included as long as they have not had an acute episode in the last 3 mos requiring more than 4 days\u002Fmo of treatment, change of chronic treatment, or visit to medical personnel for treatment of asthma, COPD, or bronchiolitis.\n* History of diabetes mellitus, as defined by any of the following: A random blood glucose value of at least 200 mg\u002FdL in the presence of hyperglycemia symptoms (weight loss, blurry vision, thirst, polyuria), fasting plasma glucose value of at least 126 mg\u002FdL, A1c value of at least 7.0%, or two hour plasma glucose value of at least 200 mg\u002FdL during a 75 g oral glucose tolerance test.\n* History of uncompensated heart failure, severe sinus bradycardia (heart rate persistently \\\u003C50 beats per minute), sick sinus syndrome, or heart block greater than first degree. Patients with isolated bradycardia may be included as long as the heart rate is at least 51 beats per minute and is asymptomatic.\n* History of hypotension (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg) or orthostasis (\\>20 mmHg fall in systolic pressure or \\>10 mmHg fall in diastolic pressure with standing). (Isolated instances of hypotension may not be exclusionary after discussion with PI.)\n* Shortness of breath, hemoptysis, or moderate\u002Fsevere cough not attributable to causes other than KS. Patients may be included if they have a minor, self-limiting condition and their O2 sat is persistently greater than 90% and there is no hemoptysis or cough severe enough to limit normal activities.\n* Bleeding from the mouth or rectum not attributable to causes other than KS. Unless it is a minor, self-limiting condition, such as blood tinged toilet paper.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing clinically significant active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Concern for KSHV inflammatory cytokine syndrome. Patients with history of prior KSHV inflammatory cytokine syndrome may be included.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry.\n* Evidence of untreated chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with active HBV infection can be enrolled as long as they are receiving HBV treatment. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.",{"count":363,"type":22},25,[117],"Kaposi sarcoma (KS) lesions are initiated by endothelial cells infected with KS herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). Lesion progression is driven by abnormal angiogenesis, chronic inflammation, and uncontrolled cell proliferation. KS remains one of the most commonly diagnosed cancers in many African countries where economic constraints prevent successful treatment in most patients. Treatment outcomes in developed countries are also often unsatisfactory in HIV positive patients despite good virological and immunological responses to antiretroviral therapy. Therefore, identification of new oral, safe treatment options for treatment of KS remains a research priority. Given the known anti-angiogenic properties and based on the treatment response with other benign vascular lesions such as infantile hemangioma, propranolol is a good candidate for the treatment of KS. The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate plus partial response rate) of at least 45%, and that propranolol will be safe and well tolerated in this patient population.",[28],[368,369,370,371,95],"Propranolol","Kaposi","Sarcoma","Phase II","2026-03-31",{"date":374,"type":42},"2026-04-06",{"date":376,"type":42},"2025-08-20",{"date":378,"type":22},"2028-08-01",{"name":48,"class":49},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":15,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":82},"100573828","precision-imaging-to-evaluate-kaposi-sarcoma-prime-ks-a-device-feasibility-trial-100573828","NCT06751355","Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial","Eligibility Criteria:\n\n* Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (KS).\n* Patients may be off treatment or on treatment for their KS.\n* Has at least 3 cutaneous Kaposi sarcoma lesions.\n* At least 18 years of age.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.",{"count":387,"type":22},30,"While tremendous progress has been made against HIV, both in preventing the infection and in treating AIDS, the disease it causes, AIDS-related malignancies like Kaposi sarcoma (KS) remain a significant health burden, in both the U.S. and especially the developing world. In many cases, multiple KS lesions develop simultaneously, and may progress and regress independently. Photographs are an essential part of the evaluation for KS, as reflected in their formal usage described in the KS Tumor Assessment Manual of Procedures. However, acquiring a clear, informative photo is not trivial, since anatomy is 3D and conventional imaging is 2D. The importance of accurate, quantitative 3D information is especially pronounced for the treatment of KS because when a tumor responds positively to treatment, the initial change is usually a flattening of the lesion, without any significant change in the projected 2D area. To evaluate the vertical space, along with other characteristics of a KS lesion, we have created an innovative imaging system, SkinScan3D, utilizing new commercial liquid lens technologies and