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NCT02834052 Pembro (Keytruda) + Hiltonol

Posted: Sat Nov 12, 2016 4:41 pm
by Maia
NCT02834052
"Pembrolizumab + Poly-ICLC in MRP Colon Cancer"

https://clinicaltrials.gov/ct2/show/NCT02834052

(That is: Pembrolizumab (Keytruda) + Poly-ICLC (Hiltonol; experimental viral mimic and broad activator of innate immunity) in MRP ( = MSS) Colon Cancer"

Not yet recruiting. Only at Georgia Cancer Center, at Augusta University

"Current clinical trials are showing that patients whose tumors are mismatch repair deficient (MSI) are more likely to respond to immune-boosting anti-PD-1 drugs—such as pembrolizumab—than those with tumors proficient in mismatch repair (MRP or MSS). The idea is that the greater the number of DNA glitches in a tumor cell, the more abnormal proteins it will produce—and the more abnormal proteins that are generated, the greater the odds that the body's immune cells will regard the tumor cells as "foreign" and target them for destruction. Thus far, PD-1 inhibitors have shown great promise for mismatch repair deficient cancer patients, but not for mismatch repair proficient (MRP) cancer patients.

In this clinical trial, the investigators hypothesize that treating MRP colon cancer patients with immunostimulating agent poly-ICLC will generate an inflammatory response, increasing epitope recognition and development of tumor reactive T-cells at the tumor site. However, interferon alpha and gamma produced by the poly-ICLC will increase PD-L1 expression and limit new T-cell development. Thus, PD1 blockade will increase the effectiveness of treatment with pembrolizumab."

Description of Poly-ICLC: http://adisinsight.springer.com/drugs/800001705
Activating the Natural Host Defense
Hiltonol (Poly-ICLC)
: http://www.oncovir.com/id2.html

Re: CLINICAL TRIALS and Important Links

Posted: Wed Dec 28, 2016 4:25 pm
by Maia
NCT02860546
A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC

An interesting trial, aimed exclusively to microsatellite stable CRC (the %85 of CRC). It combines TAS-102 (Lonsurf, oral, approved for mCRC) with nivolumab (Opdivo, anti PD-1 immunotherapy, approved for many other cancers; it would be an off-label use). (Not medical advice but the point is that the trial combination might be reproducible under the care of some oncologist who judges this worhty.)



*Only for MSS
*TAS-102 (Lonsurf) + nivolumab (Opdivo)
*Phase II. Non randomised.
*Does allow prior treatment with Lonsurf or any other checkpoint inhibitor
*Colorado, Florida, Tennessee

https://clinicaltrials.gov/ct2/show/NCT02860546

Re: CLINICAL TRIALS and Important Links

Posted: Wed Dec 28, 2016 8:03 pm
by Maia
NCT02991196
Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Advanced Colorectal Cancer

*Only mismatch repair (MMR)-proficient (=MSS) advanced colorectal cancer.
*Antibody DS-8273a + Nivolumab (=agonistic TRAIL-R antibody DS-8273a + anti-PD-1)
*DS-8273a: decrease in myeloid-derived suppressive cells (MDSC)
*Columbia and Texas; some locations still not recruiting
*a phase I trial in Solid tumours and Lymphoma (Late stage disease) completed 2015 (NCT02076451)

https://clinicaltrials.gov/ct2/show/NCT02991196

December 2, 2016: Selective targeting of myeloid-derived suppressor cells in cancer patients using DS-8273a, an agonistic TRAIL-R2 antibody J. Bendell et al. https://drive.google.com/open?id=0Bwc5k ... 20xOHl1U2M

A DK37 CURATED MSS-CRC CLINICAL TRIAL FINDER! >> UPDATED

Posted: Wed Jan 04, 2017 6:11 pm
by CRguy
Just a quick note to inform folks of yet another major posting by our resident "rock star" scientist !

DK37 has started his own topic A DK37 CURATED MSS-CRC CLINICAL TRIAL FINDER!
which links directly to the new web app http://colorectalmsstrials.org/
also accessible through its introduction page at http://bit.ly/2jaj7tc

with a little help from a couple of good friends, Maia and Jana !

