CMK389 / Novartis - LARVOL DELTA

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=62 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Immunology • Sarcoidosis

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=62 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Sarcoidosis

A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=69 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Apr 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Immunology • Sarcoidosis

A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=69 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. (PubMed, Lancet) - P3 | "Gemcitabine-platinum combination chemotherapy initiated within 90 days after nephroureterectomy significantly improved disease-free survival in patients with locally advanced UTUC. Adjuvant platinum-based chemotherapy should be considered a new standard of care after nephroureterectomy for this patient population."

Clinical • Journal • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Renal Disease • Solid Tumor • Urothelial Cancer

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Immunology • Sarcoidosis

"China's Communist Party to hold sixth plenum on Nov 8-11 -state media https://t.co/0aosjzHJJi" (@Reuters)

[VIRTUAL] Long-term benefit of adjuvant dabrafenib + trametinib (D+T) in patients (pts) with resected stage III BRAF V600–mutant melanoma: Five-year analysis of COMBI-AD. (ASCO 2020) - P3 | "As of the data cutoff (Nov 8, 2019), 190 of 438 pts in the D+T arm and 262 of 432 pts in the PBO arm had an RFS event. This 5-year analysis confirms the long-term benefit of adjuvant D+T in pts with resected stage III BRAF V600E/K–mutant melanoma. Research Funding: Novartis Pharmaceuticals Corporation"

Clinical • Melanoma • Oncology • Solid Tumor • BRAF

Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial. (PubMed, Lancet) - "For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service."

Clinical • Journal • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Oncology • Pulmonary Embolism • Solid Tumor • Thrombosis • Venous Thromboembolism

Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. (PubMed, Lancet Respir Med) - P2 | "Savolitinib yielded promising activity and had an acceptable safety profile in patients with pulmonary sarcomatoid carcinoma and other NSCLC subtypes positive for METex14 skipping alterations. Savolitinib could therefore be a novel treatment option in this population."

Clinical • Journal • P2 data • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • MET

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2; N=66; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Oct 2022 ➔ Mar 2023; Trial primary completion date: Jul 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Immunology • Sarcoidosis • FDG PET

A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2; N=64; Recruiting; Sponsor: Novartis Pharmaceuticals

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2; N=66; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: May 2022 ➔ Oct 2022; Trial primary completion date: Feb 2022 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Immunology • Sarcoidosis • FDG PET

Trajectories of asthma and allergies from 7 years to 53 years and associations with lung function and extrapulmonary comorbidity profiles: a prospective cohort study. (PubMed, Lancet Respir Med) - "Distinct longitudinal trajectories of asthma and allergic disease from childhood to 53 years are associated with different profiles of extrapulmonary comorbidities and varying risk of COPD. These findings can inform a personalised approach in clinical guidelines and management focusing on treatable traits. Comorbidity profiles are a new target for early identification and intervention."

Clinical • Journal • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Dermatology • Food Hypersensitivity • Immunology • Psychiatry • Respiratory Diseases

"#COVID19WI Nov 8, 2020" (@mtmdphd)

Infectious Disease • Novel Coronavirus Disease

Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial. (PubMed, Lancet Child Adolesc Health) - P=N/A | "Omitting early parenteral nutrition use for critically ill children did not adversely affect long-term outcomes 4 years after randomisation and protected against emotional and behavioural problems, further supporting the deimplementation of early parenteral nutrition."

Clinical • Journal • Critical care • Pediatrics • Psychiatry

Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "The addition of pembrolizumab to standard chemotherapy maintained GHS/QOL, with improved GHS/QOL scores at week 21 in the pembrolizumab plus chemotherapy group compared with the placebo plus chemotherapy group. These data further support use of pembrolizumab plus pemetrexed-platinum as first-line therapy for patients with metastatic non-squamous non-small-cell lung cancer."

Clinical • IO Biomarker • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • Thoracic Cancer

Causes of stillbirths among women from South Africa: a prospective, observational study. (PubMed, Lancet Glob Health) - "Targeted investigation of stillbirths (even without fetal autopsy) can ascertain a cause of stillbirth in most cases. Further studies using such investigations are needed to inform the prioritisation of interventions to reduce stillbirths globally."

Clinical • Journal • Observational data • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Obesity

"I haven’t had a good night’s sleep since Nov 8, 2016." (@DrDonnica)

"By coat rack near Sturbridge, Plymouth! @AMERSA_tweets - #tweetup #AMERSA2019 Fri Nov 8, 10-10:15 @honoraenglander @back2brains @RichBottner @UnhealthyAlcDrg @DrMelissaWeimer @DrChinazo @DrAyanaJordan @syoungmd @miriamh_harris @jtetrault17 @nicholaschadi @simkimmel invite others!" (@XimenaLevander)

Clinical

"Are you attending the #KidneyWk? Do you want to network with the #NephJC community? Like + follow to win 2 tickets to the @NSMCInternship graduation and awards ceremony on Nov 8, 7-9 pm in Washington." (@NephroKarger)

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