AI based image analysis software, with strategies borrowed from astronomical imaging techniques previously used on NASA space telescopes. In this study, the investigators will develop and demonstrate a protocol for recording measurable 3D parameters, which may be used in a longitudinal study to rigorously monitor therapeutic responses of KS and statistically compare with that of the conventional AMC criteria.",[28],[369,391,392,393],"Imaging","Photography","3D","2026-03-22",{"date":396,"type":42},"2026-03-25",{"date":398,"type":42},"2025-02-25",{"date":400,"type":22},"2028-07-31",{"name":48,"class":49},{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},"100385974","phase-2-trial-of-ixazomib-for-kaposi-sarcoma-100385974","NCT04305691","Trial of Ixazomib for Kaposi Sarcoma","A Phase 2 Trial of Ixazomib for Kaposi Sarcoma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants must have histologically or cytologically confirmed cutaneous Kaposi sarcoma. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be \\>= 700 mm\\^2\n* Participants must have documentation of HIV status. If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment. If HIV positive, documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care provider\n  * Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre exposure prophylaxis \\[PrEP\\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\> 1000 RNA copies\u002FmL\n  * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or Multispot HIV-1\u002FHIV-2 Rapid Test or HIV Antibody HIV-1\u002FHIV-2 Differentiation Assay\n\n    * Note: The term \"licensed\" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States \\[U.S.\\] Food and Drug Administration \\[FDA\\]). WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an extracellular interactome assay (E\u002FCIA )that is based on a different antigen preparation and\u002For different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 50%)\n* Life expectancy of greater than 3 months\n* Absolute neutrophil count: \\>= 1,000\u002Fmm\\^3 (within 21 days before enrollment)\n* Hemoglobin: \\> 8 g\u002FdL (within 21 days before enrollment)\n* Platelets: \\>= 75,000\u002Fmm\\^3 (within 21 days before enrollment). Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before study enrollment\n* Total bilirubin =\\\u003C 1.5 x the upper limit of the normal range (ULN) (within 21 days before enrollment)\n\n  * If the elevated bilirubin is felt to be secondary to indinavir or atazanavir therapy, then subjects will be allowed on protocol without any limit on the total bilirubin if the direct bilirubin is normal\n* Creatinine:\n\n  * Serum creatinine levels within normal institutional limits; or, creatinine clearance \\>= 30 mL\u002Fmin (as calculated per the Cockcroft-Gault Equation (within 21 days before enrollment)\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 6 months before study enrollment. To be eligible for this trial, participants must be class 2B or better within 6 months before enrollment\n* Ixazomib can cause fetal harm. For this reason and because proteasome inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control and another method such as hormone contraception simultaneously; abstinence) before study entry, the duration of study participation, and 90 days after completion of ixazomib 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. Men treated or enrolled on this protocol must also agree to use adequate contraception or abstain from heterosexual contact before the study, for the duration of study participation, and for 90 days after completion of ixazomib administration\n* If HIV positive, participants must have been on antiretroviral therapy (ART) with optimum anti-viral response for at least 12 weeks. Three-drug ART regimens which include a protease inhibitor or a nucleoside reverse transcriptase inhibitor are acceptable, as is the recently FDA-approved injectable ART regimen, cabotegravir with rilpivirine. Additional appropriate regimens in management of HIV as specified in https:\u002F\u002Fclinicalinfo.hiv.gov\u002F are acceptable as long as they do not include moderate or strong CYP3A4 inducers. Changes of antiretroviral therapy within the prior 12 weeks for toxicity\u002Fconvenience reasons are allowed (as long as participants are on a stable regimen for 4 weeks per Section 3.1.11). However, if changes in anti-HIV therapy are due to inadequate HIV control and occurred within the 3 months prior to protocol consent, the patient is not eligible until 12 weeks after optimal control is reached.\n* If HIV positive, must have been on a STABLE anti-retroviral therapy for at least 4 weeks. The non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz and etravirine are moderate CYP3A4 inducers which will reduce ixazomib exposure and are therefore prohibited. Potential participants requiring change of antiretroviral therapy to avoid moderate to strong CYP3A4 inducers or to pursue better HIV management with an alternate antiretroviral regimen should defer enrollment until completing 4 weeks of the new ART regimen. There should be no intention to change the regimen for the duration of the study.