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There is nothing wrong with dark pools. I use one every day. It's when they are used for illegal reasons that they are a problem, and they do make that easier...but they are very important to institutions that are trading the right way and conducting legitimate business.
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Correction posted to Yonemura v Powers last night:
https://www.pacermonitor.com/public/case/9970453/Yonemura_v_Powers_et_al
I can't see what it is, no subscription
It's happening to me now too. Well, I have a lot of them saved if we end up needing them.
Try a different browser or clear your cache. It's working fine in chrome.
Sorry, children and young adults. I am wondering if it is going to roll into the entire population?
This is just the treatment for children. I have not seen anything stopping the adult treatments, have you?
Here is how the text looked prior to the update
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Trial record 7 of 9 for: dcvax
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Dendritic Cell-Autologous Lung Tumor Vaccine and Nivolumab in Treating Patients With Recurrent Glioblastoma
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Jonsson Comprehensive Cancer Center
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT03014804
First received: November 30, 2016
Last updated: January 5, 2017
Last verified: November 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This phase II trial studies the side effects of dendritic cell-autologous lung tumor vaccine and nivolumab and to see how well they work in treating patients with glioblastoma that has come back. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell-autologous lung tumor vaccine and nivolumab may work better in treating patients with glioblastoma.
Condition Intervention Phase
Giant Cell Glioblastoma
Gliosarcoma
Oligodendroglioma
Recurrent Glioblastoma
Small Cell Glioblastoma
Biological: Dendritic Cell-Autologous Lung Tumor Vaccine
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Evaluating Combination Therapy Using DCVax-L (Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen) and Nivolumab (an Anti-PD-1 Antibody) for Subjects With Recurrent Glioblastoma Multiforme
Resource links provided by NLM:
Genetics Home Reference related topics: lung cancer
MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Nivolumab
Genetic and Rare Diseases Information Center resources: Glioblastoma Gliosarcoma Oligodendroglioma Glioma Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
Incidence of adverse events assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Will be compared between groups and to those reported for historical standards, including subjects treated with nivolumab in prior trials.
Overall Survival (OS) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
The overall survival curves will be displayed using a Kaplan-Meier curve for the pooled and individual treatments. A one-sample log-rank test will also be completed as a sensitivity analysis for the same survival rate assumption as the primary efficacy analysis, and a two-sample log-rank test will be used to compare the survival distribution between the two arms.
Secondary Outcome Measures:
Overall Survival rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The overall survival curves will also be displayed using a Kaplan-Meier curve for the pooled and individual treatments. Estimated proportions of surviving subjects at 9 months will be provided along with the two-sided 95% CIs.
Overall Survival rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The overall survival curves will also be displayed using a Kaplan-Meier curve for the pooled and individual treatments. Estimated proportions of surviving subjects at 12 months will be provided along with the two-sided 95% CIs.
Overall Survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
The overall survival curves will also be displayed using a Kaplan-Meier curve for the pooled and individual treatments. Estimated proportions of surviving subjects at 18 months will be provided along with the two-sided 95% CIs.
Progression Free Survival (PFS) [ Time Frame: From treatment initiation to first progression or death assessed up to 12 months. ] [ Designated as safety issue: No ]
Kaplan Meier estimates will be provided along with the one-sided 95% lower bound on the survival rate. PFS survival will be compared between groups using a log-rank test.
Quality of Life (QoL) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Will be summarized descriptively for available subjects, and shifts from day 0 will be summarized for post-baseline assessments using the European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QoL) questionnaire.
Number of participants with complete response (CR) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of CR will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Number of participants with partial response (PR) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of PR will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Number of participants with stable disease (SD) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of SD will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Number of participants with progressive disease (PD) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of PD will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Objective response rate (ORR) defined as the percentage of participants with CR + PR [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of ORR will be provided at fixed intervals where tumor size is evaluated.
Response/Stable Disease Rate (RSDR) defined as the percentage of participants demonstrating CR+PR+SD [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of RSDR will be provided at fixed intervals where tumor size is evaluated.
