Avelumab for Tumors, Solid

Phase-Based Estimates
2
Effectiveness
3
Safety
Chonnam National University Hwasun Hospital (13868), Hwasun-gun, Korea, Republic of
Avelumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Tumors, Solid

Study Summary

This study is evaluating whether avelumab, a drug which targets a protein on cancer cells, is safe and effective in treating cancer.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Avelumab will improve 1 primary outcome and 3 secondary outcomes in patients with Tumors, Solid. Measurement will happen over the course of From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab).

Year 5
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
Overall Survival (OS)
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Year 5
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Avelumab
Decreased appetite
20%
Cough
20%
Dyspnoea
19%
Fatigue
18%
Infusion related reaction
14%
Nausea
14%
Asthenia
14%
Pyrexia
13%
Weight decreased
13%
Anaemia
13%
Back pain
12%
Diarrhoea
11%
Constipation
11%
Vomiting
10%
Disease progression
10%
Rash
8%
Headache
8%
Pruritus
7%
Upper respiratory tract infection
7%
Chills
7%
Arthralgia
7%
Pain in extremity
6%
Haemoptysis
6%
Productive cough
6%
Musculoskeletal pain
6%
Hypothyroidism
6%
Insomnia
5%
Oedema peripheral
5%
Myalgia
4%
Pleural effusion
3%
Neuropathy peripheral
2%
Chronic obstructive pulmonary disease
2%
Malaise
2%
Stomatitis
2%
Death
2%
Pneumonia
2%
Sepsis
1%
Acute kidney injury
1%
Interstitial lung disease
1%
Cardiac arrest
1%
Abdominal pain
1%
Neutropenia
1%
Hypercalcaemia
1%
Colitis
1%
Respiratory tract infection
1%
Femoral neck fracture
1%
Hypoxia
1%
Depressed level of consciousness
1%
Lung infection
1%
Hyperkalaemia
1%
Pneumonitis
1%
Pulmonary embolism
1%
Pericardial effusion
1%
White blood cell count decreased
1%
Neutrophil count decreased
1%
Pain
1%
Metastases to central nervous system
1%
Cardiac tamponade
1%
Metastases to bone
1%
Superior vena cava syndrome
1%
Respiratory failure
1%
Alopecia
1%
Peripheral sensory neuropathy
1%
Hypersensitivity
1%
Acute respiratory failure
1%
Mucosal inflammation
1%
Confusional state
1%
Malignant pleural effusion
1%
Atrial fibrillation
1%
Hyperglycaemia
1%
Renal failure
0%
Diabetic gangrene
0%
Henoch-Schonlein purpura
0%
Intestinal perforation
0%
Serratia infection
0%
Metastases to meninges
0%
Osteoporotic fracture
0%
Gastroenteritis
0%
Syncope
0%
Encephalitis
0%
Febrile neutropenia
0%
Hypokalaemia
0%
Klebsiella infection
0%
Ileus
0%
Agitation
0%
Pneumocystis jirovecii pneumonia
0%
Septic shock
0%
Hemiparesis
0%
Cerebral infarction
0%
Lower respiratory tract infection
0%
Haemorrhage intracranial
0%
Vision blurred
0%
Dehydration
0%
Non-cardiac chest pain
0%
Asphyxia
0%
Sudden cardiac death
0%
Hydrothorax
0%
Left ventricular dysfunction
0%
Pneumothorax
0%
Colorectal cancer
0%
Melaena
0%
Gastrointestinal pain
0%
Neutropenic infection
0%
Deep vein thrombosis
0%
Renal impairment
0%
Pneumonia aspiration
0%
Dyspnoea exertional
0%
Subileus
0%
Cardiac failure
0%
Streptococcal infection
0%
Post procedural haemorrhage
0%
Metastases to liver
0%
Leukopenia
0%
Bronchial obstruction
0%
Postoperative wound infection
0%
Pulmonary haemorrhage
0%
Cardiovascular insufficiency
0%
Ascites
0%
Metastatic neoplasm
0%
Gastritis erosive
0%
Gastric haemorrhage
0%
Bone pain
0%
Febrile bone marrow aplasia
0%
Intervertebral disc protrusion
0%
Aortic aneurysm
0%
Pneumonia streptococcal
0%
Urosepsis
0%
Alanine aminotransferase increased
0%
Pathological fracture
0%
Autoimmune myocarditis
0%
Autoimmune thyroiditis
0%
Acute coronary syndrome
0%
Infective exacerbation of chronic obstructive airways disease
0%
Dysgeusia
0%
Hemiplegia
0%
Soft tissue infection
0%
Lumbar vertebral fracture
0%
Cystic lung disease
0%
Cholelithiasis
0%
Aspartate aminotransferase increased
0%
Acute myocardial infarction
0%
Loss of consciousness
0%
Peripheral arterial occlusive disease
0%
General physical health deterioration
0%
Cardiomyopathy
0%
Vertigo
0%
Intermittent claudication
0%
Neutropenic sepsis
0%
Colitis ulcerative
0%
Adrenal insufficiency
0%
Atelectasis
0%
Pleural infection
0%
Meningitis
0%
Appendicitis
0%
Bronchitis
0%
Peritonitis
0%
Urinary tract infection
0%
Myocardial infarction
0%
Rash maculo-papular
0%
Angioedema
0%
Spinal cord compression
0%
Dysphonia
0%
Oesophagobronchial fistula
0%
Brain contusion
0%
Blood creatine phosphokinase increased
0%
Nephrolithiasis
0%
Hypophagia
0%
Acute respiratory distress syndrome
0%
Tumour pain
0%
Arrhythmia supraventricular
0%
Neurotoxicity
0%
Balance disorder
0%
Post herpetic neuralgia
0%
Seizure
0%
Cholangitis
0%
Thrombotic cerebral infarction
0%
Chest pain
0%
Paraesthesia
0%
Spinal compression fracture
0%
Malignant neoplasm progression
0%
Hypotension
0%
Femur fracture
0%
Dysphagia
0%
Infection
0%
Cardiac failure acute
0%
Cardiac failure congestive
0%
Hyponatraemia
0%
Cerebrovascular accident
0%
Angina unstable
0%
Ileus paralytic
0%
Hepatic function abnormal
0%
Electrolyte imbalance
0%
Gamma-glutamyltransferase increased
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02395172) in the Avelumab ARM group. Side effects include: Decreased appetite with 20%, Cough with 20%, Dyspnoea with 19%, Fatigue with 18%, Infusion related reaction with 14%.

