Replies to post #93937 on NorthWest Biotherapeutics Inc (NWBO)

[john1045]

Nice find TC! This is very encouraging news! Do we get a PR on this soon is the question? With BMS aligned in this trial is very telling to me they see benefit of this approach with DCVax. I like this also has National Cancer Institute as Sponsor and Collaborator as well.

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

New DCVax Clinical Trial with Opdivo is on clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT03014804?term=dcvax&rank=7

[Virgilio]

Though it is indeed a nice find, I am very surprised no PR has been issued so far, or did I just miss it?

[Astavakra]

Interesting:

Dendritic Cell-Autologous Lung Tumor Vaccine and Nivolumab in Treating Patients With Recurrent Glioblastoma

[Milner1]

after the dust settles linda powers will give all u longs a .005 in bk. imo

[eagle8]

Thanks TC.

Great news.

GLTU

[H2R]

Great find TC! Thanks for sharing!

[Evaluate]

ClinicalTrials.gov Identifier: NCT03014804
First received: November 30, 2016

If this trial info was first submitted to CT.gov at end November .... I wonder when NWBO is planning on putting out a PR about it?

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# of Primary Outcome Measures = 2
# of Secondary Outcome Measures = 11 (including PFS and including Quality of Life)
# of Other Outcome Measures = 20

... Lots of measurements!


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Estimated Enrollment: 30
Study Start Date: April 2017
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

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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.

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.

Treatment schedule looks identical between Arm 1 & Arm 2 ... with the exception of Arm 2 does not include a treatment on Day 7? Perhaps a typo?

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Biological: Dendritic Cell-Autologous Lung Tumor Vaccine
Given ID
Other Name: DCVax-Lung

I thought DCVax-L was essentially an abbreviation for Dendritic Cell Vaccine - Lysate .... but now DCVax-L is to be recognized as DCVax-Lung?

[H2R]

I emailed Dr. Cloughesy, LL, and LG to let them know about the mislabeling and hopefully bring about a correction.

Thanks again TC!

[H2R]

I really like L + PD-1 in the combo trial

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

This looks like a key trial in I/O! It could have a chance of becoming the SOC, especially if safety is as good as with L.

[sbnyc]

FYI all (and for Flippers calendar) the combo trial of DCVAX and Nivolumab seems to now have a start date of Oct 1, 2017. It was Aug 1, 2017.
(See replied-to msg for link)
$BNYC

[Ultraz2]

I believe they should add, no diabetes in eligibility criteria...it confounds the data...giving steroids, even at low doses, which increase glucose to feed tumor growth and which lower immune response...my sister’s cancer progressed so rapidly on Keytruda with glucose consistently in the 400s while on steroids...it seems so counter productive.

[Ultraz2]

Is this new...I see updated in October 2017 and posted in Jan 2017...but, encouraging is PFS is a secondary endpoint...this is why I believe the trial failed PFS and all the silent treatment...so they are betting on OS IMHO.