Sentences with phrase «randomized phase iii»

Primary overall survival from OPTiM, a randomized phase III trial of talimogene laherparepvec (T - VEC) versus subcutaneous granulocyte - macrophage colony - stimulating factor (GM - CSF) for the treatment of unresected stage IIIB / C and IV melanoma.

The drug, a monoclonal antibody called ipilimumab, is the first treatment of any kind ever shown in a large, randomized phase III clinical study (study MDX010 - 20) to improve overall survival in patients with metastatic melanoma who no longer respond to standard therapy.

Low - Dose ATLG Prevents GVHD in Pediatric Hematologic Malignancies: A newly published randomized phase III study of pediatric patients showed lower doses of rabbit anti — T - lymphocyte globulin (ATLG) was superior to a higher dose in children with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation from an unrelated donor.

In 2005, the chemotherapy temozolomide (Temodar ®) was approved to treat newly diagnosed GBM patients based on a randomized phase III clinical study that showed that it added 2.5 months to the median survival of patients.

The randomized phase III study included 180 patients aged 0 to 18 years with hematologic malignancies who underwent transplant from an unrelated donor selected using high - resolution typing for HLA - class I / II loci.

She served on the End Point Response Committee for the Blood and Marrow Transplant Clinical Trials Network national randomized phase III clinical trial for treatment of chronic GVHD.

A Randomized Phase III Study of Brentuximab Vedotin (SGN - 35, IND # 117117) for Newly Diagnosed High - Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

Risk - Stratified Randomized Phase III Testing of Blinatumomab (IND # 117467, NSC # 765986) in First Relapse of Childhood B - Lymphoblastic Leukemia (B - ALL)

PALLAS: Palbociclib Collaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR +) / Human Epidermal Growth Factor Receptor 2 (HER2)- Negative Early Breast Cancer

Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC

This study, «Final Results of Local - Regional Control and Late Toxicity of RTOG 9003: A Randomized Trial of Altered Fractionation Radiation for Locally Advanced Head and Neck Cancer,» is a multi-institutional, randomized Phase III trial of fractionation in locally advanced head and neck cancer.

«There is a significant possibility that local therapy, such as consolidative radiation, may become an important part of the management of limited metastatic NSCLC patients, but this validation must take place in randomized phase III studies.

A randomized phase III trial finding that a new monoclonal antibody, elotuzumab, added to standard therapy, extended the duration of remission for patients with relapsed multiple myeloma by about five months Findings from two phase III studies showing that children with Wilms tumor who have a specific chromosomal abnormality do better with a more intensive, augmented chemotherapy regimen

Not exact matches

The HYPO - RT - PC trial, a randomized multi-institutional phase III trial in Scandinavia, was designed to assess outcomes from highly accelerated extreme hypofractionation, which is delivered in smaller number of high doses — seven fractions of 6.1 Gy each in this study.

Luznik says that the researchers» next step will be to test the short course therapy in a phase III randomized clinical trial that would directly compare results in patients who receive the cyclophosphamide treatment with those who receive either a separate, experimental approach to prevent GVHD or the more traditional six - month immunosuppressive therapy.

He identified 193 Phase III randomized trials — the gold standard in clinical research — for analysis.

TRINOVA - 1 was a randomized prospective phase III clinical trial that added trebananib or placebo to standard chemotherapy (weekly paclitaxel) among 919 women with recurrent ovarian cancer patient from 179 sites in 32 countries.

PRIME 2 is an international, phase III, randomized, controlled trial that set out to address the question of whether whole - breast radiotherapy can be omitted in carefully defined groups of older patients receiving appropriate therapy.

It is the first and largest phase III randomized controlled trial of stable, synthetic human angiotensin II.

The researchers plan to carry out phase III randomized controlled clinical trials to determine the actual rate of effectiveness by comparing those treated with the ketogenic diet to a group tube - fed a normal, nonketogenic diet.

The Phase III clinical trial, conducted by the Radiation Therapy Oncology Group (RTOG), randomized 637 patients at multiple centers, including the University of Maryland Greenebaum Cancer Center, into two groups.

«To evaluate these findings in a group with only one HER2 treatment, we are currently analyzing data from another clinical trial, the GeparQuinto clinical trial, which is a randomized, phase III clinical trial evaluating two different neoadjuvant therapy regimens with a single anti-HER2 treatment [trastuzumab or lapatinib] for women with HER2 - positive breast cancer,» said Loibl.

A Randomized, Multicenter, Double Blind, Phase III Study of Nivolumab or Placebo in Subjects with Resected Lower Esophageal, or Gastroesophageal Junction Cancer

A Phase III Randomized Trial for Newly Diagnosed High Risk B - precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND # 73789, NSC # 606869) in the Very High Risk Stratum

14255: STAT3 Signaling During Chemo - Radiation for Squamous Cell Carcinoma of the Head and Neck 14340: A Phase II, Randomized, Open - Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) 14258: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza) versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration - Resistant Prostate Cancer who have Failed Prior Treatment with a New Hormonal Agent and have Homologous Recombination Repair Gene Mutations.

Phase III Randomized, Placebo - Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy + / - One Year of Everolimus in Patients with High - Risk, Hormone Receptor - Positive and HER2 / neu Negative Breast Cancer.

A Phase III, Multicenter, Randomized, Placebo - Controlled, Double - Blind Study Of Atezolizumab (Anti − PD - L1 Antibody) As Adjuvant Therapy In Patients With Renal Cell Carcinoma At High Risk Of Developing Metastasis Following Nephrectomy

A Randomized, Phase III Trial to Evaluate The Efficacy and Safety of MK - 3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor - Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (yPN +) After Neoadjuvant Chemotherapy

A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB (> or = 4 cm)- IIIA Non-Small Cell Lung Cancer (NSCLC)

A Phase III, Multicenter, Randomized, Placebo - Controlled Study of Atezolizumab (ANTI − PD - L1 Antibody) as Monotherapy and in Combination with Platinum - Based Chemotherapy in Patients with Untreated Locally Advanced or Metastatic Urothelial Carcinoma

A Phase III Randomized Open - Label Multi-Center Study of Ruxolitinib vs. Best Available Therapy in Patients with Corticosteroid - Refractory Chronic Graft vs Host Disease after Allogenic Stem Cell Transplantation (REACH 3)

In that randomized, double - blind, placebo - controlled, phase III trial, 561 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who were in complete or partial response to platinum - based chemotherapy were treated with either rucaparib 600 mg orally twice daily (372 patients) or to placebo (189 patients).

Phase III randomized study of sorafenib (IND 69896, NSC 724772) plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II / III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC # 737754, IND # 118613)

The COLUMBUS trial was a randomized, open - label, phase III trial that took place in 28 countries.

RESCUE and REVERSE are two separate randomized, double - masked, sham - controlled pivotal Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.

REFLECT is a randomized, double - masked, placebo - controlled Phase III trial evaluating the safety and efficacy of bilateral injections of GS010 in patients with < 1 year of onset of vision loss in LHON.

Mature results of a phase III randomized trial of bacillus Calmette - Guerin (BCG) versus observation and BCG plus dacarbazine versus BCG in the adjuvant therapy of American Joint Committee on Cancer stage I - III melanoma (E1673).

The bottom line is that if a drug can not pass the rigorous phase I to phase III trials required by the FDA (which are usually double blind, randomized, and controlled for all known variables that could influence the outcome), it will not be approved.