\n* HIV positive participants must not show recent improvement in KS on ART alone that may confound response evaluation, within the following parameters:\n\n  * If on ART 12 to 24 weeks, participants must show a burden of disease requiring further systemic KS-directed treatment (i.e. advanced cutaneous disease, presence of lymphedema or asymptomatic visceral disease, painful lesions) or evidence of KS progression:\n  * i.e. any new lesion(s);\n  * spreading of lesions by any measurable degree;\n  * development of ulceration;\n  * worsening edema documented by circumferential measure of limb or body;\n  * increase in symptoms such as pain, including negative psychological impact;\n  * any degree of disease worsening by imaging that would prompt expert assessment to recommend further systemic treatment with delay\n  * If on ART for \\>24 weeks, must show no evidence of regression in last 8 weeks\n* Patients who have residual active KS lesions (not merely tattoo effect) after receipt of recent KS-directed therapy are eligible to participate even if there was no interval progression since completion of therapy as long as: (1) the degree of residual disease merits systemic therapy (i.e. advanced cutaneous disease, presence of lymphedema or asymptomatic visceral disease, painful lesions)); and (2) at least 4 weeks have passed since receipt of the most recent KS-directed therapy.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or other agents used in study\n* Chronic systemic treatment using strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort is not allowed. Patients who are on chronic use of strong CYP3A inducers must come off 14 days before receiving ixazomib treatment. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the participant 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 participant is considering a new over-the-counter medicine or herbal product\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. This includes infections requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment but excludes ongoing antibiotic therapy for opportunistic infection (OI) prophylaxis\n* Participants with a second prior or concurrent malignancy that has a natural history or treatment regimen that has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Pregnant women are excluded from this study because ixazomib is expected to cause fetal harm if used during pregnancy. It is not known if ixazomib is excreted into breast milk, but due to the potential for serious adverse events in a nursing infant, breastfeeding must be discontinued during therapy and for 90 days after the last ixazomib dose\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before entering the study\n* Participants who have not recovered from other adverse events due to prior anti-cancer therapy (i.e., have residual toxicity \\> grade 1), excluding alopecia\n* Participants who are seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). All participants will be required to be screened for hepatitis B. Participants with resolved infection (i.e. participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and\u002For antibodies to hepatitis B surface antigen (anti-HBs) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV deoxyribonucleic acid (DNA) levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of hepatitis B virus (HBV) vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR\n* Participants diagnosed with hepatitis C who are hepatitis C antibody positive, whether hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests that conform to the protocol inclusion criteria\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing\n* Participants with grade 2 or higher peripheral neuropathy (i.e., painful neuropathy) on clinical examination during the screening period\n* Major surgery within 14 days before enrollment\n* Participants with symptomatic visceral Kaposi sarcoma\n* Participants who have had prior treatment of Kaposi sarcoma with a proteasome inhibitor within the last 2 years or with ixazomib at any time.",{"count":410,"type":22},41,[117],"This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[28,414],"Skin",[28,95,414,416],"ixazomib","2026-02-25",{"date":419,"type":42},"2026-02-27",{"date":421,"type":42},"2023-11-07",{"date":423,"type":22},"2029-03-15",{"name":157,"class":158},11,{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":446},"100500546","phase-2-a-study-of-propranolol-to-treat-kaposi-sarcoma-100500546","NCT05797662","A Study of Propranolol to Treat Kaposi Sarcoma","A Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Children and Adults","Inclusion Criteria:\n\n* Pediatric (\\\u003C 18 years) and adult (≥ 18 years) participants with biopsy-proven and measurable Kaposi Sarcoma (KS) as defined in the KS Manual of Procedures (MOP).\n* No urgent clinical indication for immediate cytotoxic chemotherapy. Participants who have received cytotoxic chemotherapy \\> 4 weeks prior to screening are eligible.\n* KS stage:\n\n  * \\\u003C 18 years:\n\n    * 1A (Mild): disease limited to skin, flat oral mucosal lesions, and\u002For flesh colored subcutaneous nodules, total \\\u003C10 lesions.\n    * 1B (Moderate): having any of the following features, alone or in combination: a total of 10-19 hyperpigmented skin\u002Foral lesions, nodular oral involvement, conjunctival eye involvement, or exophytic mass.