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February 26, 2015 at 4:21 pm #22392
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.February 26, 2015 at 5:51 pm #66641 waaauw! have to be treatment negative though???February 26, 2015 at 6:49 pm #66642 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.February 26, 2015 at 7:13 pm #66643 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’..February 26, 2015 at 7:22 pm #66644
(i shared it on a European Melanoma board because a lot of people were asking about this combo)February 26, 2015 at 7:51 pm #66645 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!February 26, 2015 at 8:42 pm #66646 aaaah VERSUS eachother…February 26, 2015 at 9:10 pm #66647 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 nivoFebruary 27, 2015 at 3:47 pm #66648
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
Tel : 02/477.45.65
Fax : 02/477.45.68
1090 Brussels, BelgiumFebruary 27, 2015 at 4:30 pm #66649
if it is that trail i mentioned, is it adjuvant?February 27, 2015 at 7:23 pm #66650 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:
•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.February 28, 2015 at 9:34 am #66651bettinParticipant
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.
BettinaFebruary 28, 2015 at 10:31 am #66652JupkeParticipant
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?February 28, 2015 at 12:56 pm #66653
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.February 28, 2015 at 1:41 pm #66654JupkeParticipant 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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