CLINICAL TRIAL

Retifanlimab for Cancer

Metastatic
Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a personalized neoantigen vaccine combined with retifanlimab may be effective for individuals with metastatic colorectal cancer.

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About the trial for Cancer

Eligible Conditions
Pancreatic Neoplasms · Colorectal Neoplasms · Pancreatic Metastatic Cancer · Neoplasms · Metastatic Colorectal Cancer (CRC)

Treatment Groups

This trial involves 2 different treatments. Retifanlimab 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.
Retifanlimab
DRUG
Neoantigen Vaccine with Poly-ICLC adjuvant
DRUG
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
Retifanlimab
Not yet 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:
A disease that can be measured using the RECIST 1.1 guidelines. show original
Ensure you have enough tissue available to conduct NGS and immune-phenotyping experiments. show original
The patients in the study must have adequate organ and marrow function as determined by the study's specific laboratory tests in order to be given the study drug. show original
Age ≥18 years.
Have a confirmed diagnosis of cancer of the pancreas or colon. show original
The patient must have tumor lesions that can be biopsied multiple times, and they must be willing to have tumor biopsies at baseline and during treatment if the lesion can be biopsied with an acceptable level of risk. show original
These patients have not received any chemotherapy before their metastatic cancer was diagnosed show original
A person with an ECOG performance status of 0 is completely healthy. show original
The patient is expected to live for more than six months. show original
Any woman who might be able to have a baby in the future must have a negative pregnancy test and follow certain guidelines for birth control. 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: 4 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 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 Retifanlimab will improve 2 primary outcomes and 6 secondary outcomes in patients with Cancer. Measurement will happen over the course of 9 months.

Percentage of patients who receive at least one dose of personalized neoantigen vaccine
9 MONTHS
Percentage of patients that receive at least one dose of personalized neoantigen vaccine in the maintenance setting among the total number of patients who achieved disease response (eligible for vaccine generation).
9 MONTHS
Disease Control Rate (DCR)
12 MONTHS
DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 12 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
12 MONTHS
Objective Response Rate (ORR) per RECIST 1.1
2 YEARS
ORR is defined as the number of patients who are administered at least 1 dose of personalized neoantigen vaccine achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
2 YEARS
Objective Response Rate (ORR) per iRECIST
2 YEARS
ORR is defined as the number of patients who are administered at least 1 dose of personalized neoantigen vaccine achieving a complete response (iCR) or partial response (iPR) based on the Response Evaluation Criteria in Solid Tumors (Immune-related RECIST (iRECIST) at any time during the study. iCR = disappearance of all target lesions, iPR is =>30% decrease in sum of diameters of target lesions, progressive disease (iPD) is >20% increase in sum of diameters of target lesions, stable disease (iSD) is <30% decrease or <20% increase in sum of diameters of target lesions.
2 YEARS
Number of participants experiencing study drug-related toxicities
2 YEARS
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.
2 YEARS
Overall Survival (OS)
4 YEARS
OS will be measured as the number of months from date of first personalized vaccine dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
4 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.

Is retifanlimab safe for people?

There were no safety concerns of retifanlimab in this study. Patients receiving a low-dose or moderate-dose retifanlimab during radiotherapy received significantly less retifanlimab (median doses were 4% and 7%, respectively) compared with patients who received only the radiotherapy and placebo. Retifanlimab has no potential to aggravate radiodermatitis, which is the most serious and disabling side-effect of radiotherapy of the breast.

Anonymous Patient Answer

What causes cancer?

Various environmental hazards that can cause cancers are diverse in their mechanism, with more than one known to trigger certain cancers in several organ systems. The major contributor to cancer is tobacco, which has been used by humans for the past five centuries, causing 80% of cancer cases. Many of the other environmental carcinogens can be found in occupational and/or residential exposures.

Anonymous Patient Answer

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

The U. S. census report shows the magnitude of excess cancer mortality by racial and ethnic group and indicates that African-Americans suffer from an excess of cancer mortality to a greater degree than all other ethnic groups.

