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There are many Clinical trials going on for NMIBCs (Non Muscle Invasive Bladder Cancers). Below are a few clinical trials involving immunotherapy drugs which had been approved in Canada for bladder cancers. Pembrolizumab or the brand name Keytruda by MERCK and Atezolizumab (Tecentriq) by Roche had been approved by Health Canada for advanced bladder cancers patients. There may be errors in the description. For detail, check with https://clinicaltrials.gov/
Keynote – 57 Phase 2 trials on Keytruda (infused in to a vein – intravenously) alone for BCG un-responsive NMBIC patients.
A key selection criteria to enroll in the clinical trial is that the patient went through the initial 6 weeks BCG therapy and went on to BCG maintenance therapy then there was recurrence. It is still recruiting but only in Quebec and Ontario according to MERCK Canada. ** This is a single arm trial, which means everyone who participates in the trial will get the same treatment. The efficacy is 40% complete response at 3 month, 22% at 9 month.On December 17, FDA is scheduled to review the result of Keynote-57 clinical trial and determines the treatment worth (efficacy vs toxicity) to the public in US. If it is approved by FDA, then Keytruda therapy for BCG un-responsive NMBIC patients can become “product” which MERCK is allowed to market.
Keynote-676 -Phase 3 for Keytruda + BCG combination for BCG Non-responsive NMBIC patients.
A key selection criteria to enroll in this clinical trial is that the patient went through the initial 6 weeks BCG therapy and had recurrence and has not had yet BCG maintenance therapy. It is recruiting and expects to continue to recruit for awhile. It expects to recruit 550 patients from 116 sites worldwide. There are several trial sites in Canada. ** This is a random trial. The patients who enroll to this trial will either get BCG only treatment or BCG + Keytruda treatment. Patients will not know which treatment is getting I think. I have listed the locations of the trial in Canada below. You can access more information by https://clinicaltrials.gov/ct2/show/NCT03711032.
SWOG 1605 – Phase 2 for Atezolizumab for BCG Non-responsive NMIBC patients. Not recruiting patients now. This clinical trial is being led by Canadian Trials. Chief Investigator is Dr. Peter Black of VGH. Result is yet to come .
Below is the list of trial locations of Keynote – 676
Canada, British Columbia
Exdeo Clinical Research Inc. ( Site 0165)
Recruiting
Abbotsford, British Columbia, Canada, V2T 1X8
Contact: Study Coordinator 6048515667
Silverado Resarch Inc. ( Site 0155)
Recruiting
Victoria, British Columbia, Canada, V8T 2C1
Contact: Study Coordinator 2505929988
Canada, New Brunswick
Horizon Health Network ( Site 0160)
Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contact: Study Coordinator 5068574780
Canada, Ontario
Princess Margaret Cancer Centre ( Site 0153)
Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator 4169462246
Canada, Quebec
CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
Contact: Study Coordinator 4185411000
CIUSSS de l Est de L Ile de Montreal – Hopital Maisonneuve-Rosemont ( Site 0157)
Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Study Coordinator 51425234005853
CHUS – Hopital Fleurimont ( Site 0152)
Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Study Coordinator 819346111012852
Canada
CHU de Quebec – Hotel-Dieu de Quebec ( Site 0151)
Recruiting
Quebec, Canada, G1R 2J6
Contact: Study Coordinator 418525444420414Keynote – 57 Update
Today, the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 9-4 in favor of recommending KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC). Certain patients with high-risk, non-muscle invasive bladder cancer means patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder).
The ODAC discussions were based on the supplemental Biologics License Application (sBLA), currently under priority review at the FDA, seeking approval of KEYTRUDA monotherapy for the treatment ofThis application is based on results from the Phase 2 KEYNOTE-057 trial.
The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committee’s guidance but takes its advice into consideration. Merck anticipates a Prescription Drug User Fee Act (PDUFA), or target action date, in January 2020, based on priority review.
In summary MERCK has passed the first hurdle for Keytruda to be used for NMIBCs. The next step is for MERCK is to pay the fee to FDA to expertise the review and the decision by FDA for Keytruda for NMBIC. It is noted that the new treatment applies to only NMIBCs who had CIS and who are ineligible for RC or have decided bladder preservation.
Joe
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