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New Immunotherapy Trial

Printed From: TNBC Foundation
Category: TNBC Forums
Forum Name: TNBC Metastasis/Recurrence Users
Forum Description: A place to discuss metastatic disease
URL: http://forum.tnbcfoundation.org/forum_posts.asp?TID=13642
Printed Date: Aug 01 2021 at 5:39am
Software Version: Web Wiz Forums 12.01 - http://www.webwizforums.com


Topic: New Immunotherapy Trial
Posted By: sophie
Subject: New Immunotherapy Trial
Date Posted: Dec 10 2019 at 10:15pm
can we use this as preventive care? 



Replies:
Posted By: Ditrona
Date Posted: Jan 07 2020 at 5:51pm
This is vert interesting! My sister in law has recurrence in her lymph nodes, right now she is on Olaparib, but this sounds like a good option after! 

Excited to hear more from you when there is more results:-)!


Posted By: Kellyless
Date Posted: Jan 08 2020 at 8:17am
@Fulltilt - why aren't you doing any larger studies on TNBC patients? It sounds amazing until we get to the Two patients number. Are you looking for patient #3, or have you geared up for a trial with real numbers? Do you have a compassionate use OK from the FDA for stage 4 patients? I'm just trying to understand how your study works. I guess I'm looking for details on what you are doing right now - what's your plan for treating tnbc patients? How many are you looking to treat and how qu ickly? Can they be anywhere, with the drug given by any oncologist? or does it have to be specifically one location? Is it only given with Carboplatin for TNBC? 

Where do you stand with the FDA for use with HIV patients? 

Lastly - I see you mention NASH in that release, are you treating any NASH patients? That would be super interesting, as there's NO drugs really to treat NASH. My sister in law was diagnosed last year at age 55, she was healthy prior so it's been a shock. 


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IDC, 2.2 cm, Stage IIb,lumpectomy 1/30/09 ACx4,Tx4 36 rads
6/1/16 Local recurrence same breast, same spot 1.8cm Carb.4x every 3 wks, Taxol 12x once wk. Dbl Mast. PCR!! Reconstruction fail, NED!


Posted By: Suebhs
Date Posted: Feb 07 2020 at 1:00pm
I had my last chemo treatment yesterday for stage 1 tnbc. I was very fortunate in that it was discovered early during a routine ultrasound mammogram My oncologist participates in research studies and he was telling me they're doing very promising things right now with immunetherapy. Prayers that this will be the answer and hope for so many 🙏🙏🙏


Posted By: James123
Date Posted: Feb 14 2020 at 4:38pm
Has anyone on this site participated in this clinical trial 


Posted By: James123
Date Posted: Feb 15 2020 at 12:17am
after reviewing the results I noticed the patient with Brain Mets benefited greatly from the treatment but what about her lung and liver Mets ?  Has the drug reduced those tumors like it has in the brain?


Posted By: James123
Date Posted: Feb 15 2020 at 3:28pm
and one final question to include in your update next week

Out of the 8 patients how many are getting the drug alone without the carboplatin and seeing good results and is this a FDA approved clinical trial 

Thank you


Posted By: 123Donna
Date Posted: Feb 15 2020 at 4:21pm
James123

I believe this is the clinical trial:

https://clinicaltrials.gov/ct2/show/NCT03838367" rel="nofollow - https://clinicaltrials.gov/ct2/show/NCT03838367

Brief Summary:

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naÔve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).


Detailed Description:

Phase Ib

Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5. This dose finding portion of study will follow a "3+3" designed to determine the maximum tolerated dose (MTD) of leronlimab (PRO 140) administered as subcutaneous injection in subjects with histologically confirmed mTNBC that express CCR5.

Phase II

Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will increase PFS in patients with CCR5 + mTNBC.

Study Design
Go to 

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022


-------------
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15



Posted By: James123
Date Posted: Feb 15 2020 at 4:41pm
I mean it is NIH APPROVED study


Posted By: James123
Date Posted: Feb 15 2020 at 4:44pm
correction is it NIH APPROVED


Posted By: James123
Date Posted: Feb 16 2020 at 9:58am
 Thank you for this information 

Itís very appreciated and the drug is helping these women and that is sooooooo wonderful 

Please keep us posted on this website

I know study location is California but hopefully it will be expanded to other areas of the Country as well

😊


Posted By: 123Donna
Date Posted: Feb 16 2020 at 12:12pm
https://clinicaltrials.gov/ct2/show/NCT03838367" rel="nofollow - https://clinicaltrials.gov/ct2/show/NCT03838367

Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC

Study Description

Brief Summary:

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naÔve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).


