Clinical trials: Monoclonal
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Clostridium Difficile Infection
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with MK-6072 or MK-3415A in addition to standard of…
- Trial name
- MODIFY II (NCT01513239)
- Testing
- MK-6072, MK-3415A, SOC
- Volunteers
- 1,203 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's…
- Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma
- Trial name
- NCT00012298
- Testing
- rituximab, yttrium Y 90 ibritumomab tiuxetan, indium In 111 ibritumomab tiuxetan
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- National Cancer Institute (NCI)
Hodgkin Lymphoma, Anaplastic Large-cell Lymphoma
A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with…
- Trial name
- NCT01950364
- Testing
- brentuximab vedotin, Brentuximab vedotin and rifampicin
- Where
- 6 sites in Belgium, Lithuania and 1 more
- Volunteers
- 20 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Asthma
A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma…
- Trial name
- NCT00768079
- Testing
- Benralizumab
- Where
- 11 sites in United States, Canada
- Volunteers
- 110 people
- Sponsor
- MedImmune LLC
Advanced Cancer
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.
- Trial name
- NCT03110107
- Testing
- Ipilimumab, BMS-986218, Nivolumab
- Where
- 52 sites in United States, Argentina and 15 more
- Volunteers
- 376 people
- Sponsor
- Bristol-Myers Squibb
Lymphoma, B-Cell
Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).
- Trial name
- NCT00577629
- Testing
- cyclophosphamide, etoposide, rituximab
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Duke University
Kidney Transplant
Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants).
- Trial name
- NCT01213329
- Testing
- Alemtuzumab
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Northwestern University
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with…
- Trial name
- NCT00408629
- Testing
- adalimumab
- Where
- 108 sites in United States, Argentina and 16 more
- Volunteers
- 518 people
- Sponsor
- Abbott
Leukemia, Lymphocytic
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells.
- Conditions
- Leukemia, Lymphocytic, Chronic
- Trial name
- NCT00077922
- Testing
- LMB-2
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Cancer Institute (NCI)
Pancreatic Cancer
Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing…
- Trial name
- NCT00042939
- Testing
- cetuximab, docetaxel, irinotecan hydrochloride
- Volunteers
- 94 people
- Sponsor
- Eastern Cooperative Oncology Group
Myeloma, Multiple, Myeloma-Multiple
Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
Background: Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured.
- Trial name
- NCT03910439
- Testing
- Avelumab, External beam radiotherapy
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Cancer Institute (NCI)
Aplastic Anemia, Pure Red Cell Aplasia
A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure
Participants in this study are suffering from rare and serious blood disorders. In aplastic anemia, the bone marrow stops producing red blood cells, platelets, and white blood cells.
- Conditions
- Aplastic Anemia, Pure Red Cell Aplasia, Diamond Blackfan Anemia
- Trial name
- NCT00001962
- Testing
- Daclizumab
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Carcinoma, Non-Small-Cell Lung
Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)
Primary objective of the study's Safety run-in: To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab, and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).
- Trial name
- CERTO (NCT00842712)
- Testing
- Cilengitide, Cetuximab, Cisplatin
- Where
- 44 sites in Belgium, Czechia and 6 more
- Volunteers
- 232 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Advanced Solid Tumors
Study Investigating Safety, Tolerability, Pharmacokinetics (PK) and Antitumor Activities of Anti-PD-1 (Programmed Death-1) Monoclonal Antibody
This was a dose verification, pharmacokinetic (PK) assessment of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP; FMP: Final Manufacturing Process) and indication expansion clinical study of…
- Trial name
- NCT04068519
- Testing
- Tislelizumab
- Where
- 12 sites in China
- Volunteers
- 300 people
- Sponsor
- BeiGene
Indolent Systemic Mastocytosis
Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis
Background: Mast cells help the body fight disease and heal wounds. People with indolent systemic mastocytosis (ISM) make too many mast cells. This causes pain, tiredness, digestive problems, and other symptoms.
- Trial name
- NCT03770273
- Testing
- sarilumab
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Arthritis, Juvenile Idiopathic
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or…
- Trial name
- NCT00048542
- Testing
- OLE BSA Adalimumab +/- MTX, OLE FD Adalimumab +/- MTX
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 171 people
- Sponsor
- Abbott
Migraine
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could…
- Trial name
- HER-MES (NCT03828539)
- Testing
- Erenumab, Topiramate
- Where
- 79 sites in Germany
- Volunteers
- 777 people
- Sponsor
- Novartis Pharmaceuticals