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    In reply to: 3rd line treatment?


    Dear community, I hope everyone is hanging in there.

    Thank you so much Mary and Positivity for your kind and helpful replies last time. I’m sorry it took me so long to reply – I’m always so overwhelmed! I wanted to update you on what we ended up doing:

    – On 6/25/18, my dad entered an immunotherapy trial at the NIH pairing 2 checkpoint inhibitors with ablation.

    He has had 2 infusions so far of anti-PD-L1 (durvalumab) and anti-CTLA4 (tremelimumab).

    On 8/2/18, he had radiofrequency ablation to 2 small new perihepatic lesions. The hope is that the neoantigens released by the ablation will help the primed immune system recognize the cancer and create an abscopal effect (getting rid of all the cancer!)

    He recovered well from the ablation and just a week later was exercising again (he has also gained some of his energy back from not being on chemo since his last folfiri May 8th.)

    – On 8/11 (this past Saturday), he woke up with a fever and feeling super fatigued. By evening temp was 100.4 so the on-call NIH doctor told him to go to the ER. They ran labs, ekg, scan – could find no infection or reason for the fever, so they sent him home at 3am.

    – on Sunday, he still had the fever and fatigue – and then a rash developed! It was maculopapular, all over his chest and back and his face was red, and then appeared on his legs and arms by the next day. It does not itch. The NIH told him to use a corticosteroid cream.

    By today (8/15), temp is normal for the past 15 hours and the rash seems to be slooowly fading a bit.

    We did a biopsy and it came back as “Superficial perivascular lymphcytic rash (no vasculitis, no interface dermatitis, and paucity of eosinophils.)”

    I assume it’s the classic immunotherapy rash I have read about. But if it was an immune-mediated reaction, would that mean eosinophils should have been found?

    I hope it means the immunotherapy is working!

    I’m concerned about the low fever for several days and extreme fatigue. (I’m also concerned that a potentially immune-mediated reaction this early could mean more immunotherapy adverse affects later on?)

    If anyone has any experience or info to share, would be so grateful. Thank you!
    My warmest wishes to all,


    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer



    Hello everyone.

    Although this is my first time posting, I’ve been reading multiple entries on this site for information, solace, and hope.

    My 35 year old wife was diagnosed month ago with stage 4 intrahepatic cholangiocarcinoma. She was excited to begin her second in law school when she went to see a doctor for a cramp in her right abdomen. She initially thought it could be an appendicitis, and when her doctor ordered ultrasound and referred her to a larger hospital, the most horrific month of our lives began to unfold.

    After a series of CT, PET, MRI scans and a needle biopsy, they confirmed that it was ICC metasized to liver, inoperable and not suited for radiation treatment. Her PET shows about 2/3 of her liver is taken over by tumor cells, the largest one in the right lobe.

    Our oncologist suggested that she immediately begin chemo theraphy consisting of standard gemcitabine and cisplatin, and also a clinical trial for chemo-naive patients aiming to block immune checkpoint consisting of tremelimumab and durvalumab.

    She began her regiment of gem/cis two weeks ago and is thus far enduring it remarkably well. She gets fever symptoms on the third and the fourth day from the treatment, high temperature and general muscle aches. She tries to eat well and much as possible to maintain her weight. She exercises regularly and keeps up with her law school readings even though she withdrew from this semester and probably more.

    It pains to me see this otherwise beautiful, healthy, young person beginning a struggle against enormous odds. There is a fleet of family and friends that is devoted to support her through this, but I feel powerless that I can’t do anything else for her to win over this dreadful illness.

    We live in Korea and are receiving treatment here. But thus far, no doctor is suggesting a solution other than the chemo regiment that she started. Should we seek an overseas opinion from major cancer centers in the US?

    Any feedback or advise will be most appreciated.


    Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

    Not yet open.


    The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered.

    The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer.

    To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients.

    Condition Intervention Phase
    Biliary Tract Neoplasms
    Drug: Durvalumab
    Drug: Tremelimumab
    Drug: Gemcitabine
    Drug: Cisplatin
    Phase 2

    Study Type: Interventional
    Study Design: Intervention Model: Single Group Assignment
    Masking: No masking
    Primary Purpose: Treatment
    Official Title: Biomarker-oriented Study of Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

    Resource links provided by NLM:

    MedlinePlus related topics: Cancer
    Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride
    Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
    U.S. FDA Resources

    Further study details as provided by Seoul National University Hospital:

    Primary Outcome Measures:
    Response rate [ Time Frame: 6 weeks ]
    According to RECIST v1.1 criteria

    Secondary Outcome Measures:
    Disease control rate [ Time Frame: 6 weeks ]
    Progression-free survival [ Time Frame: 6 weeks ]
    Duration of response [ Time Frame: 1 year ]
    Overall survival [ Time Frame: 1 year ]
    Quality-of-life [ Time Frame: 1 year ]

