CLINICAL TRIAL

Edodekin alfa for Cancer

Metastatic
Recruiting · 18+ · All Sexes · San Antonio, TX

This study is evaluating whether a combination of two immunotherapy drugs may help treat solid tumors.

See full description

About the trial for Cancer

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

Treatment Groups

This trial involves 2 different treatments. Edodekin Alfa 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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab
BIOLOGICAL
Edodekin alfa
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. 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:
Age >= 18 years
Because no dosing or adverse event data are currently available on the use of pembrolizumab (MK-3475) in combination with rhIL-12 in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Life expectancy of greater than 12 weeks
Leukocytes >= 2,000/mcL (within 28 days of treatment initiation)
Absolute neutrophil count >= 1,500/mcL (within 28 days of treatment initiation)
Hemoglobin >= 9 g/dL OR >= 5.6 mmol/L (within 28 days of treatment initiation)
You have histologically confirmed malignancy that is metastatic or unresectable. show original
You are eligible if you have a tumor for which anti-PD(L)1 therapy is indicated; and have progressed past anti-PD(L)1 singly or in combination. show original
You have a platelet count of at least 100,000/mcL within 28 days of treatment initiation. 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 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
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 Edodekin alfa will improve 2 primary outcomes, 4 secondary outcomes, and 1 other outcome in patients with Cancer. Measurement will happen over the course of Up to 2 cycles of treatment.

CD8+ T cell infiltration
UP TO 2 CYCLES OF TREATMENT
Will be assessed by immunohistochemistry. Will be compared to pre-treatment biopsy specimens by the Wilcoxon signed-rank test.
UP TO 2 CYCLES OF TREATMENT
Incidence of adverse events
UP TO 30 DAYS AFTER LAST DOSE
Adverse events will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade, CTCAE category, relatedness to treatment and dose level.
UP TO 30 DAYS AFTER LAST DOSE
Overall response rate
FROM START OF TREATMENT UNTIL DISEASE PROGRESSION/RECURRENCE ((TAKING AS REFERENCE FOR PROGRESSIVE DISEASE THE SMALLEST MEASUREMENTS RECORDED SINCE THE TREATMENT STARTED), ASSESSED UP TO 5 YEARS
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. The proportion of patients experiencing confirmed overall (complete or partial) response will be calculated, as will a 95% exact (Klopper-Pearson) binomial confidence interval for all patients, and patients treated at the MTD (a confirmed clinical tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least >= 4 weeks apart.).
FROM START OF TREATMENT UNTIL DISEASE PROGRESSION/RECURRENCE ((TAKING AS REFERENCE FOR PROGRESSIVE DISEASE THE SMALLEST MEASUREMENTS RECORDED SINCE THE TREATMENT STARTED), ASSESSED UP TO 5 YEARS
Progression free survival
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER COMES, FIRST ASSESSED UP TO 5 YEARS
The product-limit (Kaplan-Meier) progression-free survival function, with a 95% confidence region, will be determined for all patients and for patients treated at the MTD.
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER COMES, FIRST ASSESSED UP TO 5 YEARS
Biomarker analysis
UP TO 5 YEARS
Will conduct exploratory translational laboratory correlative studies utilizing banked biospecimens (tumor, blood and stool) obtained at baseline and during therapy.
UP TO 5 YEARS
Recommended phase 2 dose
UP TO 5 YEARS
UP TO 5 YEARS
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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 does edodekin alfa usually treat?

Edodekin alfa is an effective treatment for advanced/metastatic NSCLC/SCLC and metastatic breast cancer. The treatment has also shown to be effective vs other chemotherapy for early-stage malignancies. Adverse events are not anticipated in patients receiving edodekin alfa and are mild to moderate.

Anonymous Patient Answer

What is cancer?

Most individuals at high risk of cancer are unlikely to receive any indication to be tested. This could be due to insufficient knowledge that some tests are indicated, lack of awareness of tests, incorrect beliefs, or lack of willingness due to fear for their test results.

Anonymous Patient Answer

What are the signs of cancer?

There are several signs which can occur before and during the growth phase of cancer, as well as after cancer has started. There are four stages of the cancer, one of which is cancer in its earliest stages; stage I. These signs are not always present at the same time in different people. However, they are very common, since they are easily accessible to a physician. The signs are often present even in asymptomatic cases; such cases do not require treatment unless the person is experiencing problems because of the disease.

Anonymous Patient Answer

What are common treatments for cancer?

Treatments and treatment options may vary according to one's particular cancer type. Treatment for non-small cell lung cancer may include anti-cancer treatment, surgery, and radiation therapy. When it comes to other types of cancers, treatment may include surgery and medications.

Anonymous Patient Answer

Can cancer be cured?

There is no strong evidence to support the assertion that cancer can be cured. It is a difficult disease, for which there unfortunately are no proven curative therapies. Nevertheless, a large number of treatments prolong survival, and may prevent further progression of disease.

Anonymous Patient Answer

What causes cancer?

There is conflicting evidence concerning the causes of cancer and cancer is likely the result of complex interactions between genetics, environment, and other factors. Cancer is the result of genetic mutations in cells that then cause cancerous transformation.

Anonymous Patient Answer

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

There could be around 80,000 new cases of cancer in the United States if all people got screened every year. The numbers may be higher, depending on data collected in various settings, because most of the surveillance is done only in those most likely to have been at risk. These numbers show that the current detection paradigm needs to be augmented. Although data from the general population are necessary for tracking change over time, information from specific disease settings may be necessary to provide accurate estimates of numbers of new cancers diagnosed.

Anonymous Patient Answer

What is the primary cause of cancer?

It is an important matter for physicians to determine the primary cause of cancer. The primary cancer of more than 90% of patients with cancer is related to environmental exposures. This is especially so in cases of bladder cancer and lung cancer, where exposure to tobacco, and secondarily to asbestos, are known as the major causes of these cancers.

Anonymous Patient Answer

How does edodekin alfa work?

Edodekin alfa is well tolerated, and most patients experienced clinically relevant symptoms of rheumatoid disease alleviation within 3 months. The improvement of disease activity was clinically relevant.

Anonymous Patient Answer

Is edodekin alfa safe for people?

Edodicin alfa is safe for people with CLL/SLL at any stage of the disease, including those in the long term following a successful treatment with ruxolitinib. However, it cannot be used for people with CLL/SLL on the basis of an uncontrolled study. Therefore, further trials with long term follow-up are required.

Anonymous Patient Answer

How serious can cancer be?

There are certain clinical markers, such as CEA, and also pathological examination can indicate how the cancer is progressing. Because most people with cancer can survive cancer, they are not in need of life-sustaining treatment. Most people with a serious illness, however, can survive, but the quality of life is reduced. There is no reason to prolong life when the person is not in good health. It is important to know the importance of the life-sustaining treatment to ensure the quality of life will be improved.

Anonymous Patient Answer

Is edodekin alfa typically used in combination with any other treatments?

Edodekin alfa is occasionally used in combination with other treatments. Inclusion of some other treatments in patients who are eligible for edodekin alfa should be questioned; clinicians should be alert about possible combinations with other agents when considering the use of edodekin alfa.

Anonymous Patient Answer
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