Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery

Participants received 200 mg of canakinumab in combination with 200 mg of pembrolizumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery

Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery

200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks

Canakinumab

200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks

Novartis Pharmaceuticals

The purpose of this study was to evaluate the major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR of pembrolizumab as a single agent and the dynamic of the tumor microenvironment changes on treatment.

This was a randomized, phase II, open-label study evaluating canakinumab, an anti-IL-1β monoclonal antibody, or pembrolizumab, a monoclonal antibody designed to block the PD-1 receptor, as monotherapy or in combination as neoadjuvant therapy. The study population included adult subjects with resectable non-small cell lung cancer (NSCLC) planned for surgery in approximately 4-6 weeks. Subjects were treated for a maximum duration of 6 weeks (2 cycles) until surgery, progression, unacceptable toxicity or discontinuation from the study treatment for any other reason.

Subjects were randomized in a 2:2:1 ratio to one of the 3 treatment arms (canakinumab alone or canakinumab in combination with pembrolizumab or pembrolizumab alone). Surgery was performed between 4 to 6 weeks after the first dose of study treatment.

All randomized subjects were followed for safety for up to 130 days following the last dose of study treatment (safety follow-up period).

This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had \>10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder.

MPR was assessed at the time of surgery in all subjects randomized to canakinumab monotherapy and in combination with pembrolizumab based on central review.

Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had a canakinumab ADA positive result at baseline

Canakinumab ADA incidence on treatment was calculated as the percentage of participants who were canakinumab treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and canakinumab treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

Pembrolizumab ADA prevalence at baseline was calculated as the percentage of participants who had a pembrolizumab ADA positive result at baseline

Pembrolizumab ADA incidence on treatment was calculated as the percentage of participants who were pembrolizumab treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and pembrolizumab treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

ORR is defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per local investigator's assessment by RECIST 1.1.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters

Canakinumab serum concentrations were determined at the specified time points.

Pembrolizumab serum concentrations were determined at the specified time points.

Surgical feasibility rate was defined as the percentage of subjects who underwent surgery following study treatment.

MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had \>10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder.

MPR was assessed at the time of surgery in all subjects randomized to pembrolizumab monotherapy arm based on central review.

MPR was defined as the percentage of participants with ≤10% residual viable tumor cells on surgical samples. MPR was assessed at the time of surgery based on central review. The difference in MPR rate between the canakinumab plus pembrolizumab arm and the pembrolizumab arm based on central review along with the Chang and Zhang confidence interval was assessed.

MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had \>10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder.

MPR was assessed at the time of surgery in all subjects based on local review.

MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had \>10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder.

MPR rate was analyzed by the biomarker subgroups at baseline. Biomarkers included PD-L1, CD8, hs-CRP and hs-IL-6.

Any sign or symptom that occurs during the study treatment plus the 130 days post treatment

Canakinumab Monotherapy

Canakinumab + Pembrolizumab

Pembrolizumab Monotherapy

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Study director

All subjects who were randomized to canakinumab monotherapy or canakinumab in combination with pembrolizumab

Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Canakinumab Monotherapy and in Combination With Pembrolizumab Based on Central Review

All subjects randomized to canakinumab monotherapy or canakinumab in combination with pembrolizumab who received at least one dose of canakinumab.

Canakinumab Antidrug Antibodies (ADA) Prevalence

Canakinumab ADA Incidence

All subjects randomized to canakinumab in combination with pembrolizumab or pembrolizumab monotherapy who received at least one dose of pembrolizumab.

Pembrolizumab ADA Prevalence

Pembrolizumab ADA Incidence

FAS including all subjects to whom study treatment was assigned by randomization.

Overall Response Rate (ORR) Based on Local Investigator Assessment Using RECIST v1.1

Cycle 1

Cycle 2

All participants who received at least one dose of canakinumab with at least one evaluable pharmacokinetic (PK) sample. Number analyzed corresponds to the number of participants with an evaluable PK sample at the specified time point

Serum Canakinumab Concentration

Cycle 1 predose

Cyle 1 0.5 hours post dose

Cycle 2 predose

All participants who received at least one dose of pembrolizumab with at least one evaluable PK sample. Number analyzed corresponds to the number of participants with an evaluable PK sample at the specified time point

Serum Pembrolizumab Concentration

Surgical Feasibility Rate

All subjects who were randomized to pembrolizumab monotherapy arm

Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Pembrolizumab Monotherapy Based on Central Review

