https://clinicaltrials.gov/ct2/show/NCT01915225
May 20th, 2022 - Background: Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies. As Surgical Oncologists at the NCI, we ha...
https://clinicaltrials.gov/ct2/show/NCT04662710
May 20th, 2022 - There will be 2 parts to the study: a Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (Safety Run-in), approximately 12 participants will be treated with lenvatinib in combination with pembrolizumab and chemotherapy with either capecitabine and oxaliplatin (CAPOX), or 5-fluorouracil (5-FU), Leucovorin, and oxaliplatin (mFOLFOX6). Participants will be closely followed for dose-limi...
https://clinicaltrials.gov/ct2/show/NCT04645160
May 20th, 2022 - Background: Cholangiocarcinoma (CCA) is an aggressive biliary tract malignancy that remains a clinical challenge with limited treatment options and poor survival. Combination chemotherapy with gemcitabine and cisplatin is the most validated first-line treatment, but the response rate approaches only 22% and median progression free survival is 8 months. Cytoplasmic accumulation of the nuclear ex...
https://clinicaltrials.gov/ct2/show/NCT04707248
May 20th, 2022 - DS-6000a is an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of DS-6000a into the cells. MAAA-1181a that is released from DS-6000a in the target cells inhibits cell replication and induces cell apoptosis. This study will evaluate DS-6000a given as a single agent once every 21 days. The dose escalation phase will e...
https://clinicaltrials.gov/ct2/show/NCT02194738
May 20th, 2022 - PRIMARY OBJECTIVES: I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to facilitate accrual to randomized adjuvant studies. II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced g...
https://clinicaltrials.gov/ct2/show/NCT04739800
May 20th, 2022 - PRIMARY OBJECTIVE: I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by progression-free survival (PFS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who ...
https://clinicaltrials.gov/ct2/show/NCT00923026
May 20th, 2022 - Background: Patients receiving care at the NIH Clinical Center are required to be enrolled on a clinical protocol. Following participation in a treatment protocol, it may be in the best interest of the patient to continue to be followed at the Clinical Center. The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug A...
https://clinicaltrials.gov/ct2/show/NCT03866382
May 20th, 2022 - PRIMARY OBJECTIVE: I. To evaluate the efficacy of cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting for patients within each of the rare genitourinary (GU) variant histology group of interest, as measured by objective response rate (ORR). SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) for patien...
https://clinicaltrials.gov/ct2/show/NCT03801915
May 20th, 2022 - Background: Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative, and patients frequently succumb to disease recurrence in the ensuing months to year(s) after the operation. Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer little demonstrable decreases in the rates of tumor recurrence. The concept and implementation of immediate...
https://clinicaltrials.gov/ct2/show/NCT03937830
May 20th, 2022 - Background: Worldwide, hepatocellular carcinoma (HCC) is the fourth most common cause of cancer related death with a median survival of 6-9 months. Biliary tract carcinoma (BTC) is relatively uncommon and includes cancers of the gallbladder and intra- and extra-hepatic biliary ductal system, although periampullary tumors are often considered part of this group as well. A class of agents that in...
https://clinicaltrials.gov/ct2/show/NCT04974671
May 20th, 2022 - This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment. Alternative local therapy (including but not limited to metastectomy or radiofrequenc...
https://clinicaltrials.gov/ct2/show/NCT00646022
May 20th, 2022 - Study Description: This study is designed as a prospective evaluation for diagnostic screening, genotyping and natural history of participants belonging to kindreds with familial carcinoid tumor. Objectives: Primary Objective: Study the natural history of familial carcinoid tumors: incidence, age of onset, symptoms, the appropriate diagnostic (biochemical and imaging) modalities, location, hist...
https://clinicaltrials.gov/ct2/show/NCT04071223
May 20th, 2022 - PRIMARY OBJECTIVE: I. To assess the symptomatic skeletal event (SSE)-free survival of metastatic renal cell cancer (mRCC) patients with bone metastases treated with cabozantinib S-malate (cabozantinib) + radium Ra 223 dichloride (radium-223 dichloride) compared to cabozantinib alone. SECONDARY OBJECTIVES: I. To investigate the safety, toxicity and tolerability as defined by Common Terminology C...
https://clinicaltrials.gov/ct2/show/NCT04027946
May 20th, 2022 - Background: Mesothelin is expressed in approximately half of all lung adenocarcinomas. LMB-100 has demonstrated anti-tumor efficacy against several mesothelin expressing tumor models including non-small cell lung cancer (NSCLC).- Programmed death ligand 1 (PD-1) is an Ig superfamily member related to CD28 and CTLA-4 that has been shown to negatively regulate antigen receptor signaling upon enga...
https://clinicaltrials.gov/ct2/show/NCT03778957
May 20th, 2022 - This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy
https://clinicaltrials.gov/ct2/show/NCT02649868
May 20th, 2022 - Background: Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide. Management of hepatic malignancies from primary Hepatocellular Carcinoma (HCC) or metastatic disease involves a multidisciplinary approach of surgery and chemotherapy and in the case of HCC, transplant, anti-VEGF sorafenib, or local or regional image guided therapie...
https://clinicaltrials.gov/ct2/show/NCT01660984
May 20th, 2022 - Background: Medullary Thyroid Carcinoma (MTC) is a calcitonin producing tumor arising from the parafollicular C cells of thyroid. In children and adults, MTC is usually seen in association with Multiple Endocrine Neoplasia (MEN) 2A and 2B, which are rare cancer syndromes resulting from germline mutations of Rearranged during Transfection (RET) proto-oncogene. MTC develops in virtually all patie...
https://clinicaltrials.gov/ct2/show/NCT04538378
May 20th, 2022 - Background: Targeted therapies designed for specific genetic alterations, known as cancer driver mutations, have changed the treatment paradigm in advanced non-small cell lung carcinoma (NSCLC). Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective in NSCLC with activating mutation in the EGFR. Although most patients achieve robust responses to EGFR TKIs with t...
https://clinicaltrials.gov/ct2/show/NCT01130519
May 20th, 2022 - Background Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) is a familial cancer syndrome characterized by a propensity for developing renal cancer, and uterine and cutaneous leiomyomas. The kidney cancer associated with HLRCC is clinically aggressive and is characterized by unique histopathologic features that are sometimes described as type 2 papillary RCC. Germline mutations in the fu...
https://clinicaltrials.gov/ct2/show/NCT04523493
May 20th, 2022 - This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC. Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvati...
