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147 active trials for Nasopharyngeal Carcinoma

Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

This pilot randomized clinical trial studies how well bupropion hydrochloride works compared with patient's choice for quitting smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may help patients quit smoking by enhancing central nervous system neurotransmitters noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride is more effective than patient's choice in helping quit smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy.

Start: January 2016

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. 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. This trial enrolls participants for the following cohorts based on condition: Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018) Epithelial tumors of major salivary glands (closed to accrual 03/20/2018) Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) Undifferentiated carcinoma of gastrointestinal (GI) tract Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018) Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018) Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018) Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible (closed to accrual) Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018) Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018) Sarcomatoid carcinoma of lung Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018) Trophoblastic tumor: A) Choriocarcinoma (closed to accrual) Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual) Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual) Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis (closed to accrual) Squamous cell carcinoma variants of the genitourinary (GU) system Spindle cell carcinoma of kidney, pelvis, ureter Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018) Odontogenic malignant tumors Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual) Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017) Pheochromocytoma, malignant (closed to accrual) Paraganglioma (closed to accrual 11/29/2018) Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual) Desmoid tumors Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018) Malignant giant cell tumors Chordoma (closed to accrual 11/29/2018) Adrenal cortical tumors (closed to accrual 06/27/2018) Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017) Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019) Adenoid cystic carcinoma (closed to accrual 02/06/2018) Vulvar cancer (closed to accrual) MetaPLASTIC carcinoma (of the breast) (closed to accrual) Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018) Perivascular epithelioid cell tumor (PEComa) Apocrine tumors/extramammary Paget's disease (closed to accrual) Peritoneal mesothelioma Basal cell carcinoma (temporarily closed to accrual 04/29/2020) Clear cell cervical cancer Esthenioneuroblastoma (closed to accrual) Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) Clear cell endometrial cancer Clear cell ovarian cancer (closed to accrual) Gestational trophoblastic disease (GTD) Gallbladder cancer Small cell carcinoma of the ovary, hypercalcemic type PD-L1 amplified tumors Angiosarcoma High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible (closed to accrual) Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)

Start: January 2017

Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma

This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.

Start: April 2019

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

Start: March 2021

Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC. With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above. In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible. This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.

Start: October 2017

Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.

Start: May 2019

Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma

The purpose of this study is to test the hypothesis that a combined Immuno-Oncology (IO) strategy would see efficacy in a virally driven cancer like Nasopharyngeal Carcinoma (NPC). Hence, this is a combination study of nivolumab and ipilimumab in Epstein-Barr virus (EBV) driven nasopharyngeal carcinoma.

Start: March 2017

Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma

The standard of care for locally advanced nasopharyngeal carcinoma is radical chemoradiation(CRT).Recent advances in radiation techniques and supportive measures resulted in improvemnent of locoregional control and quality of life.However distant failure is still the main challenging reason of poor survival Addition of systemic therapy to concurrent CRT is widely used and accepted as an option to reduce these failures ,however selection of chemotherapy regimen and timing in relation to CRT is controversial. Doublet and triplet chemotherapy regimens using cisplatin and 5FU are throughly investigated in this setting.Inspite of significant improvement in disease free survival and overall survival they were poorly tolerated.Hence,minority of patients in the daily practice could tolerate those studied regimens as propsed. Recently, in multicenter randomized trial, Zhang and his group investigated gemcitabine and cisplatin as induction chemotherapy (ICT) added to CRT.It showed improvement in recurrence free survival and overall survival.More importantly 96.7% of the experimental arm completed the treatment protocol. This was further confirmed by an updated network of meta analysis by Bongiovanni et al.Again the question of "when" is still valid.Our proposal is to compare tolerable regimen in induction versus adjuvant settings.

Start: May 2021

An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.

Start: July 2021

A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.

Start: May 2019

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.

Start: May 2019

Evaluating the Rationality of the International Guideline About Selective Coverage of Level Ib in CTV With NPC

The purpose of this study was to evaluate its rationality in real-world data and provide clinical evidence for the refinement of nodal CTV delineation in nasopharyngeal carcinoma(NPC).

