Treatment for Malignancies

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Saskatoon Cancer Centre, Saskatoon, Canada
Malignancies
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called durvalumab can be used to treat cancer.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 4 primary outcomes and 6 secondary outcomes in patients with Malignancies. Measurement will happen over the course of 2 years.

2 years
Efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs as estimated by the percentages of patients who received corticosteroids and developed recurrent or new grade 2 or higher irAEs
Number and severity of adverse events
Objective response rate RECIST 1.1
Objective response rate iRECIST
Substudy A: Efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs as estimated by the percentages of patients who received corticosteroids and developed recurrent or new grade 2 or higher irAEs
Substudy A: Number and severity of adverse events
Substudy A: Objective response rate iRECIST
Substudy A:Objective response rate RECIST 1.1
Substudy B: Number and severity of adverse events
Substudy B: To facilitate continued treatment with durvalumab (=/- Tremelimumab) for patients currently enrolled on completed CCTG trials

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

Cohort 2: Standard Risk - Arm B
1 of 3
Cohort 2: Standard Risk - Arm A
1 of 3
Cohort 1: High Risk
1 of 3
Active Control

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment 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 2 and have already been tested with other people.

Cohort 2: Standard Risk - Arm B
Drug
Cohort 2: Standard Risk - Arm A
Cohort 1: High Risk

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Saskatoon Cancer Centre - Saskatoon, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Malignancies. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have a solid tumour, advanced/ metastatic/recurrent or unresectable. show original
Patients must live within Canada and have received duvalumab alone, or durvalumab in combination with tremelimumab, with or without chemotherapy/targeted therapy. show original
You have previously discontinued immunotherapy due to an irAE. show original
Immune related adverse event must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least 28 days prior to registration in this current study.
Complete response, partial response or prolonged stable disease (SD ≥ 8 weeks) to initial immunotherapy. Patients that received prior adjuvant/neoadjuvant/consolidation immunotherapy are eligible providing there has been at least a 6 month treatment free interval prior to enrollment and patient has received at least one standard of care chemotherapy regimen in the palliative setting (discuss with CCTG if chemotherapy is not considered standard of care or not indicated or patient refused/not eligible as such patients are eligible).
You have a life expectancy of at least 12 weeks. show original
Tumour material may have already been submitted to CCTG for the initial trial. If an additional formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) is available from tissue collected after immunotherapy discontinuation, patients must have provided informed consent for the release of the block. All patients must have provided informed consent for correlative studies. If patients from non-CCTG trials or commercial use are eventually enrolled, tumour material is also required if available, preferably from tissue collected after immunotherapy discontinuation.
You have or will have a disease that can be measured by clinical or radiologic means. show original
You have a good performance status (0 or 1). show original
Previous Therapy

Patient Q&A Section

What is malignancies?

"Malignancies typically have a rapid growth in numbers, have the ability to spread to new tissue, and rarely have the ability to heal without any treatment." - Anonymous Online Contributor

Unverified Answer

How many people get malignancies a year in the United States?

"The American Cancer Society estimates that 56,780 new diagnoses of non-melanoma [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer)s will be made in 2007. This is an estimated 4.6% of the U.S. population. Among the most common malignancies, lung and prostate cancers, and melanoma showed very high incidence rates in all age groups; however the American Cancer Society did not calculate an incidence estimate for colorectal cancer, breast cancer, stomach cancer, or pancreatic cancer." - Anonymous Online Contributor

Unverified Answer

What causes malignancies?

"The cause of malignancies may be influenced by the physical environment in which they develop. Tobacco, diet, exposure to occupational exposures to carcinogens (e.g., asbestos, benzopyrene, lead, ultraviolet radiation and others), and infections with oncogenic viruses may be important environmental factors. Some of these factors are more important than others. The mechanism by which such factors cause the malignancy often may be dependent on the immune system. As malignancies are commonly associated with immunosuppression or the use of immunosuppressive medications such as corticosteroids, they are not always the causative agent of the malignancy." - Anonymous Online Contributor

Unverified Answer

Can malignancies be cured?

"The concept of cure appears ambiguous when associated with malignant disease. It is unclear whether some subtypes of cancer can be cured or the cure is not feasible as long as a cure is not found for the disease. These observations encourage physicians and research researchers to focus their efforts on designing treatment plans that aim at providing symptomatic relief." - Anonymous Online Contributor

Unverified Answer

What are the signs of malignancies?

"The signs of malignancies include unusual appearance of the skin, change of vision, headache and abnormal behavior. The signs of malignancies may be not evident but are very important when they occur." - Anonymous Online Contributor

Unverified Answer

What are common treatments for malignancies?

"Symptoms and complications typically arise from the underlying cancer and can result from treatment. Treatment of cancer may include surgery, chemotherapy, radiation therapy, and targeted therapy. Surgery, specifically debulking, is typically performed by specialists. Treatment of malignancies can be tailored to a patient depending on their stage of progression. Adjuvant treatment can be used to reduce progression of the cancer to metastases. Targeted treatment uses drugs or treatments specifically directed at the tumor in the hopes that it will decrease tumor growth and lead to fewer side effects and higher remission rates. Chemotherapy often provides temporary relief and is rarely used alone. Antipsychotics are effective in treating mood irregularities in schizophrenia." - Anonymous Online Contributor

Unverified Answer

What is the latest research for malignancies?

"Although survival rates have improved for brain tumors in recent years, our knowledge of the biology of brain tumors remains limited. Many of the current therapies used to treat brain cancer may have been developed for other diseases or for other organs including the brain." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"Targeted therapies are proving effective and safe in a variety of cancer types. The high level of activity of the EGFR (EGFR inhibitor afatinib) and of Her2/neu (trastuzumab), as well as the high response rate to trastuzumab in Her2/neu-containing tumors, warrant exploration of the use of targeted therapy in patients with HER2/neu-expressing breast cancer." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The common side effects of treatment include fatigue, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, rash, itch, and joint pain. These common side effects should be evaluated by the patient before treatment. The clinician should be aware of these side effects and ask patients to report any side effects that are unexplained. All side effects should be evaluated by a medical professional for diagnosis." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with malignancies?

"In this sample, most patients reported improvements in quality of life as a result of their illness and treatment. Future directions should involve assessing psychological and social variables when addressing quality of life for patients. Clinicians can incorporate patient perceptions and expectations into their clinical decision-making and treatment plans to aid in improving quality of life and treatment outcomes." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Few patients received treatment in combination with any treatments other than radiotherapy. Treatment typically used in combination with radiotherapy was more commonly used than combination chemotherapy. The use of radiotherapy or radiation sensitization techniques had little influence on the use of chemotherapy and no influence on the use of radical radiotherapy only." - Anonymous Online Contributor

Unverified Answer

How serious can malignancies be?

"Most people will have a malignancy at some point in their life. Physicians are often not sure what to expect when a malignancy develops. To facilitate patient education, we have developed guidelines for patients with non-Hodgkin lymphoma, [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), cancer of the skin, and lung cancer. Physicians can use patients' medical records to review their illness and treatment, and patients can review their medical records themselves to obtain copies of their records. Our guidelines assist in informing patients from the very early stages of a malignancy until a cancer is definitively treated." - Anonymous Online Contributor

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