New Keytruda clinical trial announced - a potentially great new immunotherapy

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Tall Allen
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Date Joined Jul 2012
Total Posts : 8787
   Posted 8/10/2016 11:36 AM (GMT -7)   
Next month, recruiting will begin for a great clinical trial for Keytruda (pembrolizumab), the anti-PD-1 immunotherapy. It’s already approved for melanoma, lung cancer, and head-and-neck cancer. Some of you may remember that this is the drug that Jimmy Carter attributes to his melanoma remission.

The really nice thing about this trial is that everyone gets Keytruda. This is only for patients with metastatic castration-resistant prostate cancer (mCRPC). There are 3 cohorts. Patients will get Keytruda with a different combination of medicines depending upon which medicines they’ve used before.

Cohort A (70 patients): Keytruda + Lynparza (olaparib)

Lynparza has demonstrated efficacy in men with certain genetic deficits that interfere with DNA repair (like mutations in the BRCA 1 and 2 genes). Patients must have already had Taxotere (docetaxel) therapy previously. Prior treatment with Zytiga, Xtandi or both is allowed.

Cohort B (70 patients): Keytruda + Taxotere (docetaxel)

This is for patients who have not yet received Taxotere infusions for metastatic PC. Eligible patients must have received prior Zytiga or Xtandi but not both. They must have good performance status.

Cohort C (70 patients): Keytruda + Xtandi (enzalutamide)

Patients must have received prior Zytiga, but not prior Xtandi. They may have received Taxotere for metastatic hormone-sensitive PC, but not for metastatic castration-resistant PC.

Other:
There does not appear to be any exclusion for prior use of Provenge or any other investigational immunotherapy taken at least 4 weeks prior to starting on the study.

Tumor tissue samples must be provided.

There are other exclusions due to certain co-morbidities, and recent use of other drugs. You can check the exclusion criteria in the following link:

/clinicaltrials.gov/ct2/show/NCT02861573

It’s scheduled to start in September, and I hope it will be in multiple locations. It has started recruiting in all locations. If you think you qualify, you may want to forward the link to your medical oncologist and begin discussions about it.

added recruitment update
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
SBRT 9 yr onc. resultsSBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.1,no lasting urinary, rectal or sexual SEs
my PC blog

Post Edited (Tall Allen) : 8/17/2017 4:42:31 PM (GMT-6)


RobertC
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Date Joined May 2011
Total Posts : 1297
   Posted 8/11/2016 4:14 AM (GMT -7)   
The recent first-line lung cancer trial of Keytruda that was successful required >.49 of tissue to contain PD-L1 marker.

Post Edited (RobertC) : 8/11/2016 12:30:37 PM (GMT-6)


Tall Allen
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Date Joined Jul 2012
Total Posts : 8787
   Posted 8/15/2016 12:42 PM (GMT -7)   
I just came across a related clinical trial at Peking University in Beijing, China (not that I expect anyone here will go there for it). They are using CRISPR technology to knock out the PD-1 gene from some extracted T-cells from metastatic castration-resistant PC patients. Then they will reinfuse the T-cells with the PD-1-deleted genes together with low-dose cyclophosphamide and IL-2 to enhance the immune response. It's the first time I've seen CRISPR used for prostate cancer in humans. If it works, it can continue to hunt and destroy cancer cells, perhaps indefinitely. If it doesn't work, it can cause a lethal runaway immune response. Should be interesting.

PD-1 Knockout Engineered T Cells for Castration Resistant Prostate Cancer

- Allen

Newton451
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Date Joined Feb 2016
Total Posts : 552
   Posted 8/15/2016 2:10 PM (GMT -7)   
Eeeeek.....the runaway immune response is scarey. I had a cold-type bug that my T cells likened to back muscle tissue cells. Scarey couple of days. Auto-Immune system corrected itself, but only after 2 days of gutwretching back spasms.
Age at DX 53
PSA 11/14=8, 11/15=11.5
DRE Nodule LHS LWR
22 Jan 2015, Biopsy 3 of 10 positive
3+3, 4+3, 4+4
Scans...NEG for METs
Triple Play Chosen (HT/HDRBT/EBRT)
Lupron Depot/Casodex 4 months base plan - Started 31st March
03/31/16 PSA=10.40, T=9.0
05/19/16 PSA=.64, T=<.6
HDRBRT 21/06/2016-16 Cath, 15Gy
EBRT started 05/07/2016-Tot 46 Gy, 23 Down...0 to go...DONE!
NTAF MY FRIENDS...EEEE