Trial Design

2 Treatment Groups

Control
Avelumab

This trial requires 161 total participants across 2 different treatment groups

This trial involves 2 different treatments. Avelumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Avelumab
Drug
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline up to 5 years for reporting.

Closest Location

Norwalk Hospital - The Whittingham Cancer Center - Norwalk, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany
Merck Serono Co., Ltd (Japan)
Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
Other protocol defined inclusion criteria could apply.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for tumors, solid?

Add answer

The following are the most frequently used treatments in patients with tumors, solid: [1. Surgery: resection (debulking), RFA: radio frequency ablation]; [2. CIMT: chemotherapy; [3. Radiotherapy: radiation therapy; 4. CCRT: chemotherapy, radiation therapy\n

Unverified Answer

What causes tumors, solid?

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The cause of most human cancers has yet to be elucidated. The tumour is a complex combination of cells that work together to develop in one place and then spread through the body. It is this tumour growth or spread that affects our health and ultimately leads to death.

Unverified Answer

What is tumors, solid?

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Tumors, solid or neoplasms are tumours that occur within or on any or all body organ or system. Tumours form when cells grow or divide rapidly out of control. They can form as a result of normal cellular processes, but can also form abnormally as the result of a problem such as exposure to carcinogens or radiation. Tumour-forming cells normally have the ability to replicate their genomes and to divide without limit unless some form of genetic interference is present - a process known as cell 'homeostasis'. Tumours are often classified by the types of cells and structures that are affected, but, when this is not possible, by the site of occurrence.

Unverified Answer

Can tumors, solid be cured?

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In general terms, it has become increasingly clear that solid tumors cannot be cured. There are still many exceptions, but the cure of solid tumors in general is rare.

Unverified Answer

How many people get tumors, solid a year in the United States?

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About 9.2 million US adults are diagnosed with cancer of the skin. As of 2006 this represented about 0.5% of all cancer cases in the Western world and about 0.6% of all cancer cases in the United Kingdom and the United States of America, making it a very common cancer.\n

Unverified Answer

What are the signs of tumors, solid?

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The most common tumors, solid include the following: colon cancer, breast cancer, and ovarian cancer. The presence of ileosigmoid polyps is also a common finding. Other commonly detected tumors, solid include the following: carcinoid tumors, metastatic carcinomas, glomus tumors, metastatic choriocarcinomas, paragangliomas, thymoma, mediastinal germ cell tumors that mimic carcinoma, and lung cancer. The presence of gallstones or jaundice is also a common finding. Coughing up blood and difficulty swallowing are also common signs of tumors, solid.

Unverified Answer

Who should consider clinical trials for tumors, solid?

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Physicians should tailor clinical trial treatment recommendations to individual patients by considering each patient's medical evaluation, treatment history, and patient preference, as well as the clinical characteristics of the patient population in which a clinical trial will be used.

Unverified Answer

What is the average age someone gets tumors, solid?

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The mean age at diagnosis of primary tumors in solid non-malignant sites is 60.0 years with a standard deviation of 15.3 years. There have been two recent advances in cancer treatment that may help improve clinical outcomes for patients with solid tumors; anti-angiogenesis agents in addition to targeted therapies. However, there is still much work to be done in further examining how these new forms of treatment can improve outcomes.

Unverified Answer

Does tumors, solid run in families?

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We observed a higher prevalence of SLLC and its associated tumors in men. The observed male predominance of SLLC and its associated tumors is a novel finding. To our knowledge, this is the first study to report on a family-based cancer risk factor in SLLC patients. More studies are needed to elucidate the role of genetic and environmental factors in this particular manifestation of cancer. Furthermore, future studies can focus on other hereditary cancer syndromes, and SLLC patients in order to better understand the genetics of SLLC and its associated tumors.

Unverified Answer

Has avelumab proven to be more effective than a placebo?

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The safety and efficacy of avelumab are confirmed. Although no statistically significant difference was detected in median time to response between avelumab- and a placebo-treated patients, avelumab may be significantly more effective compared to placebo as measured as time to response. Avelumab may induce faster responses in patients than placebo, and it may be more effective compared to placebo when patients may have been enrolled in the study in terms of an early clinical response rather than later progression of disease.

Unverified Answer

What is the primary cause of tumors, solid?

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This information is important because we cannot diagnose a tumor in only one clinic. For example, the commonest cause of cancer in the pancreas is pancreatic cancer.

Unverified Answer

Is avelumab safe for people?

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This phase III trial is the first to examine the safety of avelumab in combination with pembrolizumab in adults with metastatic solid tumors or cancers with PD-L1 expression, and the safety of avelumab in people with solid tumours, including metastatic cancers. summary: In a recent study, findings is evaluating whether avelumab is safe and effective for people with metastatic cancer.

Unverified Answer
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