Other Outcome Measures:
Changes in PET in lymph nodes [ Time Frame: Baseline up to 12 months ] [ Designated as safety issue: No ]
Correlated with TIL density or clonality, clinical outcome, T cell measures in peripheral blood and clinical toxicity. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Changes in PET in organ tissue [ Time Frame: Baseline up to 12 months ] [ Designated as safety issue: No ]
Correlated with tumor infiltrating lymphocytes (TIL) density or clonality. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Changes of PET in tumor [ Time Frame: Baseline up to 12 months ] [ Designated as safety issue: No ]
Correlated with TIL density or clonality, clinical outcome, T cell measures in peripheral blood and clinical toxicity. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Effect of nivolumab on peripheral blood lymphocyte and TIL proliferation (CD8+/Ki-67+ staining) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Difference in Progression Free Survival (PFS) of participants treated with combination treatment (Group 1) versus single treatment (group 2) [ Time Frame: Up to 12 months follow up after initiation of treatment ] [ Designated as safety issue: No ]
Difference in the rates of contrast-enhanced tumor change over time of participants treated with combination treatment (Group 1) versus single treatment (group 2) [ Time Frame: Up to 12 months follow up after initiation of treatment ] [ Designated as safety issue: No ]
Difference in Overall Survival (OS) of participants treated with combination treatment (Group 1) versus single treatment (group 2) [ Time Frame: Up to 12 months follow up after initiation of treatment ] [ Designated as safety issue: No ]
Difference in Landmark survival at 9 month of participants treated with combination treatment (Group 1) versus single treatment (group 2) [ Time Frame: Up to 9 months follow up after initiation of treatment ] [ Designated as safety issue: No ]
Difference in Landmark survival at 12 month of participants treated with combination treatment (Group 1) versus single treatment (group 2) [ Time Frame: Up to 12 months follow up after initiation of treatment ] [ Designated as safety issue: No ]
Difference in Landmark survival at 18 month of participants treated with combination treatment (Group 1) versus single treatment (group 2) [ Time Frame: Up to 18 months follow up after initiation of treatment ] [ Designated as safety issue: No ]
Number of somatic mutations in each pre-treatment tumor sample [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Correlated with T lymphocytic response in tumor after DCVax-L +/- nivolumab. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Oligoclonal T cell populations within tumor tissue [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
The magnitude of morphological changes correlated with clinical responses. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Association of Progression Free Survival (PFS) and Overall Survival (OS) with MGMT methylation status [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
The difference of PFS and OS between participants with methylated MGMT promotor and participants with unmethylated MGMT promotor enrolled in each treatment group
Analysis of PD-L1 membrane protein expression level on monocytes in two groups [ Time Frame: from baseline, up to 12 months follow up ] [ Designated as safety issue: No ]
Difference in expression level on monocytes at baseline and over time (Week 8, the End of Treatment, month 6 and month 18) compared between two groups
PD-1 and PD-L1 immunohistochemical expression [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Immunohistochemical staining (IHC) will be used to determine the difference in expression between archived tumor tissue samples and on study tumor tissue samples. Archived tumor tissue samples and on study tumor tissue samples are obtained in paraffin blocks or FFPE tissue slides, and are processed by IHC technique for antitumor expression of PD-1 and PD-L1. Multi-plex IHC stained will be performed to assess: 1) the proportion of PD-L1 expression on GFAP+ tumor cells versus myeloid cells (CD68+ or CD163+) within the tumor microenvironment; and 2) the proportion of PD-1 expression on CD4 or CD8 TIL; and 3) the proximity of CD4/8 TIL to PD-L1+ cells in the tumor microenvironment.
PD-1 and PD-L1 immunohistochemistry density [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Immunohistochemistry will be used to measure the difference in PD-1 and PD-L1 expression between density with clinical responses to combination therapy examined. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
PD-1 and PD-L1 immunohistochemistry clonality [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Immunohistochemistry will be used to measure the difference in PD-1 and PD-L1 expression between clonality with clinical responses to combination therapy examined. Descriptive statistics, confidence intervals, or inferential analyses will comprise a set of exploratory analyses.
Evaluate the effects of the study treatment on CD4+/8+ T cell ratios in two groups [ Time Frame: From baseline up to 12 months of follow up ] [ Designated as safety issue: No ]
Fluorescence-activated cell sorting assay will be used to measure T CD4+/8+ T cell ratios
Evaluate the effects of the study treatment on T cell subset proliferation and populations in two groups [ Time Frame: From baseline up to 12 months of follow up ] [ Designated as safety issue: No ]
Fluorescence-activated cell sorting assay will be used to measure T cell subset proliferation and population
Evaluate the effects of the study treatment on negative costimulatory molecule expression in two groups [ Time Frame: From baseline up to 12 months of follow up ] [ Designated as safety issue: No ]
Fluorescence-activated cell sorting assay will be used to measure negative costimulatory molecule expression
Estimated Enrollment: 30
Study Start Date: April 2017
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (DCVax-L)
Patients receive dendritic cell-autologous lung tumor vaccine ID on days 0, 7, 14, and weeks 4, 6, 8, 11, 14, 17 and 20.
