CLINICAL TRIALS and Important Links

Please feel free to read, share your thoughts, your stories and connect with others!
User avatar
Posts: 2443
Joined: Fri Aug 24, 2012 8:00 am

NCT02834052 Pembro (Keytruda) + Hiltonol

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

"Pembrolizumab + Poly-ICLC in MRP Colon Cancer"

(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:
Activating the Natural Host Defense
Hiltonol (Poly-ICLC)

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

Re: CLINICAL TRIALS and Important Links

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

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

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

Re: CLINICAL TRIALS and Important Links

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

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)

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. ... 20xOHl1U2M

User avatar
Posts: 9784
Joined: Sun Feb 10, 2008 6:00 pm


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
also accessible through its introduction page at

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

Trial finder:
My personal blog on the trial finder: https://adventuresinlivingterminallyopt ... al-finder/
Fight CRC's Press Release: ... -released/

User avatar
Posts: 9784
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 4
Stage IV A rectal cancer/lung met
12 Year survivor
my life is an ongoing totally randomized UNcontrolled experiment with N=1 !
Review of my Journey so far

User avatar
Posts: 1
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 ... 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.

Posts: 553
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

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; BRAF V600E
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
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
11/18- Beacon trial-encorafenib & cetuximab

User avatar
Posts: 9784
Joined: Sun Feb 10, 2008 6:00 pm

Keytruda and Vidaza combination trial

Postby CRguy » Sun Dec 10, 2017 12:59 pm

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.

Posts: 74
Joined: Thu Apr 19, 2018 5:59 pm

Re: CLINICAL TRIALS and Important Links

Postby Capri » Sat Apr 21, 2018 8:41 am

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!
Mom to son 46 yo at Dx (2017)
11/17 colonoscopy sigmoid tumor; CT & MRI chest, abd,& pelvis clear; CEA normal
1/18 Robotic resection, Path: adenocarcinoma, Stg. IIIA T3 N1 MX, mod. differentiated, margins clear
2/18 Port placed; 2/26/18 Begins FOLFOX
6/18 On Early surveillance CT 2 liver hemangiomas, PET scan-nothing "lit up"
Neuropathy has started.
7/30/18 Completed 12 cycles of FOLFOX.
Port removed October
11/2/18 Clean colonoscopy; 11/20 CT normal.
3/2019 Abdominal CT normal

User avatar
Posts: 9784
Joined: Sun Feb 10, 2008 6:00 pm

Re: CLINICAL TRIALS and Important Links

Postby CRguy » Wed Jan 16, 2019 5:59 pm

User avatar
Posts: 9784
Joined: Sun Feb 10, 2008 6:00 pm

Re: CLINICAL TRIALS and Important Links

Postby CRguy » Fri Feb 15, 2019 12:20 am

Looking for patients with advanced colorectal cancer to a test two different treatment combinations ... dium=email

This phase 3 trial is examining the effectiveness of arfolitixorin versus leucovorin (folinic acid) when added to a combined treatment with 5-fluorouracil, oxaliplatin, and bevacizumab (FOB) to treat advanced colorectal cancer. The main outcome to be measured is the cancer response to the treatment.

User avatar
Posts: 2
Joined: Thu Feb 21, 2019 4:30 am

Re: CLINICAL TRIALS and Important Links

Postby DawnS » Thu Feb 21, 2019 4:35 am

Great topic, thanks!
Nothing is impossible! International surrogacy made me a mother!

Return to “Colon Talk - Colon cancer (colorectal cancer) support forum”

Who is online

Users browsing this forum: boxhill, margiej, texmexflute and 32 guests