CLINICAL TRIAL

Durvalumab for Cancer

Recruiting · 18+ · All Sexes · Bethesda, MD

This study is evaluating the side effects of durvalumab when given together with chemotherapy in treating patients with solid tumors that have spread to others places in the body (advanced).

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About the trial for Cancer

Eligible Conditions
Unresectable Malignant Solid Neoplasm · Neoplasms · Metastatic Malignant Solid Neoplasm · Locally Advanced Malignant Solid Neoplasm

Treatment Groups

This trial involves 7 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Paclitaxel
DRUG
+
Durvalumab
BIOLOGICAL
Experimental Group 2
Gemcitabine Hydrochloride
DRUG
+
Durvalumab
BIOLOGICAL
Experimental Group 3
Durvalumab
BIOLOGICAL
+
Nab-paclitaxel
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Doxorubicin
FDA approved
Carboplatin
FDA approved
Gemcitabine
FDA approved
Durvalumab
FDA approved
Capecitabine
FDA approved
Paclitaxel
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
This patient must have a tumor that can be biopsied and must be willing to have a tumor biopsy. show original
People who have tumors that have spread to other parts of the body (metastatic) or who have tumors that are difficult to remove surgically (locally advanced) and whose disease has progressed after at least one round of standard treatment, or for which no standard treatment exists that has been shown to prolong survival. show original
Patients with bone metastases or hypercalcemia who are being treated with intravenous bisphosphonates, denosumab, or similar agents are eligible to participate show original
If anti-PD-1 or one of the 6 chemotherapy agents is standard-of-care, patients would not need to have prior therapy with the agent. show original
If you have collected tissue as part of another study or from a procedure performed due to medical necessity within the last 3 months, it may be acceptable as the baseline sample for this study show original
The patient has a performance status of less than or equal to 2, which is considered to be a good prognosis. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 months after the last dose of study drug
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 months after the last dose of study drug.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 3 other outcomes in patients with Cancer. Measurement will happen over the course of Up to 2 cycles (Arms 1-3) or 4 cycles Arms (4-7).

Incidence of adverse events
UP TO 2 CYCLES (ARMS 1-3) OR 4 CYCLES ARMS (4-7)
Immunotherapy response of tumor-infiltrating and circulating T cells
UP TO 3 MONTHS AFTER THE LAST DOSE OF STUDY DRUG
Will investigate whether the response to immunotherapy correlates with patients' genetic aberrations and/or the activation status of tumor-infiltrating and circulating T cells.
Immune status of the tumor and overall tumor mutational load
UP TO 3 MONTHS AFTER THE LAST DOSE OF STUDY DRUG
Will explore the relationship between immune status of the tumor and overall tumor mutational load.
Changes in the immune microenvironment
BASELINE UP TO 3 MONTHS AFTER THE LAST DOSE OF STUDY DRUG
Will assess how these changes alter the pharmacodynamic effects of a checkpoint inhibitor.

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 causes cancer?

Data from a recent study shows that environmental factors alone are not sufficient to cause cancer. Cancer is a complex disease, and it requires a wide spectrum of factors. Tobacco smoking is an important environmental factor. Further research is needed to identify environmental factors that contribute to cancer.

Anonymous Patient Answer

Can cancer be cured?

Cancer cannot be cured. Symptoms can sometimes be decreased, and the patient can sometimes live independently, but that's not enough. The disease tends to come back.

Anonymous Patient Answer

What are common treatments for cancer?

Several different options are available for the management of cancer, including surgery and chemotherapy. Some cancers, such as most brain cancers, require surgical removal. Chemotherapy is typically used in more serious cancers, some types of melanoma and certain types of lymphoma. A variety of treatments are available, including the use of biological medications to prevent or treat cancer. Treatment decisions will depend on the stage of the cancer and any signs or symptoms that may interfere with normal daily activities.\n

Anonymous Patient Answer

What are the signs of cancer?

This is one of the few signs related specifically to cancer. Tumor markers such as a rising number indicate cancer, whereas a constant number (especially if it is over three) could be a symptom.\n\nThe signs of illness in patients can be divided into symptoms and signs and can be associated with a particular type of organ in the body, for example bone, heart, lung. The signs and symptoms can be subdivided into major and minor ones. Minor ones are related to a particular organ.\n\nSigns of bone disease can be divided into osteopenia and osteopathy.

Anonymous Patient Answer

What is cancer?

Cancer has always been a major source of death, misery and suffering in many cultures across the globe. It had been defined as the “fever” in 1393 by Mondino de Luzzi. The disease is not limited to just “the big three” – it affects every age groups. Cancer kills more than 20 million people globally annually and is a major global public health concern.

Anonymous Patient Answer

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

Around 300,000 cases of cancer are diagnosed a year in the United States. Lung cancer is the most common type of cancer diagnosed (27%), and colon cancer is the second most common (20.4%). Most cancer diagnoses are non-progressive (83%).

Anonymous Patient Answer

How serious can cancer be?

Cancer is a devastating disease. On the whole, though, the prognosis is good, which is what I thought I knew about cancer. I guess I was mistaken in my conclusions. The most devastating thing about being diagnosed with cancer is the sense of helplessness that overwhelms you. In all honesty, the worst part of the experience is when you do nothing to cope with this sense of dread. You cannot stop the cancer's advances, you cannot stop the weight loss, you can’t stop the pain, the nausea, the lack of coordination, the loss of your life's meaning. But once you start treatment, the disease is beat back.

Anonymous Patient Answer

What is the average age someone gets cancer?

For most people cancer is the first illness or chronic disease — a symptom, like headaches or stomachache — when they begin to age. The average age of cancer diagnoses increases with age, but not because there is a trend towards earlier diagnosis as people age — there is a substantial age bias in the diagnoses. This bias is the main reason cancer statistics are so low in youth and middle age, and are higher at age 75 and thereafter. In all age groups, the proportion of cancers diagnosed at age zero increased significantly between 1992 and 2002, but age-adjusted cancer incidence declined over the same period.

Anonymous Patient Answer

Has durvalumab proven to be more effective than a placebo?

In a recent study, findings suggest that PD-L1 inhibition is generally ineffective in advanced non-small-cell lung cancer (NSCLC) with mutant epidermal growth factor receptor (EGFR) or ALK-positive.

Anonymous Patient Answer

Who should consider clinical trials for cancer?

The present study did not find any strong or statistically significant association between family background and consent rate, but one could not exclude the possibility of interaction between other variables, such as ethnicity. More research is needed to understand why a minority group may be at a disadvantage in clinical trials, in terms of their consent rate and drop-out rate.

Anonymous Patient Answer

Is durvalumab typically used in combination with any other treatments?

Durvalumab is more frequently used as a second-line therapy in combination with other anticancer therapies, rather than as a single agent. However, a substantial number of patients have only a small or no effect from combination therapy.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

We found that over 90% of new therapies were developed within the last 20 years and had not been available to patients in the past 20 years. A review of the current evidence and practice suggests there is a need to ensure that innovative approaches to the treatment of cancer are prioritised. However, the identification of unmet clinical needs still remains an important factor when designing clinical trials.

Anonymous Patient Answer
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