    Overall response rate [ Time Frame: 6 week ]
    According to immune-related response criteria

    Toxicity [ Time Frame: 6 week ]
    CTCAE V4.1

    Estimated Enrollment: 31
    Anticipated Study Start Date: March 2017
    Estimated Study Completion Date: March 2019
    Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
    Arms Assigned Interventions
    Experimental: Durvalumab/Tremelimumab+chemotherapy
    Durvalumab and Tremelimumab in combination with gemcitabine/cisplatin.
    Drug: Durvalumab
    Durvalumab 1.12 g iv on D1 every 3 weeks
    Other Name: MEDI4736
    Drug: Tremelimumab
    Tremelimumab 75mg iv on D1 every 3 weeks
    Drug: Gemcitabine
    Gemcitabine 1000 mg/m2 iv on D1& D8 every 3 weeks
    Drug: Cisplatin
    Cisplatin 25 mg/m2 iv on D1& D8 every 3 weeks

    Detailed Description:

    Rational #1. The incidence of biliary tract cancer (BTC) is higher in Korea than the West. (Korea: 10 new cases/100,000 population every year, the West:1-2 cases/100,100 population every year). Therefore, to conduct clinical study of BTC in Korea is very feasible and efficient.
    Rational #2 The Gemcitabine/cisplatin is the current standard of care in 1st-line treatment for advanced BTC ((N Engl J Med 2010; 362 (14): 1273-81). No one-targeted therapy has been approved in BTC, yet. The overall survival of advanced BTC with cytotoxic chemotherapy is only 8-10 months, in general. Therefore, there is a huge unmet medical need.
    Rational #3 In recent sequencing data of BTC showed the BTC patients with the worse prognosis had significant enrichment of hypermutated tumors and a characteristic elevation in the expression of immune checkpoint molecules. According, immune-modulating therapies also be potentially promising options for these patients (Nat Genet. 2015 Sep;47(9):1003-10.)
    Rational #4 In PDL1 (+) BTC, anti-PD1 Ab shows promising activity as a monotherapy (Bang YJ, et al. ECC/ESMO 2015) In one clinical study of pembrolizumab, 37 out of 89 BTC patients (41.6%) showed the PDL1 (+) tumor. Among 24 PDL1 (+) patients who were enrolled and treated with pembrolizumab, 50% were Asian, 62.5% had ECOG 1, 16.7% had gallbladder cancer, 80% were at the 3rd-line or later setting. Four patients showed PR (3 from Seoul National University Hospital), 4 patients SD, which led the overall response rate of 17.4%. A total 40% of patients showed tumor shrinkage. The decreases in tumor size were generally maintained over time. This study gives us the evidence that immune checkpoint inhibitor is working on BTC likewise other solid tumors.
    Rational #5 In recent studies have shown the combination of CTLA4 inhibitor with anti-PD1/PDL1 agents shows the enhanced clinical activities, especially, regardless of PDL1 status. This combination strategy is being actively under test in many solid tumors.
    Rational #6 Certain chemotherapeutic drugs stimulate cancer-specific immune responses by inducing immunogenic cell death and other effector mechanisms (Immunity 2013, Annu Rev Immunol 2013) With the cytotoxic chemotherapy, the PDL-1 is induced and this increased expression of PDL1 contributes the resistance to cytotoxic chemotherapy. Successful eradication of tumors by immunogenic chemotherapy requires removal of immunosuppressive IgA+, PDL1+plasmocytes (Nature 2015). More importantly, still vast majorities of dynamic changes of immune system by cytotoxic chemotherapy are unanswered. These support that the combination of cytotoxic chemotherapy with immuno-oncology agents including immune checkpoint inhibitors might be efficacious and needed.
    Rational #7 The advantages of “Immunotherapy and cytotoxic chemotherapy” combination are; 1) can explore science on the dynamic immunologic changes by cytotoxic chemotherapy and its overcome by immunotherapy 2) easy way to be incorporated in the current clinical practice 3) can be applied to variety of tumor types such as NSCLC, urothelial cancer. 4) relatively affordable than “immunotherapy and targeted agent” combination. Durvalumab/Tremelimumab in combination of cytotoxic chemotherapy has not been tested, especially in BTC.
    Primary efficacy endpoint is response rate. In BTC, the response rate of 1st-line gemcitabine/cisplatin chemotherapy is about 20% (20% in BT22 clinical trial, 25% in ABC-02 clinical trial). Therefore, we set H0 as 20%, and H1 as 40%. Using 75% of power and a-error of 0.05, a total 28 patients will be needed. When we assume the drop-out rate of 10%, a total of 31 patients will be enrolled.


