A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
Cervical CancerGastric Cancer19 moreThe purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors
Non Small Cell Lung CancerUrothelial Carcinoma6 moreIn this phase I first-in-humans-study a vaccine consisting of arginase-1 (ARG1) peptides and the adjuvant Montanide ISA-51 will be tested in ten patients with metastatic solid tumors. Patients will be treated with an ARG1 vaccine every third week for 45 weeks.
Prognostic Impact of Tumor Growth Velocity in Head and Neck Squamous Cell Carcinoma Treated by Radio(Chemo)Therapy...
Head and Neck Squamous Cell CarcinomaTumor GrowthThe purpose of this study is to determine the impact of tumor growth velocity on the survival of patients with hea and neck squamous cell carcinoma treated by (chemo-)radiotherapy. Patients with stages I to IV oropharyngeal primary squamous cell carcinoma (OPSCC) elected for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume and number and size of pathological neck lymph nodes (small diameter > 1 cm) will be assessed on diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the summation of areas technique. Tumor progression and tumor doubling time will be calculated based on DiCT and RtCT. Tumor proliferation will be assessed on biopsy specimens by Ki67 immunohistochemistry and mitotic index. HPV status will be evaluated by PCR and p16 immunohistochemistry. Ulcerative or exophytic aspect will be noticed. Tumoral kinetics patterns will be correlated with disease free survival and overall survival of patients with HNSCC. These patterns will be compared to HPV status and proliferation markers in order to study their clinical signification [time frame: 5 years] and develop predictive markers of tumor progression for head and neck cancers.
Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma...
LipOral Cavity and Pharynx1 moreThis randomized pilot early phase I trial studies how well nivolumab with or without tadalafil work in treating patients with head and neck squamous cell carcinoma that has come back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Tadalafil may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and tadalafil may work better in treating patients head and neck squamous cell carcinoma.
A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC...
Premalignant LesionHead and Neck Squamous Cell Carcinoma (HNSCC)This is a multicenter minimal risk or burden prospective 3-cohort follow-up and monitoring study that aims to collect clinical, socio-psychological, medico-economics data and biospecimens for patients with oral potentially malignant lesions (OPML) or resectable head and neck squamous cell carcinoma (HNSCC) : Cohort A: OPML patients. Cohort B (specific design): smokers (adults who have smoked at least 100 cigarettes in their lifetime) motivated to quit - either current smokers (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smokers (adults who have smoked at least 100 cigarettes in their lifetime, but say they currently do not smoke) who stops smoking within 3 months prior to the diagnosis - with a resectable HNSCC requiring postoperative radiotherapy or chemoradiation. Cohort C: Patients with resectable HNSCC non-eligible to cohort B. The primary objective of this study is the identification of biomarkers (predictive of malignant transformation or second primary tumor) and new strategies for prevention and therapy, mainly through extensive genomic, epigenomic and immune characterization of OPML and HNSCC.
Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.
Ovary CancerCervix Cancer7 moreThe purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.
Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma
Oral Squamous Cell CarcinomaUp to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. Funding Source: FDA OOPD
Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced...
Squamous Cell Carcinoma of the Head and NeckPhase II trial evaluating to assess the feasibility and efficacy as first-line therapy for patients with non-resectable locally advanced HPV negative HNSCC of Durvalumab a PDL1-Inhibitor plus Tremelimumab a CTLA-4- Inhibitor in combination with radiotherapy and Durvalumab in combination with radiotherapy as first-line therapy. 2-arm, randomized, multicenter, phase II. Step 1 is Registration. All patients need to sign the informed consent form for registration. Tumor tissue then be send to the central lab for defining the HPV status. If the patient is HPV negative the site will be notified if they can further proceed to patient randomization. Step 2 is Randomization of all eligible patients with a centrally diagnosed, HPV negative tumor in one of the two arms (Durvalumab plus Tremelimumab + radiotherapy; Durvalumab + radiotherapy) after signing the informed consent form for step 2.
ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing...
Oral Cavity NeoplasmOropharyngeal Neoplasm12 moreThis randomized phase IIb trial studies how well ACTOplus met extended release (XR) works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or coming back. The use of ACTOplus met XR may slow disease progression in patients with oral cavity or oropharynx cancer.
Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage...
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v710 moreThis phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation therapy may work better in treating patients with squamous cell carcinoma of the head and neck.