All subjects who were randomized to canakinumab in combination with pembrolizumab or pembrolizumab monotherapy arms

Difference in Major Pathological Response (MPR) Rate Between the Canakinumab Plus Pembrolizumab Arm and the Pembrolizumab Arm Based on Central Review

Major Pathological Response (MPR) Rate at the Time of Surgery in All Subjects Based on Local Review

PD-L1: <1%

PD-L1: 1-49%

PD-L1: >=50%

hs-CRP: <2mg/L

hs-CRP: >=2mg/L

hs-IL-6: <Q1 (2.52 mg/L)

hs-IL-6: >=Q1 (2.52 pg/mL) to <Q2 (5.36 pg/mL)

hs-IL-6: >=Q2 (5.36 pg/mL) to <Q3 (12.03 pg/mL)

hs-IL-6: >=Q3 (12.03 pg/mL)

CD8: <3%

CD8: >=3%

All subjects to whom study treatment was assigned by randomization. Number analyzed is the number of participants with data available for analysis for each category

Major Pathological Response (MPR) Rate Based on the Levels of Biomarkers

Treatment Period

Safety Follow-up Period

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

Anesthetics

Group of patients operated with open approach for colorectal cancer

Group of patients operated with laparoscopic approach for colorectal cancer

Open colectomy. Epidural anaesthesia used

Open colectomy

Laparoscopic colectomy. Epidural anaesthesia used

laparoscopic colectomy

Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer

Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer

Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach

University of Ioannina

G. Hatzikosta General Hospital

George Pappas-Gogos,MD

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Body Weight

Weight Loss

Polycystic Ovary Syndrome

Dilatation, Pathologic

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Natriuretic Agents

Reproductive Control Agents

Metformin

Drospirenone

Ethinyl Estradiol

Drospirenone and ethinyl estradiol combination

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Hormones

Hormone Antagonists

Diuretics

Diuretics, Potassium Sparing

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Estrogens

Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months

Metformin, Ethinylestradiol 30µg-Drospirenone

Carmen Georgescu

The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum hsCRP,lipids,insulin resistance and body composition in young women with PCOS.

Women with polycystic ovary syndrome (PCOS) frequently cluster several cardiovascular risk markers and early subclinical atherosclerosis. Because combined oral contraceptives (COCs), the most common treatment of this disease, might adversely influence insulin resistance, glucose tolerance, lipid profile or aggravate chronic inflammation the possibility of worsening the already unfavorable cardiovascular risk profile of PCOS subjects is of concern. On the contrary, the insulin sensitizer metformin has been shown to ameliorate insulin resistance, reduce hyperandrogenism and triglyceride levels and also to improve endothelial structure and function in PCOS. Drospirenone (DRP) is a progestin with antiandrogenic and antimineralocorticoid activity. However, the studies assessing the effect of the COC containing 30 µg EE+3mg DRP (DRP/EE30µg) on surrogate markers of atherosclerosis are few and inconclusive. Therefore,the purpose of the present study is to assess the effects of the oral contraceptive DRP/EE30µg combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction, i.e. flow-mediated dilation and serum endothelin-1, serum hsCRP,lipids, and insulin resistance in young women with PCOS.

Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome

Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS

Iuliu Hatieganu University of Medicine and Pharmacy

Associated Professor

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Pemetrexed

Cisplatin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy

canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy

canakinumab every 3 weeks (squamous and non-squamous)

canakinumab

canakinumab placebo every 3 weeks (squamous and non-squamous)

canakinumab matching placebo

200 mg every 3 weeks (squamous and non-squamous)

pembrolizumab

Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.	NCT03968419	Non-small Cell ...	Canakinumab Pembrolizumab	18 Years -	Novartis
Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer	NCT00928928	Colorectal Canc...	Open colectomy laparoscopic co...	-	G. Hatzikosta General Hospital
Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome	NCT01459445	Polycystic Ovar... Endothelial Dys...	Metformin, Ethi...	15 Years - 35 Years	Iuliu Hatieganu University of Medicine and Pharmacy
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects	NCT03631199	Non-small Cell ...	canakinumab canakinumab mat... pembrolizumab carboplatin cisplatin paclitaxel nab-paclitaxel pemetrexed	18 Years -	Novartis

Spots Global Cancer Trial Database for hscrp

Every month we try and update this database with for hscrp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hscrp

Every month we try and update this database with for hscrp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hscrp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.