    Ages Eligible for Study: 18 Years and older (Adult, Senior)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No
    Inclusion Criteria:

    Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer
    Unresectable or recurrent
    chemotherapy -naïve for their unresectable or recurrent cancer (Previous expose to adjuvant chemotherapy is allowed)
    should have measurable lesion
    ECOG 0, 1
    Without previous expose to immune-oncology agents including anti-CTLA4, anti-PD1, anti-PDL1, etc
    Adequate organ function : ANC>1500/mm3, platelet>100K/mm3, HgB>9 g/Dl, bilirubin<1.5 x ULN, ALT/AST<2.5 X UNL, (in case of liver metastasis, <5 Xunl), Cr<1.5 mg/Dl
    Informed consent
    Exclusion Criteria:

    Previous treatment for unresectable or recurrent cancer
    Under immunosuppressive agents higher than equivalent dose of prednisone 10mg/day
    Uncontrolled disease such as current active infection, congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease
    Current active pulmonary tuberculosis
    Current active hepatitis B or hepatitis C (simple carrier is allowed)
    anti-HIV (+)
    Pregnant, breast-feeding women
    Contacts and Locations
    Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03046862

    Contact: Oh ohdoyoun@snu.ac.kr

    Korea, Republic of
    Seoul National University Hospital
    Seoul, Korea, Republic of, 110-744
    Sponsors and Collaborators
    Seoul National University Hospital
    Principal Investigator: Do youn Oh, MD, PhD Seoul National University Hospital
    More Information

    Responsible Party: Do-Youn Oh, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier: NCT03046862 History of Changes
    Other Study ID Numbers: BTC-1st MEDITREME
    Study First Received: February 6, 2017
    Last Updated: February 7, 2017
    Individual Participant Data
    Plan to Share IPD: No

    Studies a U.S. FDA-regulated Drug Product: Yes
    Studies a U.S. FDA-regulated Device Product: No
    Product Manufactured in and Exported from the U.S.: No


    In reply to: Husband’s Case


    Just to keep the diary going here…. :)

    He’s going to have a quick five-shot course of radiation for the bone met that’s at the base of his cervical spine–it’s not really that big, and isn’t impinging on the spinal cord or any big nerves as far as can be seen on MRI, but it has fired off all of the muscles around it and his neck and shoulder muscles have been spasm’ed for three weeks now, and even muscle relaxants and an upping of his pain meds haven’t settled it down, hence the decision to zap it. He’s also now getting a steroid pack to help with the inflammation.

    I asked the radiation oncologist about his other numerous bone mets, and she said that none of them have any look that is currently concerning to her, so that’s a ray of good news.

    We have sent his records to NIH, for not only Melinda’s trial but also the trial that combines two checkpoint inhibitors (Tremelimumab and Durvalumab), and also can include either radiofrequency ablation or cryoablation, depending on which arm he’d end up in. So for now, given that he needs a four-week washout from his trial drug before moving forward with either of those, we aren’t doing any systemic treatment at the moment. But other than the neck stuff, he feels pretty good. Still eating well, which to me is always a positive sign!

    (I also started reading up more on the combination of checkpoint inhibitors with radiation, and there seems to be a lot of interest in the research community about how radiation seems to fire off positive immune responses that then checkpoint inhibitors can enhance even further. Very interesting….)


    Our son Sean was receiving Gem/Cis from Aug ’15 until June ’16, when scans showed some progression. He also received three TACE treatments, which seemed to help control the tumors for a time.

    We have been in communication with a group at NIH since July. Yesterday, he was able to start on a trial combining Tremelimumab and Durvalumab. The study number is 11-C-0112.

    The drugs have been used in combination for some other cancers (NSCLC and melanoma), but this is the first try on cholangio. I think there is at least one other cholangio patient in this trial.

    No side effects yet, but it’s just been hours since he received the infusions.


    maria …you are welcome. We are addressing the problems with clinical trials difficulties. Changes are under way.
    Opdivo also is a PD-1 inhibitor undergoing clinical trials, as is Tremelimumab. The options are increasing as moleculars and immune checkpoint inhibitors are at the forefront of cancer research. Depending on the molecular alterations of your Mom’s tumor, other targeted agents may be available. But, all are under investigation in clinical research studies.

    I addressed both Tapur and MATCH in my presentation at our annual conference:
    Day 2, Clinical
    scroll down to:
    CCF Advocacy Update – Marion Schwartz, CCF Chief Advocacy Officer


    anyone part of this? They opened it to CC a few months ago



    Tremelimumab, a monoclonal antibody against CTLA-4, in combination with subtotal ablation (trans-catheter arterial chemoembolization [TACE], radiofrequency ablation [RFA] or cryoablation) in patients with hepatocellular carcinoma (HCC) and biliary tract carcinoma (BTC).



    Tremelimumab-associated tumor regression following after initial progression: two case reports.

    Sounds promising to me, fingers crossed.


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