CLINICAL TRIALS and Important Links

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Maia
Posts: 2443
Joined: Fri Aug 24, 2012 8:00 am

NCT02834052 Pembro (Keytruda) + Hiltonol

Postby Maia » Sat Nov 12, 2016 4:41 pm

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

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Re: CLINICAL TRIALS and Important Links

Postby Maia » Wed Dec 28, 2016 4:25 pm

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

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Re: CLINICAL TRIALS and Important Links

Postby Maia » Wed Dec 28, 2016 8:03 pm

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

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CRguy
Posts: 9286
Joined: Sun Feb 10, 2008 6:00 pm

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

Postby CRguy » Wed Jan 04, 2017 6:11 pm

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.

Image

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/

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CRguy
Posts: 9286
Joined: Sun Feb 10, 2008 6:00 pm

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

Postby CRguy » Mon Jan 16, 2017 8:35 pm

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 !
Caregiver x 3
Stage IV A rectal cancer/lung met
10 Year survivor
my life is an ongoing totally randomized UNcontrolled experiment with N=1 !
Review of my Journey so far

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mariobryant
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Joined: Thu Mar 16, 2017 6:07 am
Facebook Username: mariobryant

Re: CLINICAL TRIALS and Important Links

Postby mariobryant » Sun Mar 19, 2017 5:58 am

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.

Steph20021
Posts: 492
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

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

Postby Steph20021 » Thu May 11, 2017 4:33 pm

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
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, hysterectomy et al, 2nd temp ileo, NED?
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
Jan/17- pulmonary embolism
Feb/17- 1 wk radiation to abdo wall
Currently stable suce Aug/16- on folfiri


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