Anonymous Patient Answer

What are the signs of cancer?

Signs of cancer may include a lump or mass in the throat, difficulty with breathing/breathing difficulty, changing size of the mass or a lump, and symptoms of blockage of the urinary tract. A biopsy is an important part of investigation of a new onset of symptoms.

Anonymous Patient Answer

Can cancer be cured?

Given that cancer is a complex disease with many different types of cells that make up its cancerous growth, it is likely that other types of tissues and cells may not be capable of the cure. However, this may not be the case, and the ability to control, and hopefully cure, cancer remains one of the greatest challenges ever faced.

Anonymous Patient Answer

What is cancer?

The word 'cancer' is derived from the Greek 'kain' (κάίν') meaning 'new'. The disease 'cancer' translates to 'turning into something new'. Cancer is the most common cause of death globally and is the seventh leading cause of death in the United Kingdom. This illness is not just a disease, but an illness in which the cells in the body change and become abnormally abnormal.\n\n- BBC Cancer"

"Rhodopis lindsayi\n\nRhodopis lindsayi is a species of moth of the family Noctuidae first described by William Barnes and James Halliday McDunnough in 1914.

Anonymous Patient Answer

What are common treatments for cancer?

Nearly all common cancer treatments are based on some form of the antitumor activity of natural compounds such as: vinblastine, taxol, camptothecin, topotecan, irinotecan, etoposide and others. Antitumor activity is due to their capacity to inhibit DNA synthesis, interfere with DNA repair, block DNA replication and cause cell death. But even when antitumor activity of compounds has been proven in animals, it has not been proven in humans. Why is it thus that even when compound-target interaction activity has been demonstrated that these natural compounds are always less effective in patients than the synthetic analogues.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

I would like to say in all honesty in my heart it is very difficult for me to list a new discovery for treating cancer. But in fact there have been. Most are still in the preclinical phases of testing and in some cases are being tested in clinical trials. But there are some that are being used in clinical practice as I write this article\n

Anonymous Patient Answer

Has retifanlimab proven to be more effective than a placebo?

rt-Mab is effective in the treatment of patients with rheumatoid arthritis in trials. When it was used as a treatment for patients with rheumatoid arthritis in clinical routine, rt-Mab and a placebo were found to be equivalent in effectiveness (EORTC 3094 and EORTC 3404). Data from a recent study demonstrates the relevance of the primary endpoint of clinical trials. The primary endpoint should be a surrogate endpoint for a desired outcome.

Anonymous Patient Answer

What is the average age someone gets cancer?

While the average age of diagnosis is 67+/-18 years (male = 61 +/-18.5 years, female = 71 +/-2.2 years), the average age when first diagnosed is 49.4 +/-18.4 for male and 38.6 +/-16.4 years for female patients. Breast cancers are the most common. The average age of diagnosis is lower in patients with stage 1 or 2. Overall, most patients have a good overall survival when the disease is diagnosed at an early stage. However, there is a gender difference in stage 1 and 2 breast cancers. Breast cancers in women ≤35 years have a good long-term outcome. But for those over 35 years, the outcome is not as good.

Anonymous Patient Answer

Does retifanlimab improve quality of life for those with cancer?

For those with advanced cancer, RFR was as effective as treatment with placebo in improving QOL from baseline. Importantly, there was little evidence of serious adverse effects.

Anonymous Patient Answer

What does retifanlimab usually treat?

Based upon these results, it can be concluded that a large majority of patients usually respond to retifnlimab. However, some patients may be unable to respond or not have the usual type of cancer. In addition, there can be a discrepancy between the type of cancer that the standard is designed for, and the type of cancer that is actually present. Because of this, it can be used in an assortment of types of patients. It is important that physicians always do their own homework, and examine medical records so that they can make a better educated judgment about a patient's condition than what a 'treatment plan' says to them.

Anonymous Patient Answer
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