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8121
   Posted 8/15/2016 3:58 PM (GMT -7)   
We haven't seen enough back yet on pembro as it pertains to prostate cancer. But this is the right trial for it. They piggybacked some interesting arms and bio collection.
BioSketch tinyurl.com/mw36q72

Please note: While I work daily with the medical research teams on PCa, I am not a medical doctor. Please talk to your doctor before making decisions.

celebrate life
Veteran Member


Date Joined Dec 2014
Total Posts : 2076
   Posted 8/16/2016 9:59 AM (GMT -7)   
Any idea why prior radium therapy not allowed? I assume that would include xofigo and any RT. Or just the radium therapy for systematic bone mets?
Beth

Tall Allen
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Date Joined Jul 2012
Total Posts : 8787
   Posted 8/16/2016 10:13 AM (GMT -7)   
Beth-

It's only Xofigo that they exclude, not RT. I think maybe because it is systemic, and because only some patients would have had it, it may confound the consistency of the results (ie, those who have had it may do better (or worse) than others who haven't had it). I'd imagine too that, because it's systemic, it pours a lot of cancer antigens into circulation that may affect the immunotherapy response in an unpredictable way.

- Allen

BillyBob@388
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Date Joined Mar 2014
Total Posts : 2583
   Posted 8/16/2016 10:55 AM (GMT -7)   
May it work out wonderfully! Go get the rat bastids, immune cells!
PSA 10.9 ~112013
Bx on 112013 at age 64 yrs 11 months, with 5 of 12 pos with one G9(5+4), 1 PNI, T2B.
RALP with lymph nodes at Vanderbilt 021914. (nodes clear, SV+, still G9 but down graded to 4+5, cut wide, but 1 tiny foci right at the edge of margin ) Pros. 106.7 gms!
At 15 months, not wearing a pad most days, mostly dry
PSA <.01 on 6/11, 8/20/14 and 3/4/15, up to .01 on 9/1/15, .01 3/10/16

Tony Crispino
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Date Joined Dec 2006
Total Posts : 8121
   Posted 8/16/2016 12:16 PM (GMT -7)   
Beth,
Xofigo is excluded from many immunotherapy trials because it directly affects bone marrow. Bone marrow produces red and white blood cells and also platelets. But it's the white cells that get weakened that affects the bodies immune system. And that is largely regarded as a disqualifier for immuno-therapies.

This is also why Xofigo is not a good pre-chemotherapy combination. Chemo affects white blood cell counts and Xofigo inhibits their reproduction.

Post Edited (Tony Crispino) : 8/16/2016 1:33:08 PM (GMT-6)


Tall Allen
Veteran Member


Date Joined Jul 2012
Total Posts : 8787
   Posted 9/2/2016 5:53 PM (GMT -7)   
Still no update on the sites for the above clinical trial, but Merck did announce sites for a related trial of Keytruda.

This one gives Keytruda to men with metastatic castration-resistant PC (mCRPC) who have already had at least one cycle of chemo.

Patients will be assigned to 1 of 3 arms depending on whether their biopsy of a metastasis demonstrates the presence of PD-L1 and whether they are currently displaying measureable disease.

Other key requirements are:
• No more than 2 cycles of chemo
• At least one 2nd line hormone therapy (like Zytiga, Xtandi, etc.)

In the US, the sites are in Phoenix, New Orleans and Fargo (Whiskey Tango Foxtrot!!). There are 15 sites outside of the US

Here's the trial spec:

/clinicaltrials.gov/ct2/show/study/NCT02787005
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
SBRT 9 yr onc. resultsSBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.2,no lasting urinary, rectal or sexual SEs
my PC blog

Post Edited (Tall Allen) : 9/2/2016 6:56:03 PM (GMT-6)


Howard3569
Regular Member


Date Joined Nov 2014
Total Posts : 257
   Posted 9/3/2016 6:35 AM (GMT -7)   
This is great news for everyone.
Surgery Nov, 14 2014 Negative margins, negative lymph nodes, negative vessels
Gleason 3+7 PSA .08 Dec 14, 2004; <0.05 on March and July 2015; 0.05 on Oct 2015 and 0.07 on January 2016