Biological: Dendritic Cell-Autologous Lung Tumor Vaccine
Given ID
Other Name: DCVax-Lung
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Experimental: Group II (DCVax-L, nivolumab)
Patients receive dendritic cell-autologous lung tumor vaccine as in Group I, and nivolumab IV over 30 minutes on days 0, 14, and weeks 4, 6, 8, 11, 14, 17, and 20.
Biological: Dendritic Cell-Autologous Lung Tumor Vaccine
Given ID
Other Name: DCVax-Lung
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Nivolumab
Given IV
Other Names:
BMS-936558
MDX-1106
NIVO
ONO-4538
Opdivo
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Show Detailed Description
Eligibility
Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
PRE-SURGERY SCREENING PROCESS
Original diagnosis of glioblastoma multiforme (GBM) confirmed by central review
Radiographic evidence of first recurrence per Response Assessment in Neuro-Oncology (RANO) criteria confirmed by central review
Surgically accessible, unilateral, recurrent GBM tumor for which extirpative resection, with intent to perform a gross total or near gross total resection, is indicated; a subject may be screened if he or she has had a previous biopsy and is scheduled for a subsequent gross or near gross total resection prior to commencement of other therapies
Ability to understand and sign the tumor procurement informed consent form indicating awareness of the investigational nature of this study; the consent for tumor tissue donation may be signed by a legally authorized representative (LAR) if allowed by the institution
Life expectancy of >= 12 weeks
Absolute lymphocyte count >= 0.6 x 10^3/mm^3 (0.6 x 10^9/L)
MGMT promoter methylation status of original tumor is obtainable
POST-SURGERY, PRIOR TO PRE-LEUKAPHERESIS
Therapy for recurrent disease must have consisted of surgical resection extending beyond biopsy only, with the intent to achieve gross or near-total resection of the contrast-enhancing tumor mass; subjects who underwent resection confirmed beyond biopsy remain eligible for the screening process; subjects undergoing a biopsy only will be excluded; central confirmation is required before the subject can proceed to leukapheresis
Patients with recurrent unilateral GBM, confirmed through central pathology (grade IV), without metastases, remain eligible for this protocol
For the purposes of this study, pathology reports for all histologically confirmed GBM includes the recognized variants of glioblastoma (small cell glioblastoma, giant cell glioblastoma, gliosarcoma, and glioblastoma with oligodendroglial components)
All subjects must have sufficient tumor lysate protein generated from the resected tumor tissue; this determination will be made by the sponsor's contracted manufacturer and communicated to the clinical site through the sponsor or its designee; this confirmation is not required prior to the pre-leukapheresis visit, but is required before the subject can proceed to leukapheresis
PRE-LEUKAPHERESIS EVALUATION
Hemoglobin > 10 g/dL (100 g/L)
White blood cell count 3.6-11.0 x 10^3/mm^3 (3.6-11.0 x 10^9/L)
Absolute granulocyte count >= 1.5 x 10^3/mm^3 (1.5 x 10^9/L)
Absolute lymphocyte count >= 1.0 x 10^3/mm^3 (1.0 x 10^9/L)
Platelet count >= 100 x 10^3/mm^3 (100 x 10^9/L)
Eligibility is maintained if these laboratory results are outside of the central laboratory's normal reference ranges or the sample ranges provided above but are not deemed clinically significant by the treating investigator
Eligibility level of hemoglobin can be reached by transfusion; these values are determined by a central laboratory
Serum glutamate pyruvate transaminase (SGPT) =< 4.0 times upper limits of normal (ULN)
Serum glutamic-oxaloacetic transaminase (SGOT) =< 4.0 times ULN
Alkaline phosphatase =< 4.0 times upper limits of normal (ULN)
Total bilirubin =< 1.5 mg/dL (25.7 umol/L)
Blood urea nitrogen (BUN) =< 1.5 times ULN
Creatinine =< 1.5 times ULN
Subjects must have a Karnofsky performance status (KPS) rating >= 70 at the pre-leukapheresis visit
PRIOR TO DAY 0
Subjects may have received steroid therapy as part of their primary treatment; steroid treatment should be stopped or, if continued steroid use is clinically indicated, be tapered down to no more than 2 mg dexamethasone per day (or equivalent) at least 7 days prior to the first immunization
White blood cell count >= 2.0 x 10^3/mm^3 (2.0 x 10^9/L)
Neutrophils >= 1.5 x 10^3/mm^3 (1.5 x 10^9/L)
Platelets >= 100 x 10^3/mm^3 (100 x 10^9/L)
Hemoglobin >= 9.0 g/dL (90 g/L)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
SGOT (aspartate aminotransferase [AST]) =< 3 x ULN
SGPT (alanine aminotransferase [ALT]) =< 3 x ULN
Total bilirubin =< 1.5 x ULN
Except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL
Subjects must have a KPS rating a >= 60 at the pre-enrollment evaluation