\n  * ≥ 18 years:\n\n    * T0: confined to skin and\u002For lymph nodes and\u002For minimal oral lesions.\n    * T1: limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions.\n* Performance Status:\n\n  * \\\u003C 18 years:\n\n    * Lansky performance status \\> 70%\n  * ≥ 18 years:\n\n    * Easter Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have adequate organ function, as defined by the following:\n\n  * Bilirubin (direct or total) within normal range, or total bilirubin \\\u003C3.0 mg\u002Fdl for participants with Gilbert syndrome.\n  * Calculated creatinine clearance ≥ 30 mL\u002Fmin for participants ≥ 12 years (see Appendix III); creatinine \\\u003C1.5 Upper Limit Normal (ULN) for participants \\\u003C 12 years.\n  * Hemoglobin \\> 9 g\u002FdL;\n  * Platelets \\> 100 × 109\u002FL;\n  * ANC \\> 1000 cells\u002Fmm3\n* Human Immunodeficiency Virus (HIV) positive participants must be on antiretroviral therapy (ART) that conforms to local standards of care. Participants will have been on ART for at least 12 weeks. Participants will not be excluded based on CD4 count or HIV viral load.\n* HIV positive participants must not show recent improvement on ART that may confound response evaluation:\n\n  * If on ART 12 to 24 weeks, participants must show evidence of KS progression requiring further systemic treatment.\n  * If on ART for \\>24 weeks, must show no evidence of regression in the last eight weeks.\n* HIV-negative participants must not show evidence of improvement in the three months prior to enrollment.\n* No history of asthma or diabetes mellitus (as it is a risk factor for hypoglycemia).\n* No clinically significant cardiovascular disease other than hypertension, which is permitted.\n* No use of beta-adrenergic antagonists for other indications.\n* Not pregnant or planning to become pregnant. Propranolol is United Stats Food and Drug Administration (US FDA) pregnancy category C. At this time, the study team has determined that the unknown risk to a developing fetus is greater than the potential benefit of treatment.\n* Use of effective contraception for women of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months.\n* Women of child bearing potential (WOCBP) must agree to use adequate contraception (oral contraceptive pills, intrauterine device, Nexplanon, Depo-Provera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) prior to study entry, for the duration of study participation.\n* Not breast feeding.\n\nExclusion Criteria:\n\n• Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. Additionally, the presence of any of the following conditions will exclude a participant from study enrollment:\n\n* Children and adolescents with lymph node or visceral disease, woody edema, or ≥ 20 cutaneous lesions.\n* Children and adolescents with heart rate or systolic blood pressure \\\u003C10th percentile for age.\n* Adults with visceral disease or tumor-associated edema causing functional impairment.\n* Shortness of breath, hemoptysis, or moderate\u002Fsevere cough not attributable to causes other than KS.\n* Bleeding from the mouth or rectum not attributable to causes other than KS.\n* Treatment for active and serious infection.\n* Children with severe acute malnutrition based on World Health Organization (WHO) criteria (Mid-upper arm circumference \\\u003C11.5 cm, weight-for height Z-score \\\u003C-3 or presence of symmetrical pitting edema).\n* Given the risk of hypotension and hypoglycemia, participants must take the study drug with food. If needed, the study team will pursue additional funding to support providing supplemental food for participants who experience food insecurity.\n* Patients who experienced hypersensitivity to propranolol during initiation phase of treatment or had previous known allergy to propranolol or allergy to other β-blockers.\n* Patients with a history of uncompensated heart failure; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree.\n* Patients with diagnosed obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.\n* History of diabetes mellitus (as it is a risk factor for hypoglycemia)\n* Patients receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 30 days prior to receiving the first dose of investigational treatment.\n* Patients with concern for Kaposi Sarcoma herpesvirus (KSHV) inflammatory cytokine syndrome.",{"count":363,"type":22},[117],"A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.",[28],[28,368],"2026-01-22",{"date":440,"type":42},"2026-01-23",{"date":442,"type":22},"2026-09",{"date":444,"type":22},"2029-04",{"name":157,"class":158},9,{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":470,"leadSponsor":472,"locationsCount":4},"100470851","phase-3-paclitaxel-and-pegylated-liposomal-doxorubicin-for-treatment-of-hiv-related-kaposi-sarcoma-100470851","NCT05411237","Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma","A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings","Inclusion Criteria:\n\n1. HIV-1 infection.\n2. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist.\n3. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR\n\n   Stage T0 KS that has progressed or not responded after a minimum of 12 weeks of treatment with ART. Participants with T0 KS must have either:\n   * 20 or more skin and\u002For oral KS lesions, and\u002For\n   * any number of lesions on exposed body areas that have an adverse effect on quality of life (e.g., stigmatization).