*******************


Contacts
Contact: Kush Dhody, MBBS, MS, CCRA 301-956-2536 mailto:kushd%40amarexcro.com?subject=NCT03838367,%20CD07_TNBC,%20Leronlimab%20%28PRO%20140%29%20Combined%20With%20Carboplatin%20in%20Patients%20With%20CCR5+%20mTNBC" rel="nofollow - kushd@amarexcro.com

Locations
United States, California
Pacific Hematology Oncology Associates / Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Contact: David Ruiz    415-417-3337    mailto:david%40PHOAMD.COM?subject=NCT03838367,%20CD07_TNBC,%20Leronlimab%20%28PRO%20140%29%20Combined%20With%20Carboplatin%20in%20Patients%20With%20CCR5+%20mTNBC" rel="nofollow - david@PHOAMD.COM   
Contact: Mary Gascon    415-923-3105    mailto:mgascon%40phoamd.com?subject=NCT03838367,%20CD07_TNBC,%20Leronlimab%20%28PRO%20140%29%20Combined%20With%20Carboplatin%20in%20Patients%20With%20CCR5+%20mTNBC" rel="nofollow - mgascon@phoamd.com   
Sub-Investigator: Milana Dolezal, MD         
United States, Illinois
CD07 Investigational Site Not yet recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
CytoDyn, Inc.
Amarex Clinical Research



-------------
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15



Posted By: James123
Date Posted: Feb 21 2020 at 2:31pm
This is wonderful news!! Itís Amazing 😉 


Posted By: Ditrona
Date Posted: Feb 25 2020 at 9:20am
My sister in law is now going to participate in this trial. We got results today that she is both CCR5+ and PD-L1 positive. Hopefully she can combine both drugs (Keytruda + Leronlimab) with Carboplatin? 

She has recurrence only to her lymph nodes so far. The dream would be that this combo could eliminate it all, but weíll take all the extra time we get..

Iíll keep you posted on how things go!


Posted By: James123
Date Posted: Mar 26 2020 at 6:08pm
Has there been anymore news on this Trial and how the patients are doing.

Can you give us an update 


Posted By: Ditrona
Date Posted: Apr 01 2020 at 6:12am
An update on my sister in law:

She entered the program in the beginning of March. She has not done any tests after this due to the corona situation, however, she is not feeling very well, bad cough and lots of pain in her body, so she is feeling pretty sure the cancer has spread all over..She will take a new CT after Easter.


Posted By: James123
Date Posted: Apr 01 2020 at 8:14am
Did she get any of the drug administered at all?





Posted By: Ditrona
Date Posted: Apr 01 2020 at 10:26am
Yes, she was in California and got her first injection in early March. She then started on Carboplatin when she got back home. She has just been on Carboplatin for two weeks, but during these last few weeks, her condition has gotten worse. I just talked to my brother and they are taking her in to the hospital tomorrow, hopefully give her some stronger meds for her pain. 


Posted By: James123
Date Posted: Apr 03 2020 at 9:56am
This is wonderful News on this very exciting trial


Posted By: Mariote
Date Posted: Apr 16 2020 at 10:48pm
@Ditrona.
Oh, so your sister-in-law only got 1 injection of Leronlimab? May I ask the reason, if I am not being indiscreet? She couldn't get more because she was too weak/sick? Thanks in advance and hope your sister-in-law gets better.


Posted By: Ditrona
Date Posted: Apr 17 2020 at 12:18pm
Hm, not sure how many injections she took. She took the first in the U.S., and as she is a nurse, she is able to do self-injections, so she probably took some back home as well. However, she stopped after 1 month as she was getting worse. She had a new CT, and her tumors in her lymph nodes had grown. She is now on chemo + Tecentriq, as she is PD-L1 positive. Starting to feel better:-)


Posted By: Mariote
Date Posted: Apr 17 2020 at 6:58pm
Originally posted by Ditrona Ditrona wrote:

Hm, not sure how many injections she took. She took the first in the U.S., and as she is a nurse, she is able to do self-injections, so she probably took some back home as well. However, she stopped after 1 month as she was getting worse. She had a new CT, and her tumors in her lymph nodes had grown. She is now on chemo + Tecentriq, as she is PD-L1 positive. Starting to feel better:-)

Hi Ditrona, thanks for your kind answer. There's a trial that I understand is recruiting, using a KRAS inhibitor (AMG-510) alongside Keytruda. I've heard only good things about AMG-510 and we are waiting with hope for further developments in this field.

https://www.clinicaltrials.gov/ct2/show/NCT03310957" rel="nofollow - https://www.clinicaltrials.gov/ct2/show/NCT03310957


Posted By: Lulabelle39
Date Posted: Aug 14 2020 at 12:42pm
Iíd be really interested for an update on this trial, currently on nab-paclitaxel and atezolizumab for mTNBC in the uk and want this as my next treatment option if needed? This seems to be amazing although I can see itís only for treatment naive in the mets setting and US based praying the open this up to the uk and as a secondary!!!!



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