Fairwind
Veteran Member


Date Joined Jul 2010
Total Posts : 3554
   Posted 7/25/2017 7:10 AM (GMT -7)   
Unfortunately, Kaytruda has not met expectations as a treatment with a potential for broad usage in treating many types of cancers. One of the trials had to be stopped when a large percentage of patients suffered adverse reactions to the drug and died. I spotted the article in Yahoo News this morning.....A big set-back for Merck
Age now 74 . Diagnosed G-9 6/2010
RALP Sept 3 2010, pos margin, one pos vesicle nodes neg. Post Op PSA 0.9 SRT, HT. 2-15-'11 PSA <0.1 10/'11, <0.1 2/12, <0.1, 4/12 <0.1, 9/12, 0.8 3/13, 0.5 6/13, 1.1, back on HT. 5/16 stay the course, Lupron, Zytiga, PSA <0.1 10/16 no change <0.1 5/17 PSA 1.6 Chemo or Provenge next..

RobLee
Regular Member


Date Joined Apr 2017
Total Posts : 386
   Posted 7/25/2017 7:52 AM (GMT -7)   
It seems that Keytruda is still considered effective for solid tumors. The halted trials appear to involve treatment of blood cancers, specifically multiple myeloma.
2014-15: PSA's 9, 12, 20, 25... Neg DRE, Neg TRUS biopsy
6/16: MRI Fusion biopsy, Rt Base, 2x40%+2x100% all G8 (4+4)
8/16: DaVinci RP, 6mm EPE, PNI, Grade 4, BL SVI, stage pT3B N0M0
1/17: start one year Lupron ADT, PSA's ~.03
5/17: AMS800 AUS implanted, revised 5/30
38 fractions IMRT SRT scheduled Aug-Oct 2017
Age 66, recently retired to Florida 'just in time'

Tall Allen
Veteran Member


Date Joined Jul 2012
Total Posts : 8787
   Posted 7/25/2017 10:36 AM (GMT -7)   
I notice that both of those Keytruda trials have expanded and are currently recruiting. The first one is at 9 sites in the US (+7 sites abroad), and the second one at 21 sites in the US (+17 sites abroad).
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
SBRT 9 yr onc. resultsSBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.1,no lasting urinary, rectal or sexual SEs
my PC blog

Fairwind
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Date Joined Jul 2010
Total Posts : 3554
   Posted 7/25/2017 5:23 PM (GMT -7)   

kukukajoo
Veteran Member


Date Joined May 2014
Total Posts : 619
   Posted 7/25/2017 5:47 PM (GMT -7)   
Is this recruiting?
Paul 2014 dx age 47:
PSA dx 115.07, now .33 with 4 rises
BX 5/8- 12/13 cores nearly 100% 3+4 & 4+4 PNI
CT abd/pelvis: 5/28-lymph
Bone scan 5/27- clear
CT Chest 5/29- innumerable mets both lungs
Bostwick adds 5% pattern 5
lymph mets neck, other
june Lupron added
7/3 Taxotere 1 infusion then GI & Cardiac issues
Bone, liver, lung, lymph
6/17- mets returning, castrate resistant

Tall Allen
Veteran Member


Date Joined Jul 2012
Total Posts : 8787
   Posted 7/25/2017 6:32 PM (GMT -7)   
All immune boosters and checkpoint inhibitors have the possibility of generating a runaway immune cascade and consequent death. That risk has to be weighed against the benefit of extending life. This is what clinical trials are for: (1) to assess safety (2) to find the optimal and safe dose and (3) to demonstrate efficacy. One always takes a risk in enrolling in a clinical trial, but the benefits include being closely watched and monitored over time, you will be treated with at least the standard of care, drugs you couldn't otherwise get are free, and, by participating, we benefit others who come after us.
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
SBRT 9 yr onc. resultsSBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.1,no lasting urinary, rectal or sexual SEs
my PC blog

cspivak
Regular Member


Date Joined Aug 2014
Total Posts : 200
   Posted 7/27/2017 7:52 AM (GMT -7)   
@Fairwind: the halted trials are for combo drug use - did I read that wrong? Can you link to the news item?

If I read the links you did post correctly, and there isn't more recent news, then your first 7/25 post is not accurate.

