Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell Carcinoma1 moreThis is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.
Intralesional Cemiplimab for Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma...
Cutaneous Squamous Cell CarcinomaBasal Cell CarcinomaThe primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC) The secondary objectives of this study are: To describe the objective response rate (ORR) in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC, according to modified World Health Organization (WHO) criteria To describe the pathologic complete response (CR) rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC To describe the major pathologic response rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with CSCC or BCC To assess the immunogenicity of cemiplimab in patients with CSCC or BCC To establish a recommended dose of intralesional cemiplimab for further study in patients with CSCC or BCC
Rigosertib for RDEB-SCC
Epidermolysis Bullosa DystrophicaSquamous Cell CarcinomaEpidermolysis bullosa (EB) is a heritable skin disease characterized by marked fragility of epithelialized tissue with blistering in skin and mucous membranes following the slightest mechanical trauma. Eighty percent of all patients suffering from recessive dystrophic EB (RDEB), a subtype originating from mutations in the COL7A1 gene, develop squamous cell carcinoma (SCC). In RDEB patients SCC presents early (most patients are in their 20s or 30s) and shows a highly aggressive metastatic course which often leads to premature death at this young age. In light of scarce data on the efficacy and safety of systemic treatment regimens for advanced SCC, the investigators propose to perform a small, "first in EB " trial of an experimental drug called rigosertib for the treatment of EB cancer. The trial will be conducted in two study centres, in London and Salzburg, and will last approximately 2.5 years with each patient recruited being in the study for 1 year. The drug is a polo-like kinase inhibitor interfering with different molecular pathways that are essential for cancer cell growth. Rigosertib was developed by Onconova Therapeutics and is currently tested in several clinical trials for a number of other cancers including myelodysplastic syndrome (a cancer of the blood). The investigators have identified that rigosertib most selectively kills EB cancer cells in vitro while leaving normal EB skin cells unaffected. This project will evaluate whether rigosertib is capable of inducing an anti-cancer response in EB patients and whether the drug is well-tolerated. Mechanisms of molecular targeting of squamous cancer cells by rigosertib will further be investigated in EB patients, also aiming at the identification of biomarkers that may allow the predictive identification of best responders.
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer...
Bladder AdenocarcinomaBladder Clear Cell Adenocarcinoma43 moreThis phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally...
CarcinomaSquamous CellThis is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With...
Cutaneous Squamous Cell CarcinomaThe primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Stage IV Esophageal AdenocarcinomaStage IV Esophageal Squamous Cell Carcinoma42 moreThis phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.
Trial of Nivolumab and Cetuximab After Chemoradiation in Esophageal Squamous Cell Carcinoma Patients....
Esophageal Squamous Cell CarcinomaThis is a phase II, open label, two-centered study for evaluation of the addition of nivolumab and cetuximab after chemoradiation as a neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma patients. Subjects must have received no prior treatment for esophageal cancer (chemotherapy, radiotherapy or surgery) and no prior treatment with checkpoint inhibitors. Eligible subjects will receive induction chemotherapy with cetuximab for a period of 4 weeks, chemoradiation with cetuximab for a period of 6 weeks, 3 cycles of immunotherapy (nivolumab + cetuximab) for a period of 6 weeks, and will undergo surgery at the end of the treatment.
A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma...
HPV-Related Squamous Cell CarcinomaThis is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.
Radiotherapy With Pembrolizumab in Metastatic HNSCC
Head and Neck Squamous Cell CarcinomaRandomized phase II study of immune stimulation with Pembrolizumab and radiotherapy in second line therapy of metastatic head and neck squamous cell carcinoma.