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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 4:21pm
James123

I believe this is the clinical trial:


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 naïve 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
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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

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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 4:41pm
I mean it is NIH APPROVED study
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 4:44pm
correction is it NIH APPROVED
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2020 at 9:28am
James I believe three of the first four patients are mTNBC and receiving Carboplatin along with Leronlimab in this trial. I do know that patient #2 is receiving only Leronlimab. Her last radiation treatment was last summer and they canceled her next scheduled radiation treatment because she was progressing so well in this trial. Here is the quote form the press release about her:

"Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patient’s radiologist cancelled 2nd round of treatment due to leronlimab’s effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has, and continues to be, the only treatment in place since the measurement of brain tumor shrinkage was initiated. Patient was permitted to obtain CTC+EMT test results. After 10 weeks of treatment with leronlimab, this patient’s CTC+EMT results were zero (results reported on 2/12/2020)."

When I go to NIH.gov and search the trial number NCT03838367 the trial with Leronlimab comes up. 


As far as I know this trial has not received a NIH grant. Here is the link to the trial at ClinicalTrials.gov:

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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2020 at 9:58am
 Thank you for this information 

It’s 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

😊
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2020 at 12:12pm

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 naïve 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 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    david@PHOAMD.COM   
Contact: Mary Gascon    415-923-3105    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

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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 21 2020 at 2:19pm
More incredible results! Amazing how fast this is all developing.

VANCOUVER, Washington, Feb. 21, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it has received Institutional Review Board (IRB) approval to begin its Phase 2 clinical trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated, “We currently have more than 70 patients eagerly waiting to participate in this basket trial and expect the first patient injection to take place within approximately ten days. Furthermore, overall enrollment of the trial could be completed in as little as 30 to 60 days, as this is a 30-patient trial.”

This basket trial is a 30 patient, CCR5+ Phase 2 study with locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Patients participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.

The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial treatment with leronlimab. The primary endpoint of the basket trial is progression-free survival.

“Peripheral blood sampling from Patient #1 in the mTNBC trial, who has been on leronlimab for approximately five months, revealed no cancer cells or cancer associated cells (0 CTC, 0 EMT and 0 CAML). In addition, Patient #2, who has been on leronlimab for almost 3 months in the MBC study, with brain metastasis, continues to show in the latest CT scan, stable lesions that are now described as scar-like suggesting repair in the metastatic tumors,” added Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “These data are substantiating the relationship between CCR5 and immune cell infiltrates and response which supports the current basket trial.”

“Our current basket trial focuses on method of action (MOA) rather than a specific cancer type,” continued Dr. Pourhassan. “We are extremely pleased the central IRB provided approval to proceed with the trial in a matter of weeks. This process can often take two months or more. If leronlimab proves to be as effective in this basket trial, as we have seen in our mTNBC and MBC patients, this opens up a strong potential for CytoDyn to file for another Breakthrough Therapy designation (BTD) for the 22 cancer indications being evaluated in this trial.”

About Basket Trials
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.1


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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 21 2020 at 2:31pm
This is wonderful news!! It’s Amazing 😉 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post 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 we’ll take all the extra time we get..

I’ll keep you posted on how things go!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 25 2020 at 11:45am
Awesome! I will pray that everything works well with her with both treatments. I suspect this should be a great combination.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post 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 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post 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.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Apr 01 2020 at 8:14am
Did she get any of the drug administered at all?



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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post 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. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Apr 01 2020 at 12:46pm
I hope the company will have trial data released later this week. I will update you all when we get news.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Apr 03 2020 at 9:29am
 https://www.cytodyn.com/newsroom/press-releases/detail/407/cytodyn-files-request-with-fda-for-preliminary-meeting-for

The Company’s pursuit of a Breakthrough Therapy designation is further strengthened by continued strong clinical indications from mTNBC and MBC patient data

VANCOUVER, Washington, April 03, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has filed a request with the U.S. Food and Drug Administration (FDA) for a preliminary meeting to discuss new clinical data which the Company believes further supports its objective to obtain Breakthrough Therapy designation (BTD) for leronlimab in the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC. Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request. Concurrent with the Company’s Phase 1b/2 trial for mTNBC and expanded access studies for MBC, it is also conducting a Phase 2 trial with leronlimab for 22 solid cancer tumors.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. 

The Company’s Phase 1b/2 study involves monitoring of circulating tumor cells (CTC), epithelial mesenchymal transition in tumor metastasis (EMT), and cancer-associated microphages like cells (CAML) every 21 days during the treatment phase.

Nader Pourhassan, Ph.D., President and Chief Executive officer of CytoDyn, commented, “We are extremely encouraged by the test results from these patients and continue to keep the FDA current on therapeutic benefit demonstrated by leronlimab for multiple cancer indications.”

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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Apr 03 2020 at 9:56am
This is wonderful News on this very exciting trial
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Mariote Quote  Post ReplyReply Direct Link To This Post 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.


Edited by Mariote - Apr 16 2020 at 10:51pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Apr 17 2020 at 8:13am

CytoDyn’s Phase 2 Basket Trial for 22 Solid Cancer Tumors Treats First Patient with Leronlimab; Patient Enrollment Delayed Due to COVID-19

VANCOUVER, Washington, April 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has treated the first patient in its Phase 2 basket trial for 22 solid cancer tumors. The patient has breast cancer, not triple-negative breast cancer.

This Phase 2 basket trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications, will include 30 patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Subjects participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.

The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial injection of leronlimab. The primary endpoint of the basket trial is progression-free survival.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn, commented, “The results so far in triple-negative breast cancer and HER-2+ breast cancer patients have remarkably demonstrated the shrinking of primary tumors, the shrinking or elimination of metastatic lesions, and the reduction of circulating tumor cells (CTCs) to zero, which has remained stable over several weeks. In other studies, we have seen CTC levels in this cancer >5 and some as high as 20 per 4 mL of blood. Further, these data help define the relationship between CCR5 on immune cell infiltrates and response as we analyze these responding patients. Based on histologic findings in other cancers, we are hopeful that this response translates to the other tumors in this trial.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, concluded, “We are excited to treat our first patient in this basket trial and are optimistic indications will reflect results in our other metastatic breast cancer trials, all of which will be presented to the FDA in our upcoming preliminary Breakthrough Therapy designation meeting.”

About Basket Trials
A Basket Trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.

About Leronlimab (PRO 140) 
The FDA has granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. 

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.



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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post 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:-)
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