Start: May 2021

A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

Start: July 2018

Neoadjuvant Therapy of GP Chemotherapy Combined With Tislelizumab in Locoregionally Advanced NPC

The purpose of this study is to explore the efficacy and safety of a combination of GP chemotherapy and tislelizumab in neoadjuvant therapy of locoregionally advanced nasopharyngeal carcinoma patients.

Start: April 2021

Magnifying NBI for Occult NPC

Diagnosis of nasopharyngeal carcinoma (NPC) is currently made by trans-nasal endoscopy and biopsy. The small caliber endoscope provides only a limited view of the nasopharynx and may not be able to provide a thorough assessment of the nasopharynx. The investigators have developed a novel endoscopic approach to access the nasopharynx by using a trans-oral high definition endoscope with magnification and image enhancement function. In this cohort study, we aim to investigate the efficacy of diagnosing NPC by applying the novel technique in a high risk patient group with elevated plasma EBV DNA but with negative screening with conventional trans-nasal endoscopy.

Start: April 2021

Nasopharyngeal Carcinoma Post IMRT

Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients. This is an observational study that is being done to learn about the long-term symptoms and side effects that survivors of nasopharyngeal cancer may have following radiation treatment. This study will include assessment of patient report outcomes, physician-graded adverse events, neurocognitive assessment and endocrine and hearing testing

Start: June 2015

EPstein-barr Virus DNA Response to Systemic Therapy for Treatment Adaptation in High Risk NPC (EP-STAR)

The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient . For patients with detectable EBV DNA after one cycle of IC, which then drops to undetectable levels during the following IC cycles (intermediate responders/intermediate relapse risk), the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup. For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase (insensitive to IC/high relapse risk), the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases (including concurrent phase and adjuvant phase) can benefit this subgroup.

Start: June 2020

Nedaplatin in Treatment for Nasopharyngeal Carcinoma

To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

Start: May 2021

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

Start: August 2020

Pembrolizumab and Olaparib in Recurrent/Metastatic, Platinum Resistant Nasopharyngeal Cancer

Recurrence rate after curative treatment for locally advanced Nasopharyngeal carcinoma (NPC) is reported varying from 15% to 30% of cases, while approximately 5-11% of patients present with de novo metastatic disease. In NPC, the immunogenicity of the cancer cell is derived from accumulated somatic mutations, but also from genomic and proteomic differences between host and Epstein Barr Virus (EBV). However, anti-cancer immune response tends to be feeble. This impaired anti-cancer immunity could be attributed to multiple factors including strategies to escape anti-cancer immunity. One of this is switch to immunosuppressive microenvironment, as well as aberrant negative co-stimulatory signals like PD-L1, that is over expressed in NPC. In 2017, the landmark KEYNOTE-028 trial firstly reported promising antitumor activities and safety profiles of pembrolizumab in previously treated RM-NPC Overall, after the treatment of PD-1 inhibitors, about 25% and 60% of the recurrent or metastatic nasopharyngeal carcinoma patients achieved ORR and DCR, respectively, with a profile of toxicities in line with the use of immune checkpoint inhibitors in other diseases. Recently, it was found that some non-BRCA-mutated tumors often harbor other alterations in HR genes except for germline BRCA deleterious mutations, thus making these tumors could benefit from PARPi treatment. PARP could contribute to resistance to chemotherapy induced DNA damage, NPC cell platinum resistant could use PARP to repair and escape apoptosis. In nasopharyngeal carcinoma PARP1 is overexpressed in comparison with normal nasopharyngeal cells, LMP1 (latent membrane protein one) activates PARP1 and increases Poly(ADP-ribos)ylation (PARylation) through PARP1. A preclinical study demonstrates that LMP1+ cells are more sensitive to PARP1 inhibition. After receiving PARPi treatment, accumulated chromosome rearrangements generate plenty of neoantigens and elevate the immunogenicity of tumor, PARPi-mediated acute inflammation remodels tumor immune microenvironment and drives a systemic Th1-skewing immune response. Patients in the POINT trial will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week dosing cycle (Q3W) and olaparib 300 mg capsules twice a day (BID) every day starting from Day 1 of Cycle 1. Treatment with protocol therapy will continue until objective disease progression, any prohibitive toxicity or until a maximum of 35 treatment cycles (up to 2 years).

Start: June 2021