Exclusion Criteria:
PRE-SCREENING
Progression on imaging based on RANO criteria within 12 weeks of conclusion of radiotherapy
History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 5 or more years prior to surgery
History of active, known, or suspected autoimmune or immunodeficiency disease
Known human immunodeficiency virus (HIV)-1 or -2 or human T-cell lymphotropic virus (HTLV)-1 or -2 positivity
Active uncontrolled infection, such as a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc
Known intolerance to cyclophosphamide or other alkylating agents, or any component of any study drug
History of active immunotherapy, including dendritic cell therapy, T cell therapy, immunization with tumor antigens in any form, any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways or checkpoint inhibitor therapy such as ipilimumab
History of severe infusion-related reaction to any biologics therapy
Females who are gravid or breast-feeding
Inability to obtain informed consent because of psychiatric or complicating medical problems
Any known genetic cancer-susceptibility syndromes
Any positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicative of acute or chronic infection
AT OR AROUND SURGERY
Bilateral or metastatic glioblastoma detected at diagnosis, during surgery, or at post-surgical magnetic resonance imaging (MRI); tumors may cross into, but not beyond, the corpus callosum
Postoperative MRI evidence of biopsy only, without significant tumor resection, confirmed by central reviewer
Implantation of Gliadel wafers (polifeprosan 20 with carmustine implant) at surgery
PRE-LEUKAPHERESIS VISIT
Positive HIV-1, -2, or HTLV-1, -2 tests
Recipient of organ allografts
Allergies to reagents used in this study
Unable to stop or taper steroid treatment to no more than 2 mg of dexamethasone per day (or equivalent) prior to leukapheresis; steroid use should be stopped or tapered down to the lowest clinically acceptable dose approximately 7 days prior to leukapheresis; the leukapheresis visit must be scheduled to occur a minimum of 21 days before the projected day 0
It is critical to reduce steroid administration to the lowest possible dose, as steroids interfere with DCVax-L manufacturing by hampering the ability of monocytes to adhere to plastic surfaces during purification; leukapheresis should occur at least 21 days prior to the projected date of DCVax-L administration
Inability or unwillingness to return for required visits and follow-up exams
EXCLUSION PRIOR TO DAY 0
Fewer than 6 doses of DCVax-L available for administration
Continued requirement for medications that might affect immune function; the following are exceptions: nonprescription strength doses of NSAIDS, acetaminophen (paracetamol), or acetylsalicylic acid (aspirin)
Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy; antibiotic therapy must be completed at least 7 days prior to the first DCVax-L/nivolumab administration
Fever >= 101.5 degrees Fahrenheit (F) (38.6 degrees Celsius [C]); if considered possibly transient, retesting is allowed
Unstable or severe intercurrent medical conditions
Women of child-bearing potential (WOCBP) who are pregnant or lactating or who are not using adequate contraception and willing to do so to avoid pregnancy for 5 months after the week 20 visit
Males who are sexually active with WOCBP and not willing to use any contraceptive method with a failure rate of less than 1% per year for 7 months after the week 20 visit
Any dose of steroids exceeding 10 mg/day of prednisone (or equivalent) within 2 weeks prior to study drug administration
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03014804
Locations
United States, California
UCLA / Jonsson Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Timothy F. Cloughesy 310-825-5321
Principal Investigator: Timothy F. Cloughesy
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Timothy Cloughesy UCLA / Jonsson Comprehensive Cancer Center
More Information
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03014804 History of Changes
Other Study ID Numbers: 16-001706 NCI-2016-01587 16-001706 P30CA016042
Study First Received: November 30, 2016
Last Updated: January 5, 2017
Health Authority: United States: Food and Drug Administration
Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Oligodendroglioma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
ClinicalTrials.gov processed this record on January 09, 2017
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For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CONTACT NLM HELP DESK
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U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
Jan 30th 8am
The bid and ask mean nothing before 8am, if no news hit and it's not actively trading.
