BNT162b2 vaccine for Malignancies

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Montefiore Medical Center, Bronx, NY
Malignancies
BNT162b2 vaccine - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a COVID vaccine booster is safe and effective in people with cancer.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether BNT162b2 vaccine will improve 1 primary outcome in patients with Malignancies. Measurement will happen over the course of 4 weeks after booster dose.

Week 4
Rates of seroconversion for SARS-CoV-2 spike antibody

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Booster dose
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. BNT162b2 Vaccine 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.

Booster dose
Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after booster dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 weeks after booster dose for reporting.

Closest Location

Montefiore Medical Center - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Above the age of 18
Known diagnosis of any malignancy- either active or completed therapy
Underwent an in-person encounter at a study facility during the study period
Have a negative SARS-CoV-2 spike IgG at least 14 days after the second dose of the mRNA-based vaccines (Moderna or Pfizer/BioNTech) or 28 days after a single dose of the adenovirus-based Johnson & Johnson vaccine.

Patient Q&A Section

Can malignancies be cured?

"The only method of curing a primary tumor is to remove it completely. No form of treatment can eradicate metastatic disease. With adequate medical therapy, some patients with metastatic cancer can live a normal life, even without medical therapy. However, there is no method for curing a metastatic primary cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of malignancies?

"The signs of cancer are often vague, vague enough to warrant the initiation of a thorough systemic examination. The signs may include lethargy/anemia/anorexia/weight loss. These are of particular concern in people with a recent history of malignancy. Screening the skin and the mucosa should be carried out at presentation as a more efficient investigation for detection of cancer than the blood-borne tests. Most of these signs are nonspecific including acute respiratory tract infections and dermatological and haematological complaints." - Anonymous Online Contributor

Unverified Answer

What is malignancies?

"There have been several approaches of classifying primary cancer in patients (pathotypes). A specific type of cancer cell type is often found in the primary tumor when compared to the corresponding metastasis. This new approach enables us to classify primary tumors in a more precise way, and aids in identifying the most appropriate therapeutic approach that will be the most likely to be effective in the specific cancer type. Because the primary cancer in most cases precedes its metastases which have a different phenotype, we propose now a new classification scheme based on the cellular origins of the various tumor types. The proposed scheme is based on cell-specific biomarkers and highlights the need to further define the biological basis for the classification of solid tumors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for malignancies?

"A variety of different therapies are used in the treatment of malignancies. The treatment of cancer is complicated by the fact that each person is unique in both their genetics and in how they process or react to treatment." - Anonymous Online Contributor

Unverified Answer

What causes malignancies?

"There are many known factors leading to malignant transformation of lung cancer cells and subsequent development of malignant lung cancer. These factors include genetics, environmental exposures, and viral and bacterial infections. All these factors may be modulated by immunological and metabolic defenses that are present in normal lung tissue, which may contribute to carcinogenesis. All these factors may also be modulated by tobacco smoking, which modulates the immune system and leads to the development of lung cancer. Smoking also has an effect on malignant transformation in lung cancer cells, leading to an upregulation of many proliferation and invasion-related genes and proteins in the smoking-induced lung cancer cells." - Anonymous Online Contributor

Unverified Answer

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

"This article discusses the common cancers diagnosed and reported annually in this country. These numbers are estimates and there should be some overreporting. More than 5 million people develop cancer a year in this country. There may be fewer than 5 million people each a year diagnosed with acute lymphocytic leukaemia, multiple myeloma and Ewing sarcoma. The statistics for cancer and malignancies are based on case history data and surveys of practicing pathologists. The data are not comparable and do not include information from all areas of medicine. The information may overestimate the numbers. There are several cancer registries working in this country. For more information, contact the Cancer Society of Alberta or the National Cancer Institute." - Anonymous Online Contributor

Unverified Answer

What is bnt162b2 vaccine?

"Varying routes of administration and schedules of administration were tested, but no conclusive evidence was found for bnt162b2's effectiveness at altering tumor growth rates in human and non-human primates. The U.S. Food and Drug Administration (FDA) currently does not support the concept behind using DNA vaccine based therapy to treat cancer. However, based on the available information discussed in this report, the U.S. Food and Drug Administration has concluded that there is potential for the development of novel therapies based on bnt162b2 that might not be eligible for approval by the FDA." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving bnt162b2 vaccine?

"Only one other clinical trial investigating bnt162b2 vaccine has been reported (https://clinicaltrials.gov) which focused on patients with metastatic [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer). The researchers suggested that [combining an immunotherapeutic vaccine with cytotoxic T-cells may present a better approach to cancer immunotherapy in general than using immunotherapy alone (http://clinicaltrials.gov)]. However, it is very difficult to compare the data from different clinical trials, because the protocols and conditions of different conditions are so different. Thus, it is not surprising that there is only one other reported trial. However, the treatment regimen in the other test might be considered to be different from the regimen used in this study." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating malignancies?

"Our group was unable to find new ways to cure any malignancies or treat any sub-types of cancers. If there are new breakthroughs, they are likely to be incremental because of the limited number of cancer treatments. We believe that these new treatment discoveries will be of limited application for future cancer treatments, especially in patients with cancer." - Anonymous Online Contributor

Unverified Answer

How serious can malignancies be?

"Results from a recent paper suggests the existence of a continuum between the seriousness of malignancies and their occurrence in people without apparent genetic predisposition. However, it is not possible to define a cut-off point for the seriousness of malignancies in this study. However, this is the first studies that have demonstrated an inverse relationship between prevalence of malignancies and seriousness in this population." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bnt162b2 vaccine?

"Bnt162b2 is an effective immunogenic oncogene-based viral vector with an excellent safety profile. Vaccine elicits sustained and systemic anti-tumor immunity in murine B16 melanoma model with minimal toxicity, and is highly promising for clinical development." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of malignancies?

"The data suggest that primary (i.e., etiologic) cancer develops from mutations and other genetic alterations. The most frequently occurring mutation in sporadic human cancer is transitions in TP53 that is frequently inactivated by promoter methylation. Tumors with these mutations in this gene can develop in several manners. The most frequent inactivation is by cytosine methylation. The other well-known gene is the oncogene BRCA1 (see Cancer genetics"

"Vriesea kunthii\n\nVriesea kunthii is a plant species in the genus "Vriesea". This species is endemic to Brazil." - 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.
See if you qualify for this trial
Get access to this novel treatment for Malignancies by sharing your contact details with the study coordinator.