Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Death

Camurati-Engelmann Disease

All Drugs and Chemicals

Mitogens

Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) per dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

Bintrafusp alfa

Medical Responsible

This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data.

Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study.

The study also includes a 5 years survival follow-up after last dose of the study treatment.

Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation.

Bintrafusp Alfa Program Rollover Study

An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Digestive System Diseases

Behaviors and Mental Disorders

Carcinoma

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Quality of Life

Gallbladder Cancer

patients with biliary obstruction will undergo endoscopic stenting.

Biliary stenting

Pramod Garg, M.D, D.M.

Vikram Bhatia, M.D, D.M.

The purpose of the study is to determine whether palliative biliary stenting improves the quality of life, of gallblader cancer patients, who present with hilar block and obstructive jaundice.

For most patients with gallbladder cancer, cure is not possible and treatment should be therefore aimed at palliation of symptoms and maintaining quality of life (QOL) in the few months between diagnosis and death. Most of these patients suffer from intractable pruritis, pain, anorexia and general debility. Biliary stenting leads to a reduction in pruritis and jaundice, and is commonly offered to many unresectable patients. However stenting related complications like cholangitis, rescue percutaneous treatment and need for prolonged hospitalization often impair the remaining short survival of these patients. In these patients improving the QOL should be the primary focus, and survival a secondary end point in disease management. No study has addressed the issue of QOL of patients with gallbladder cancer, post stenting.

Three clinical studies have evaluated the change in the QOL of patients with malignant biliary obstruction after of endoscopic stenting. Ballinger et al evaluated 19 patients with unresectable pancreatic carcinoma before stenting and upto 12 weeks or death after stenting. The Rotterdam Symptom Checklist and the Hospital Anxiety and Depression Scale were used. Significant improvements were seen in the parameters of mood, indigestion, appetite and level of activity. Luman et al studied 47 inoperable patients with malignant biliary strictures. The European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC QLQ-C30) was used at baseline and 1 month after stenting. For patients successfully completing the follow up, significant improvement in emotional, cognitive , and global health scores was found after stenting. In addition to the expected improvement in pruritis and jaundice , anorexia, diarrhea and sleep pattern were also improved. Abraham et al studied 50 patients with malignant biliary obstruction without liver metastasis considered non surgical candidates, and undergoing palliative biliary stenting. The SF-36 Health Survey Questionnaire was used to quantify QOL at baseline and 1 month after stent insertion. Follow up data was available for only 26 patients. Among these patients a significant reduction in the bilirubin level was associated with improvement in the social function and mental health. A high baseline bilirubin (\> 14mg/dL) was associated with a lack of improvement at 1 month follow up.

Hence existing data regarding improvement in the QOL of patients undergoing palliative biliary stenting is sparce and incomplete. Gallbladder cancer presenting a hilar block is the most common biliary malignancy in India. Hilar tumors are associated with more technical failure of stenting, higher cholangitis rates, earlier stent blockage, and shorter survival as compared to distal biliary tumors. Only 6 patients with Klatskin tumors were included in one of the study.8 Patients with hilar block were either not included6, or were not specified7 in the other studies.

Health related quality of life (QOL) refers to the impact of a medical condition or its treatment on a person's expected physical, psychological and social well being.

Calman states that QOL evaluations measure the difference between the "hopes and expectations" of an individual and that individual's present experience.

The multidimensionality that is commonly assessed in QOL measures includes

1. Physical symptoms of the disease or its treatment or concurrent illness.
2. Functional capacity (ability and energy) for daily routine, social interactions, intellectual activity, emotional reactions and adjustments, economic independence.
3. Self-perception of wellness or its absence. There are two basic types of instruments for measuring the QOL: generic and disease specific. Generic instruments focus on the main components that constitute QOL, and are intended to be applied in a wide range of populations and health states across all diseases. There are many excellent validated self-completion questionnaires for cancer patients eg. EORTC QOL questionnaire, Functional assessment of Cancer Therapy (FACT), Rotterdam Symptom Checklist (RSCL), Functional Living Index Cancer (FLIC). All these questionnaires are multidimensional, and it is rarely required to develop a new instrument.

The EORTC QLQ-C30 has been developed in a multi-cultural setting, and translations are available in 43 languages. The instrument has been shown to be valid, reliable, and responsive to change. Disease specific modules are available to supplement the core questionnaire. Reference data is available for calculating sample size. The questionnaire is easily understood by most patients and is quick to complete (mean time 11 minutes).

The EORTC QLQ-C30 is a 30- item questionnaire composed of multi-item scales and single items that reflects the multidimensionality of the quality of life construct. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), and a global health and quality of life scale. The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, sleep disturbance, constipation and diarrhea), as well as the perceived financial impact of the disease and its treatment. The functional scales have 16 questions, symptom scales have 6 questions, global quality of life has two questions, and there are six single item questions. For ease of interpretation, all scale and item scores are linearly transformed to a 0 to 100 scale. For the 5 functional scales and the global quality of life scale, a higher score represents a better level of functioning. For the symptom oriented scales and items, a higher score corresponds to a higher level of symptoms.

Hence we plan to prospectively study unresectable gallbladder cancer patients with hilar block to evaluate whether palliative stenting improves their quality of life, and whether the benefit afforded outweighs the early and late complications of stenting.

Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.

Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial

All India Institute of Medical Sciences, New Delhi

Additional Professor

Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)

Wearable activity monitor

Gillian Gresham, PhD

Eileen Liu

Stephen Freedland, PhD

BJ Rimel, MD

Brennan Spiegel, MD

Jun Gong, MD

Arash Asher, MD

Andrew Hendifar, MD

Christine Walsh, MD

Edwin Posadas, MD

The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.