I agree with everything you said(especially the ASCO comment!). This stock is not going anywhere until they clear the air on the PH3. I just wanted to figure out why Bloomberg was all of the sudden saying there are no shares held where I work. I checked with my compliance guy who files our 13F and he said it probably had to do with the move to the OTC. Then I pulled that document as verification.
As far as I am aware, now any institution can acquire shares and not have to report it until they get to 5% of the class outstanding, then 13D kicks in.
To answer my own commentary from the previous post:
See page 337 or Ctrl+F Northwest Bio. NWBO no longer needs to be reported via 13F filings since it moved OTC. Status: "DELETED"
SEC 13F Securities Q4 2016
No, you're confusing L and Direct. The Direct trial has not changed on clinicaltrials.gov since the last changed date of October 2015. Click History of Changes and then go into the Archive.
That is -Direct not -L. That was changed a long time ago.
That's the one that was on FB
Bloomberg has Institutional Ownership:
ARGS at 68.88%
NWBO at 44.53%
However, Bloomberg doesn't think I own the shares I own. It has the company I work at listed as 0 now, which is just not true. So, the best way, like you say, is look at multiple sources. I thought I'd provide the above as another source.
Yeah I don't know why they would write it like that. RK says a "^" is missing.
Good so we are in agreement
You sure love to refer back to those "patients" a lot. Weird
I will be moderately upset if we don't hear something concrete by the end of the month. I am getting tired of this.
How can anybody say that the current PH3 is in trouble when the brand new trial with Opdivo (NCT03014804) is comparing the following?
GROUP I: Patients receive DCVax-L intradermally (ID) on days 0, 7, 14, and weeks 4, 6, 8, 11, 14, 17 and 20.
GROUP II: Patients receive DCVax-L as in Group I, and Opdivo intravenously (IV) over 30 minutes on days 0, 14, and weeks 4, 6, 8, 11, 14, 17, and 20.
Why can this not be comprehended by so many?
Less than 10% of UK adults know that brain tumours kill more children & adults under the age of 40 than any other cancer. pic.twitter.com/GA9jQsu4hh
— Brain Tumour Research (@braintumourrsch) January 19, 2017
Did you know that brain tumours kill more women under the age of 35 than breast cancer. Help us make a difference: https://t.co/XFg5GQ2WsB pic.twitter.com/6axdec7qNN
— Brain Tumour Research (@braintumourrsch) January 15, 2017
They have a severe case of confirmation bias, but to them, only we do.
I read it yesterday, it's nothing. I can't post it. It basically says the same thing the SA "article" says.
Dont' believe they filed what? You're replying to no post.
Same here I was out of work the 10th and 11th of January. I had a fever that whole week.
added, thx
New 8K
Item 7.01. Regulation FD Disclosure.
In response to a question received by Northwest Biotherapeutics, Inc. (the
“Company”) from a shareholder relating to the status of the Company’s Phase
III clinical trials, the Company provided the response set forth in Exhibit
99.1 hereto.
The information in this Item 7.01, including the exhibit attached hereto, is
furnished solely pursuant to Item 7.01 of Form 8-K. Consequently, such
information is not deemed "filed" for the purposes of Section 18 of the
Securities Exchange Act of 1934, or otherwise subject to the liabilities of
that section. Further, the information in this Item 7.01, including the
exhibit, shall not be deemed to be incorporated by reference into the filings
of the registrant under the Securities Act of 1933.
EXHIBIT 99.1
Question from Shareholder:
1-19-17
Hi Les,
I have been a shareholder for the past year and eagerly awaiting the data for the Ph3 trials.
In the Dec 8 press release, it is mentioned that there will be an update in two weeks. Can you please let me know if there is a tentative date by which we would get an update?
