Home Forums Melanoma Diagnosis: Stage IV IPI vs. NIVO Trial opening in March first in Europe!

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  • #22392
    Catherine Poole
    Keymaster

    Although not officially listed on clinicaltrials.gov, I received word this trial will open FIRST in Europe! Belgium will be the first sites, then U.S. and 25 other countries. I will post the locations when I get the details. I think this will be an interesting trial for treatment naïve patients to enter. And the results even more interesting.

    #66641
    Thomvdv
    Participant

    waaauw! have to be treatment negative though???

    #66642
    Catherine Poole
    Keymaster

    Yes,no prior IPI/PD1, but probably will allow prior BRAF. Don’t hold me to that until they get it up on Clinicaltrials.gov though. I’ve reached out to the docs I think will be involved to get more information too.

    #66643
    Thomvdv
    Participant

    oh thank! good news!!

    but still, our onc thinks this combo is waaaaay too toxic and they still not pretty sure ‘what we are doing there’..

    #66644
    Thomvdv
    Participant

    (i shared it on a European Melanoma board because a lot of people were asking about this combo)

    #66645
    Catherine Poole
    Keymaster

    It will be randomized but I’m really interested to see PD1 and IPI up against each other. I belong to that European board, no problem!

    #66646
    Thomvdv
    Participant

    aaaah VERSUS eachother…

    #66647
    Thomvdv
    Participant

    is it trail CA209-238?

    –> it’s for patients who have been operated, i believe, and they are been followed for a year on ipi or on nivo

    #66648
    Catherine Poole
    Keymaster

    I did hear from UZ Brussel and they said: This trial will be initiated on the 12th of march at the UZ Brussel.

    “We are happy to assist any patient who is looking for access to this trial.” Contact:

    Sofie Wilgenhof MD

    Laboratory of Cellular and Molecular Therapy Department of Physiology and Immunology Medical School of the Free University Brussels (VUB) Laarbeeklaan 103/E228

    1090 Brussel

    Tel : 02/477.45.65

    Fax : 02/477.45.68

    Sofie.Wilgenhof@vub.ac.be

    Medische Oncologie

    Oncologisch Centrum

    Laarbeeklaan 101

    1090 Brussels, Belgium

    http://www.uzbrussel.be

    #66649
    Thomvdv
    Participant

    if it is that trail i mentioned, is it adjuvant?

    #66650
    Catherine Poole
    Keymaster

    I don’t have the NCT number yet, but it is for treatment naive patients. Here is some of the language for it sent by the doctor, looks like braf therapy ok, but no prior interferon! It is an adjuvant trial for NED patients.

    Here is the description:

    Study Population: High risk, completed resected Stage IIIb/c and IV melanoma.

    Key Inclusion Criteria:

    •At least 15 years of age

    •All subjects must be either Stage IIIb/c or Stage IV AJCC (7th edition) and have histologically confirmed

    melanoma that is completely surgically resected in order to be eligible. Subjects must have been surgically

    rendered free of disease with negative margins on resected specimens.

    •If Stage III melanoma (whether Stage IIIb or IIIc) the subjects must have clinically palpable lymph nodes that

    are confirmed as malignant on the pathology report and /or ulcerated primary lesions. The pathology report of

    the lymph nodes must be reviewed and approved by the sponsor prior to randomization.

    •Complete resection of Stage IIIb/c lymph nodes or of metastatic disease with margins negative for disease must

    be documented on the pathology report.

    •Complete resection must be performed within 12 weeks prior to randomization

    •All patients must have disease-free status documented by a complete physical examination and imaging studies

    within 4 weeks prior to randomization. Imaging studies (CT) must include neck, chest, abdomen, pelvis and all

    known sites of disease and brain MRI or CT (if MRI is contraindicated).

    •Tumor tissue from the resected site of disease must be provided for biomarker analyses. In order to be

    randomized, a subject must have a PD-L1 expression classification (positive, negative/or indeterminate).

    Key Exclusion Criteria:

    •Ocular/uveal melanoma

    •Subjects with active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, residual

    hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as

    vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.

    •Subjects with previous malignancies are excluded unless a complete remission was achieved at least 3 years

    prior to study entry and no additional therapy is required or anticipated to be required during the study period

    (exceptions include but are not limited to, non-melanoma skin cancers; in situ bladder cancer, in situ gastric, or

    in situ colon cancers; cervical cancers/dysplasia; or breast carcinoma in situ)

    •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone

    equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical

    steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the

    absence of active autoimmune disease.

    •Prior therapy for melanoma except surgery for the melanoma lesion(s) and except adjuvant RT after

    neurosurgical resection for CNS lesions. Specifically subjects who received prior therapy with interferon, anti-

    PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other

    antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways) are not eligible.

    #66651
    bettin
    Participant

    This is an adjuvant trial for patients who are NED after surgery and the trial needs to be started within 12 weeks after surgery, so the time-window is very narrow.

    As for prior BRAF therapy, that would be a patient taking BRAFis, having massive shrinkage, surgery to remove the reminding tumours to be NED and then enter this trial- not sure how many patients will fit that bill.

    So it’s not a way to get PD1 first-line for stage IV patients with inoperable tumour burden.

    Best,

    Bettina

    #66652
    Jupke
    Participant

    So this will be a trial to determine if adjuvant therapy following surgery will show some survival benefit between Ipilimumab and Nivolumab in comparison.

    I guess this also will we be compared with surgery only.

    Is this how I should understand it?

    #66653
    Catherine Poole
    Keymaster

    Basically it is for newly diagnosed patients, who have completed surgery to remove their primary lesion and/or tumors/positive nodes. It is to see which drug, head to head, IPI/PD1 works best in this adjuvant setting for stage IV. I am not as enthused as I was initially because as Bettina points out this may be a small subset of patients. However, I do feel it is first line therapy for those who are newly diagnosed. It may also settle the efficacy of the two agents although most of know which is better and has less side effects for the most part is the PD1.

    #66654
    Jupke
    Participant

    Given the explicit request for tumor tissue I wouldn’t be surprised this is also – if not all – about identifying potential markers or precursors to predict therapeutic efficacy.

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