Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
Complete resection within 13 weeks prior to the first dose of pembrolizumab
Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Normal organ and marrow function reported at screening
Key Exclusion Criteria:
Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
Live vaccine within 30 days prior to the first dose of pembrolizumab
Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
Active autoimmune disease
Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
Solid organ or allogeneic bone marrow transplant
Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
Prior interstitial lung disease
Clinically significant heart failure
Known history of human immunodeficiency virus (HIV)
Known active hepatitis B or C
Active infection requiring treatment
Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Not meaning to derail the thread, but ... What typo blew up the space shuttle? Challenger was lost when managers in a rush to launch overrode the recommendations of Thiokol engineers. Columbia was lost when a piece of insulation struck the leading edge of the left orbiter wing at launch and the risk to the shuttle was not recognized by those in charge.
Headline is incorrect; Rybelsus, an oral semaglutide, was approved in 2019. Maybe oral Wegovy is the first oral GLP-1 approved for obesity rather than diabetes.
I see a flash of white text on a dark background, then "Application error: a client-side exception has occurred (see the browser console for more information)." in black on the same very dark background.
Chrome on Win 10
As others have mentioned, it's important to note that this is not a trial of ECMO vs no ECMO, but of immediate ECMO vs usual care including ECMO if needed, and that 39% of the control arm wound up receiving ECMO, which could have the effect of reducing apparent treatment benefit. Also, the 28% reduction in the primary endpoint could well reach statistical significance if the trial numbers were larger. Finally, this was for patients with cardiogenic shock, most likely predominantly heart attack patients. They likely represent a smallish portion of the patients who might be considered for ECMO, so one can't generalize to all scenarios.
This reminds me of a story from several years ago where, as part of a bike-a-thon to benefit Parkinson's research, a Parkinson's patient rode a tandem bike with a family member providing the pedal power. This "passive exercise" led to a several day remission of Parkinsonian symptoms. The current article would provide a plausible mechanism for this effect.
A minor point that may have some relevance here. When I was doing genealogical research on my great grandfather who served in the US Civil War, I read that at the time, your legal age was considered to be the age you would attain by the end of the calendar year, so everyone officially aged up on January 1. By this convention, many 17 year-olds who enlisted would have been legally 18 and did not actually lie about their age.
Eligibility Criteria
Key Inclusion Criteria:
Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
Complete resection within 13 weeks prior to the first dose of pembrolizumab
Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Normal organ and marrow function reported at screening
Key Exclusion Criteria:
Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
Live vaccine within 30 days prior to the first dose of pembrolizumab
Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
Active autoimmune disease
Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
Solid organ or allogeneic bone marrow transplant
Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
Prior interstitial lung disease
Clinically significant heart failure
Known history of human immunodeficiency virus (HIV)
Known active hepatitis B or C
Active infection requiring treatment
Ages Eligible for Study 18 Years and older (Adult, Older Adult )
Sexes Eligible for Study All
Accepts Healthy Volunteers No