Thank you once again for a job well done.



UPDATED INFO : as of May 16,2017
in this topic NEW DK37 AND MAIA MSS-CRC CLINICAL TRIAL FINDER!

Links:
Trial finder: http://trialfinder.fightcrc.org/
My personal blog on the trial finder: https://adventuresinlivingterminallyopt ... al-finder/
Fight CRC's Press Release: https://fightcolorectalcancer.org/blog/ ... -released/

Some New Links for info about Clinical Trails in Canada and around the globe !

Posted: Mon Jan 16, 2017 8:35 pm
by CRguy
I just updated the Calling ALL Colorectal CANUCKS ! topic with some recently discussed links from a Canadian senior's magazine
Some New Links for info about Clinical Trails in Canada and around the globe !

Re: CLINICAL TRIALS and Important Links

Posted: Sun Mar 19, 2017 5:58 am
by mariobryant
The purpose of this study https://www.mskcc.org/cancer-care/clini ... als/15-048 is to assess the safety of combining two drugs, varlilumab and nivolumab, in patients with advanced solid tumors that have continued to grow despite treatment. Varlilumab is an investigational drug that binds to a protein on immune cells called CD27, which makes the immune system stronger. Nivolumab is a form of immunotherapy. It works by attaching to and blocking a molecule called PD-1, which shuts down the immune response. It is hoped that by binding to these proteins, this drug combination can activate the immune system and enhance the body’s ability to detect and destroy cancer cells.

Re: NCT02888743 Durva (anti PD-L1) + Treme (anti-CTLA-4) + radiation

Posted: Thu May 11, 2017 4:33 pm
by Steph20021
My friend will likely be trying Tremelimumab with Durvalumab in Toronto under NCT02870920 but he has been told he has to do a targeted therapy first. Folfiri and Folfox have already failed him. I'll post any updates here that he has if and when he finally gets accepted into the trial -hopefully soon. I'm going to read up on Maia's links on the combo now.

Maia wrote:NCT02888743
Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer
https://clinicaltrials.gov/show/NCT02888743

Not yet recruiting. At Dana-Farber - Harvard Cancer Center. Boston, Massachusetts.

All 3 arms receive the 2 immuno drugs: A: two drugs without radiation; B: two drugs with radiation at a low dose; C: B: two drugs with radiation at a higher dose.
Lesion to be radiated has to be in liver.
Only for MSS

(Patients on the CRC arm need to have: "Microbiology Susceptibility Subcategory (MSS) tumor as documented by either:
Immunohistochemistry (IHC) testing that does not suggest loss of MLH-1, MSH-2, PMS2 or MSH6
Polymerase chain reaction (PCR) testing that does not suggest microsatellite instability (MSI))

durvalumab (MEDI4736): anti PD-L1, similar to atezolizumab.
tremelimumab: anti-CTLA-4, similar to ipilimumab.
More about the combination here: (May 2014) viewtopic.php?f=1&t=46727 and (Nov 2015) viewtopic.php?f=1&t=52938

Keytruda and Vidaza combination trial

Posted: Sun Dec 10, 2017 12:59 pm
by CRguy
Looking for participants with advanced lung or colorectal cancer to undergo a combined treatment with different targeted therapies
More info and site information is available at this link : colorectal cancer Clinical Trial

In a nutshell
This phase 1/2 trial aims to study the safety and effectiveness of the treatment with different targeted therapy in patients with advanced lung or colorectal cancer. The main outcome to be measured is the response rate of the tumor to the treatment and the negative side effects. This trial is recruiting in California, Illinois and Texas, United States.

How will it work
Patients will receive increasing doses, by injection, of azacitidine over days 1 and 7, pembrolizumab over 30 minutes every 3 weeks on day 1 and epacadostat tablets twice daily. Treatment will repeat until disease progression or unacceptable side effects. Participants will be followed for up to 18 months.

Re: CLINICAL TRIALS and Important Links

Posted: Sat Apr 21, 2018 8:41 am
by Capri
As a caregiver and new to this site, I want to thank all the posters for this valuable information, how-tos and links. Very important and so helpful!