\n4. Men and women ≥ 18 years. Because no dosing or adverse event data are currently available on the use of PTX or PLD for AIDS-KS in persons \\\u003C18 years of age, children are excluded from this study\n5. Karnofsky performance status ≥ 60 (ECOG ≤ 2).\n6. Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%.\n7. Ability and willingness of participant or legal guardian to provide informed consent.\n8. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression.\n9. Measurable cutaneous KS, defined as follows:\n\n   * When available, a minimum of five bi-dimensionally measurable KS cutaneous marker lesions.\n   * If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be ≥ 700mm2.\n10. The following laboratory values obtained within 14 days prior to study entry:\n\n    * Absolute Neutrophil Count ≥ 1000 cells\u002Fmm3.\n    * Hemoglobin ≥ 8 g\u002FdL (may be achieved with transfusion if clinically indicated, in the opinion of the investigator).\n    * Platelet count ≥ 75,000\u002Fmm3.\n    * ALT, AST, Alkaline phosphatase \\\u003C 5 × upper limit of normal (ULN).\n    * Total bilirubin: ≤ 1.5 × ULN, unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be ≤ 2 x the ULN.\n    * Creatinine \\\u003C institutional ULN OR estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n11. Women of reproductive potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months), must have a negative pregnancy test done within 24 hours of initiating the protocol-specified chemotherapy medication.\n12. Participants must agree to use two reliable forms of contraception simultaneously while receiving study protocol-specified medication and for 6 months after stopping the medication.\n13. Adequate venous access.\n14. No prior chemotherapy or use of systemic cytotoxic therapy agents.\n15. Participant is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and\u002For is not clinically stable.\n2. Serious illness necessitating hospitalization\u002Fsystemic treatment within 14 days prior to study entry\n3. Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant.\n4. Known history of congestive heart failure and\u002For systolic ejection fraction \\\u003C 50%.\n5. Prior radiotherapy to KS indicator lesions\n6. Prior or current immunotherapy\n7. Any immunomodulator, HIV vaccine, live attenuated vaccine, other investigational vaccine within 30 days prior to study entry, excluding vaccines against COVID-19\u002FSARS-CoV-2, which are permitted.\n8. Known allergy\u002Fhypersensitivity to the study drug or its formulation\n9. Any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n10. Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.\n11. Patients with psychiatric illness and\u002For social circumstances that would limit compliance with study requirements.",{"count":455,"type":22},130,[457],"PHASE3","This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.",[28,460,461],"HIV-1-infection","AIDS-related Kaposi Sarcoma",[463,464,465,466,467],"Paclitaxel","Pegylated liposomal doxorubicin","AIDS associated Kaposi Sarcoma","Human Immunodeficiency Virus","HIV-related Kaposi Sarcoma",{"date":440,"type":42},{"date":442,"type":22},{"date":471,"type":22},"2030-09",{"name":157,"class":158},{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":18,"minAge":480,"maxAge":481,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":489,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":82},"100516399","ayahiv-role-based-responsibilities-for-oncology-focused-workforce-arrow-100516399","NCT06004011","AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)","Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia","Inclusion Criteria:\n\n* 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration\n\nExclusion Criteria:\n\n* pregnant at study enrolment","15 Years","39 Years",{"count":483,"type":22},4100,[25],"Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort. In this study, the investigators will test peer-to-peer education and support strategies to increase use of early diagnosis services in HIV treatment facilities and improve compliance with cancer treatment in the cancer center.",[487,28,488],"Cervical Cancer","Non Hodgkin Lymphoma",[490,491],"cancer screening","Implementation trial","2026-01-13",{"date":494,"type":42},"2026-01-15",{"date":496,"type":42},"2024-05-01",{"date":498,"type":22},"2027-07-31",{"name":500,"class":49},"Implenomics",{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":530,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":542},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":509,"type":22},56,[62],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[513,514,515,516,517,518,519,520,521,28,522,523,524,289,525,526,527,528,529],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Cutaneous Neoplasm","Advanced Cancer","Metastatic Cancer","Refractory Cancer","Solid Tumor",[513,514,515,516,518,519,520,521,28,522,523,524,289,525,526,527,528,531,532,533,529],"MQ710","Memorial Sloan Kettering Cancer Center","22-278","2025-12-02",{"date":536,"type":42},"2025-12-03",{"date":538,"type":42},"2023-05-04",{"date":540,"type":22},"2028-05-04",{"name":532,"class":49},7]