Post Edited (cspivak) : 7/27/2017 12:01:50 PM (GMT-6)


Tall Allen
Veteran Member


Date Joined Jul 2012
Total Posts : 8787
   Posted 8/17/2017 3:37 PM (GMT -7)   
I thought I'd bump this up with the mention of a new Keytruda clinical trial. This one is at UCSF is projected to begin in October. In this one, they will biopsy a metastasis to find 25 mCRPC men who have a DNA mismatch repair defect and 25 mCRPC men who have no DNA repair defects. They will get Keytruda and the option of chemotherapy. Patients must be chemo naive or sensitive and have received Zytiga or Xtandi. Keytruda is already approved for DNA mismatch repair defects.

/clinicaltrials.gov/ct2/show/NCT03248570
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
SBRT 9 yr onc. resultsSBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.1,no lasting urinary, rectal or sexual SEs
my PC blog

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8121
   Posted 8/18/2017 12:42 AM (GMT -7)   
Allen,
We have four trial concepts for phase III approaches for prembo at SWOG. ECOG and Alliance also have proposals pending. It will be n interesting race to the finish line. UCSF is both an Alliance and SWOG participant. I like the proposals for the Phase III's. But they are at least a couple years away.
BioSketch tinyurl.com/mw36q72

Advanced PCa Survivor (dx in 2006)
Patient Advocate at ASCO, SWOG, AUA
UsTOO Las Vegas Chapter Chairman

I am not a medical doctor.

Tall Allen
Veteran Member


Date Joined Jul 2012
Total Posts : 8787
   Posted 8/18/2017 8:45 AM (GMT -7)   
Tony-

The way I look at it, it's an opportunity for patients in various situations to get a potentially useful drug that they would not ordinarily be able to get and at no cost. I also like the personalized approach that some of these trials are taking.
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
SBRT 9 yr onc. resultsSBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.1,no lasting urinary, rectal or sexual SEs
my PC blog

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8121
   Posted 8/18/2017 10:29 AM (GMT -7)   
Agreed Allen,
These Phase II trials are a great opportunity. Take advantage if you can. PD1 and PD-L1 inhibitors have been successful in several cancers. I believe they will have some benefit in prostate cancer.

T
BioSketch tinyurl.com/mw36q72

Advanced PCa Survivor (dx in 2006)
Patient Advocate at ASCO, SWOG, AUA
UsTOO Las Vegas Chapter Chairman

I am not a medical doctor.

jannnett
Regular Member


Date Joined Jan 2015
Total Posts : 116
   Posted 9/17/2017 9:51 PM (GMT -7)   
I wish it proves promising and proves helpful for my father who has metastatic bone disease and PSA 27

NewDay
Regular Member


Date Joined Nov 2015
Total Posts : 104
   Posted 9/18/2017 1:28 PM (GMT -7)   
Sounds like, Immunotherapy has finally started to get some serious legs. We need to fight this crap at the core (cell) level from our own defenses. Cut, Burn and/or Poisoning requires the luck of the hit. It's time to change the game and have a real sustainable cure.
________________________________________________________________________

MAR 2017: PSA 2.3 (non-URO Lab)
NOV 2016: PSA 3.7, Biopsy (12) cores Benign/Negative
JUL 2016: Bone Scan (NEGATIVE)
JUN 2016: PSA 2.7 (non-URO lab)
APR 2016: PSA 3.7

OCTOBER 2015
Age: 59
PSA: 3.0 elevated to 3.5 in (6) months
3T-MRI: (1) lesion identified
Fusion Biopsy Results: Lesion cores benign, addtional (12) cores = (1)5%
Pathology Summary: Grade Group 1 (G6:3+3), 2nd pathology verification
Clinical Stage: T1c

Genetic DNA Profile: Above average risk for Aggressive PC (Genetics Test)
Existing Cancer DNA Profile: DNA risk unknown (Oncotype DX test cannot be performed, <1mm)
High Grade Biological Score: 27% aggressive risk (Mi-Prostate Score)
Other Health Conditions: Diabetes Type II (DX 2000), on meds & insulin

PCa Treatment: "Active Surveillance" + "Home Natural Cancer Treatment"
Risk: Undetected Cancer Progression
Risk Likelihood: LOW

My Story: http://www.healingwell.com/community/default.aspx?f=35&m=3528051

Fairwind
Veteran Member


Date Joined Jul 2010
Total Posts : 3554
   Posted 9/18/2017 2:58 PM (GMT -7)   
Where there is smoke there is fire...Looks like they might have some more work to do on Keytruda before they put it into more wider use....

www.genengnews.com/gen-news-highlights/after-deaths-fda-places-clinical-holds-on-keytruda-combo-trials/81254610
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