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Re: SkyLimit2022 post# 544135

Monday, 12/05/2022 8:07:46 PM

Monday, December 05, 2022 8:07:46 PM

Post# of 700220
ah. I must be wrong, fda would never allow a non crossover trial, OOOOOPs

Brief Summary:
The main purpose of this study is to determine whether adding SurVaxM to standard-of-care temozolomide chemotherapy is better than temozolomide treatment alone for patients with newly diagnosed glioblastoma. This study is designed to compare the length of survival in patients with newly diagnosed glioblastoma who receive temozolomide plus SurVaxM to that of patients treated with standard-of-care temozolomide plus placebo. This study aims to discover what effects, both good and bad, this combination of drugs may have on you and to see if the study drug (SurVaxM) can create an immune response in your blood that is directed against your cancer cells. This study also aims to determine whether treatment with SurVaxM plus temozolomide improves the survival of glioblastoma patients like yourself compared to treatment with temozolomide alone.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma Biological: SurVaxM Phase 2


CLINICAL TRIALS: IMMUNOTHERAPY| OCTOBER 01 2019
A Randomized Double-Blind Placebo-Controlled Phase II Trial of Dendritic Cell Vaccine ICT-107 in Newly Diagnosed Patients with Glioblastoma
Patrick Y. Wen;

David A. Reardon;

Terri S. Armstrong;

Surasak Phuphanich;

Robert D. Aiken;

Joseph C. Landolfi;

William T. Curry

;

Jay-Jiguang Zhu

;

Michael Glantz;

David M. Peereboom

;

James M. Markert;

Renato LaRocca;

Donald M. O'Rourke;

Karen Fink;

Lyndon Kim;

Michael Gruber;

Glenn J. Lesser;

Edward Pan

;

Santosh Kesari;

Alona Muzikansky;

Clemencia Pinilla;

Radleigh G. Santos;

John S. Yu

Author & Article Information
Clin Cancer Res (2019) 25 (19): 5799–5807.


Cancer

Original Article
Free Access
NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma
Eudocia Q. Lee MD,Peixin Zhang PhD,Patrick Y. Wen MD,Elizabeth R. Gerstner MD,David A. Reardon MD,Kenneth D. Aldape MD,John F. deGroot MD,Edward Pan MD … See all authors
First published: 10 March 2020

https://doi.org/10.1002/cncr.32811
Citations: 12
We thank the NRG staff, particularly Minhee Won, Suzanne Baldwin, and Kathryn Okrent, for their help with the study.
ClinicalTrials.gov identifier: NCT01609790.
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