Safety Study of SEA-CD40 in Cancer Patients
CarcinomaNon-Small-Cell Lung27 moreThis study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced...
MelanomaMerkel Cell Carcinoma5 morePatients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 results of the study, the decision was made not to start the Phase 2 part of the study and the study was terminated.
AMG 319 in HPV Positive and Negative HNSCC
Human Papillomavirus (HPV)Positive or Negative Head and Neck Squamous Cell Carcinoma (HNSCC) of the Hypopharynx3 moreThe purpose of this study is to determine whether a drug called AMG 319 has an effect on a patient's own immune response to head and neck cancer squamous cell carcinoma (HNSCC). This study is specifically for patients who are having surgery to treat their HNSCC
AVID100 in Advanced Epithelial Carcinomas
Solid TumorAdult3 moreApproximately 90 male and female patients with documented solid tumor malignancies of epithelial origin that are locally advanced or metastatic, and either refractory to standard therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a, multicenter, open-label, dose-escalation, cohort study of AVID100. Phase 2a will include evaluation of patient with EGFR-overexpressing squamous histology non-small cell lung cancer, squamous cell carcinoma of the head and neck, and triple negative breast cancer
A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With...
Head and Neck Squamous Cell CarcinomaIt's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck squamous cell carcinoma (HNSCC) patients. Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended intratumor injection volumes of PEP503. Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18 additional patients will be enrolled at the recommended volume level to evaluate for safety and efficacy.
Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head...
Metastatic Head-and-neck Squamous-cell CarcinomaThis phase 2 study is designed to evaluate the safety and activity of TH-4000, a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.
Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and...
Head and Neck Squamous Cell CarcinomaThis phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, 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.
A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid...
MelanomaNon-small Cell Lung Cancer3 moreThe goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells. PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study, PLX3397 and pembrolizumab are being given together in order to study their combined effects on patients' immune responses to their tumors. Tumor-specific immune responses have been shown to kill cancer cells and/or to stop tumors from growing. Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include an evaluation of efficacy of this combination in the following tumor types: Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as defined by irRECIST while on therapy Non-small cell lung cancer Ovarian cancer Gastrointestinal Stromal Tumor (GIST) Squamous cell cancer of the head and neck
Safety Study of AMG 228 to Treat Solid Tumors
Advanced MalignancyAdvanced Solid Tumors9 moreThe purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Phase II Study of RAD001 Head and Neck Cancer
Squamous Cell Carcinoma of the Head and NeckTo carry out exploratory studies to determine if activity of this regimen correlates with tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate with activity of this regimen and provide exploratory insights in to the mechanism of this treatment approach. Expression of the pathway components including EGF-R and phosphorylated EGF-R (p-EGF-R), ERK and p-ERK, Akt and p-Akt(T308 and S473), p70s6k and p-p70s6k, S6 and p-S6, HIF-1-alpha, p27 and 4E-BP1 will be assessed. Mutation and FISH analysis for EGF-R expression will also be performed on tumor samples. Biopsies will be obtained at the following times: pre-treatment, and after 4 weeks (one cycle) of treatment. If available, original diagnostic tissue may be submitted in place of the pre-treatment biopsy.