Patients diagnosed with stage 3/ 4 cancer will be enrolled. After providing informed consent, patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to continue wearing the monitor for up to a year after end-of-study. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up. Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from end-of-study. They will also be collected at 1 year follow-up. Wearable activity monitor data will be summarized each week for 8 weeks, and then again at 1 year follow-up. Physical activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study). Overall survival will also be assessed up to 1 year from end-of-study. Absolute change in physical activity levels will be correlated with change in performance status and occurrence of AEs and death to better understand the role of remote activity monitoring in cancer patients.

Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients

Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial

Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit

Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.

Physical function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 20 items and a range of 1 (low physical function) to 5 (high physical function). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard cancer population with a mean of 50 and SD of 10.

Distress will be measured using using NIH Patient-Reported Outcomes Measurement Information System (PROMIS), which includes short forms: emotional distress, sleep quality, pain, and fatigue. Items range from 1 (worse outcome) and 5 (best outcome) where a total score will be calculated and converted into standardized t-scores.

A patient is considered adherent if they wear the device at least 10 hours per day for at least 4 of 7 days prior to each study timepoint

Score calculated based on total number of frailty characteristics present using Fried's validated Frailty index. Characteristics of frailty include shrinking (weight loss), weakness (grip strength), poor endurance, exhaustion, slowness, and low activity. The minimal score is 0, indicating absence of frailty, and the highest is 5. Frailty index categories include absence of frailty (score of 0), pre-frail or intermediate frail (1-2 criteria) and frail (\>3 criteria present).

Cedars-Sinai Medical Center

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients

Specialist Palliative Care

Jadwiga Jośko-Ochojska, prof

Łukasz Pietrzyńsi

The aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in Poland. The length of the entire study will be 36 months.

The Impact of SPC on Advanced Breast Cancer Patients

The Influence of Specialist Palliative Care on the Exacerbation of Negative Symptoms, Life Quality and Performance Status of Patients With Advanced Breast Cancer

intensification of patients negative symptoms was assessed by Edmonton Symptom Assessment System (esas)

performance status of patients was assessed by ECOG scale (Eastern Cooperative Oncology Group)

quality of life of patients of patients was assessed by quality of life uniscale (QoLU)

Silesian University of Medicine

Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:

* the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale.

PRO-CTCAE items

Francesco Perrone, MD, PhD

Domenico Galetta, MD

Saverio Cinieri, MD

Alberto Sobrero, MD

Lucia Del Mastro, MD

Emiliano Tamburini, MD

Silvana Leo, MD

Ugo De Giorgi, MD, PhD

Ugo De giorgi, MD

Vincenzo Adamo, MD

Carla Ida Ripamonti, MD

Alice Bergamini, MD

Silvia Della Torre, MD

Sara Di Bella, MD

Sandro Pignata, MD, PhD

Alessandro Morabito, MD

Michele Orditura, MD

Antonio Pizzolorusso, MD

Vincenzo Montesarchio, MD

Vittorina Zagonel, MD

Marcello Tiseo, MD

Camillo Porta, MD

Luigi Cavanna, MD

Patrizia Vici, MD

Antonella Savarese, MD

Salvatore Pisconti, MD

Stefania Gori, MD

The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.

This is a prospective observational study, conducted in Italian cancer centers located Nationwide.

The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting".

The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:

* EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale

Validation of the Italian Version of the PRO-CTCAE

VIP: Validation of the Italian Version of the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Prospective Multicenter Observational Study on Different Cancer Types

Evaluation of the validity (degree to which an instrument accurately measures the underlying phenomenon) of single items of the PRO-CTCAE, Italian version, for each of the type of cancer considered

Evaluation of responsiveness (ability of an instrument to show a change when there has been a change in the phenomenon) of single items of the PRO-CTCAE for each of the types of cancer considered.

Evaluate any differences in psychometric measures according to:

* type of cancer (breast, lung, liver ...)
* type of treatment (chemotherapy, hormone therapy, immunotherapy, ...)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bintrafusp Alfa Program Rollover Study	NCT05061823	Lung Cancer Cancer	Bintrafusp alfa	18 Years -	EMD Serono
Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.	NCT00391183	Gallbladder Can...	Biliary stentin...	18 Years - 90 Years	All India Institute of Medical Sciences, New Delhi
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients	NCT03757182	Cancer Cancer, Metasta... Neoplasms	Wearable activi...	18 Years -	Cedars-Sinai Medical Center
The Impact of SPC on Advanced Breast Cancer Patients	NCT03612934	Breast Cancer Palliative Care Quality of Life Cancer, Breast	Specialist Pall...	33 Years - 91 Years	Silesian University of Medicine
Validation of the Italian Version of the PRO-CTCAE	NCT04416672	Malignant Neopl...	PRO-CTCAE items	18 Years -	National Cancer Institute, Naples
The Impact of SPC on Advanced Breast Cancer Patients	NCT03612934	Breast Cancer Palliative Care Quality of Life Cancer, Breast	Specialist Pall...	33 Years - 91 Years	Silesian University of Medicine
Bintrafusp Alfa Program Rollover Study	NCT05061823	Lung Cancer Cancer	Bintrafusp alfa	18 Years -	EMD Serono
The Impact of SPC on Advanced Breast Cancer Patients	NCT03612934	Breast Cancer Palliative Care Quality of Life Cancer, Breast	Specialist Pall...	33 Years - 91 Years	Silesian University of Medicine

Spots Global Cancer Trial Database for performance status