Thanks
Response from the Company:
Dear XXXXXXXXX,
The further trial update includes information which comes from the independent CRO and independent imaging company on a blinded basis. We received some but not all of this information before activity shut down for the holidays. Unfortunately, we were not able to wrap up right after the holidays as key management involved in the process was out with a major case of the flu for several weeks, from New Year’s until late last week. Our team is now getting back into operation. We will be working on the further trial update this week, and hope to be ready with an announcement soon.
Thanks so much for your continued interest and concern.
Common sense has no place here, Xena
Wrong. Former CIA and FBI are involved now.
I concur, I just usually keep it to myself.
$8 Billion is being shaved from their market cap this morning versus yesterday's close.
8k:
Item 8.01. Other Events.
As previously reported by the Company, the Company’s voluntary withdrawal from listing on Nasdaq constituted a “Fundamental Change” pursuant to the indenture
(“Indenture”) relating to the Company’s Convertible Senior Notes (the “Notes”) that were issued in August, 2014 and are otherwise due in August, 2017. The Company was obligated to make an offer to repurchase the Notes in accordance with the terms of the Indenture within a period of 20 business days following this change. Accordingly, the Company was obligated to deliver the offer by January 19, 2017. If the Company’s offer is accepted, the Company will be obligated to execute the repurchase of the Notes by March 10, 2017. However, the Company is in active negotiations with interested third parties and the Holder of the Notes relating to a potential negotiated resolution in lieu of the Company repurchasing the Notes pursuant to the Indenture provisions.
In accordance with the Indenture, on January 19, 2017, the Company delivered a fundamental change notice (the “Notice”) to theHolder of the Notes. The Notice indicates that the Company is offering to repurchase the Notes at a fundamental change repurchase price (the “Fundamental Change Repurchase
Price”) equal to 100% of the principal amount of the Notes, plus any accrued and unpaid interest on the Notes up to, but not including, March 10, 2017 (the “Fundamental Change Repurchase Offer”). The full amount of interest for the full term of the Notes was escrowed at the time the Notes were entered into, and the funds for all interest amounts not yet paid remain in escrow.
The Notice also indicated that: (i) the Company ceased to be quoted on the Nasdaq Stock Market, which constituted a Fundamental Change and Make-Whole Fundamental Change under the Indenture, effective as of the open of trading on December 19, 2016; (ii) the anticipated fundamental change repurchase date for the Fundamental Change Repurchase Offer is March 10, 2017; (ii) the Paying Agent and Conversion Agent for the Notes is The Bank of New York Mellon, whose address is 101 Barclay St – 7W, New York NY 10286; (iii) the holder of the Notes must validly surrender the Notes and deliver a Fundamental Change Repurchase Notice to the Paying Agent Prior to 5:00 p.m. on March 9, 2017 in order to participate in the Fundamental Change Repurchase Offer; (iv) the holder may withdraw any valid submission of Notes by delivering to the Paying Agent, prior to 5:00 p.m. (New York City time) on March 9, 2017, a written notice of withdrawal specifying (a) the certificate number, if any, of the Notes in respect of which such notice of withdrawal is being submitted, (b) the principal amount of the Notes in respect of which such notice of withdrawal is being submitted and (c) the principal amount of the Notes which still remain subject to the original Fundamental Change Repurchase Notice; and
(v) that the holder will retain its conversion rights with respect to the Notes but must withdraw any its request to have the Notes repurchased before it may convert. The current Conversion Rate for the Securities is 151.4142 shares of Company common stock per $1,000 principal amount of Notes.
The Company is in active discussions with the Holder and third parties concerning a possible mutually agreeable negotiated transaction in lieu of the Company repurchasing the Notes at the Fundamental Change Repurchase Price.
However, at the current time, no definitive agreement with respect to an alternative transaction is yet in place, and there can be no assurance that such negotiations will be successful. In addition, there can be no assurance that, if an alternative resolution is not reached, the Company will be able to repurchase the Notes in accordance with the Notice by March 10, 2017.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
NORTHWEST BIOTHERAPEUTICS, INC.
Date: January 19, 2017 By: /s/ Linda Powers
Name: Linda Powers
Title: Chief Executive Officer and Chairman
I follow, thanks
Where are you getting this from? The last update I see on pacermonitor is:
"For those reasons, the Parties jointly support a continuation of the stay for an additional 60 days, until March 17, 2017."
Good stuff, sguesaldi