CLINICAL TRIAL

V937 for Neoplasm Metastasis

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · Lisbon, Portugal

This study is evaluating whether a combination of two drugs may help treat cancer.

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About the trial for Neoplasm Metastasis

Treatment Groups

This trial involves 8 different treatments. V937 is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
V937
BIOLOGICAL
+
Pembrolizumab
DRUG
Experimental Group 2
V937
BIOLOGICAL
+
Pembrolizumab
DRUG
Experimental Group 3
V937
BIOLOGICAL
+
Pembrolizumab
DRUG
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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. You must have received 1 prior treatment for Neoplasm Metastasis. 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:
Locally-advanced disease that is not amenable to surgery or radiation, or Stage IV advanced/metastatic solid tumor malignancies
Histologically- or cytologically-confirmed diagnosis of an advanced/metastatic solid tumor.
Measurable disease by RECIST 1.1 criteria as assessed by investigator. Target lesions in a previously irradiated area will be considered measurable if progression has been demonstrated in such lesions
Is a WOCBP and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention.
Submitted a baseline tumor sample for analysis. Participants enrolling in Part 2 Cohorts D-F may enroll without submitting a tumor sample if all other enrollment criteria are met.
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale obtained within 72 hours prior to the first dose of study intervention
If participant has known human immunodeficiency virus (HIV)-positive disease, participant must have well-controlled HIV on antiretroviral therapy (ART), per study criteria.
Adequate organ function
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 120 days: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR must agree to use contraception unless confirmed to be azoospermic.
Is not a woman of childbearing potential (WOCBP)
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to approximately 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to approximately 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to approximately 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 V937 will improve 4 primary outcomes and 9 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of Up to approximately 4 weeks.

Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
UP TO APPROXIMATELY 4 WEEKS
DLTs are defined as toxicities that: are possibly, probably, or definitely related to study intervention administration; and meet pre-defined study criteria.
UP TO APPROXIMATELY 4 WEEKS
Part 2: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
UP TO APPROXIMATELY 103 WEEKS
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Only the Part 2 arms will be analyzed in this outcome measure.
UP TO APPROXIMATELY 103 WEEKS
Part 1: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
UP TO APPROXIMATELY 103 WEEKS
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Only the Part 1 arms will be analyzed in this outcome measure.
UP TO APPROXIMATELY 103 WEEKS
Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
UP TO APPROXIMATELY 107 WEEKS
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Only the Part 1 arms will be analyzed in this outcome measure.
UP TO APPROXIMATELY 107 WEEKS
Part 2: Number of Participants Who Experienced One or More Adverse Events (AEs)
UP TO APPROXIMATELY 107 WEEKS
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Only the Part 2 arms will be analyzed in this outcome measure.
UP TO APPROXIMATELY 107 WEEKS
Part 1: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator
UP TO APPROXIMATELY 5 YEARS
ORR is defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Only the Part 1 arms will be analyzed in this outcome measure.
UP TO APPROXIMATELY 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 is neoplasm metastasis?

Neoplasm metastasis is the establishment of distant tumors by cancer cells from one neoplasm that have escaped primary tumor control. The exact pathogenesis of neoplasm metastasis has still not been fully understood. The development of new agents to prevent metastasis, and agents to treat metastatic tumor sites are discussed.

Anonymous Patient Answer

What are the signs of neoplasm metastasis?

The following symptoms may be considered as suggestive signs of impending neoplasmal metastasis; pain in the bones, joints or other parts of the body; coughing up blood; and swollen lymph nodes in the axillary, inguinal, and groin areas.

Anonymous Patient Answer

How many people get neoplasm metastasis a year in the United States?

A significant percentage of the population presents with metastatic neoplasm, with a high percentage of malignant tumors in different regions of the body. The number of people who get neoplasm metastasis is greater for the southern and eastern regions of the United States.

Anonymous Patient Answer

What causes neoplasm metastasis?

The cause of neoplasm metastasis is still uncertain. But it could be associated with genetic, immunological, and inflammatory factors. Neoplasm metastasis also is related to metastasis of primary tumors, which occur in the same person.

Anonymous Patient Answer

What are common treatments for neoplasm metastasis?

When neoplasms are metastasized to the thoracic, abdominal, or pelvic viscera, chemotherapy is always used, but chemotherapy is not always used to treat the neoplasm. Local irradiation can be employed in certain cases. For patients who have bone, bone marrow or liver metastases, palliative treatment is more frequent than treatment to eradicate metastases by surgery.

Anonymous Patient Answer

Can neoplasm metastasis be cured?

The current study was able to show that metastastic lesions can be eliminated, even after metastasis. However, metastatic lesions were found to be resistant to a chemotherapy using vincristine and doxorubicin for at least a month.

Anonymous Patient Answer

What is the latest research for neoplasm metastasis?

The incidence of metastasis is increasing. However, prognosis remains poor. Most metastatic neoplasms are hormone-sensitive cancers such as breast carcinoma, prostate carcinoma, and gonadal carcinoma. More efforts are needed in the advancement of gene therapy. The application of chemotherapeutic drugs in combination with gene therapy should be encouraged. In addition, more randomized clinical controlled trials are indispensable and should be performed to improve the prognosis of metastatic neoplasm.

Anonymous Patient Answer

Who should consider clinical trials for neoplasm metastasis?

Neoplasm metastasis trials (and other rare cancers) are under-represented in the literature. As such, clinicians faced with metastatic solid tumors need to consider treatment options based on the most up-to-date information and, more importantly, understand the risks and benefits of the specific treatment options available to them.

Anonymous Patient Answer

Has v937 proven to be more effective than a placebo?

The use of PEP-S was found to be more effective than a placebo for the treatment of recurrent vulvar cancer. The use of PEP-S should be considered in recurrent vulvar premalignancy and dysplasia patients with vulvar neoplasms. PEP-S is effective in reducing lesions of the vaginal vault with histologic evidence of residual disease and neoplastic keratinization of the intraepithelial lining of the vagina. The use of PEP-S should be considered in all women with a history of recurrent vulvar malignancies.

Anonymous Patient Answer

Does neoplasm metastasis run in families?

Based on the results of this large-scale, multi-center study, no significant differences in metastasis occurrence in non-familial and familial neoplasm cases were found. Thus the results of our study do not support any influence of the familial on the occurrence of neoplasm metastasis.

Anonymous Patient Answer

What does v937 usually treat?

The study reported here gives an overview on the current status of therapeutic intervention against v937. The data also illustrates the need to standardize the diagnostic criteria as well as the definition of 'effective/therapeutic concentration' in future trials in order to avoid a large array of different conclusions.

Anonymous Patient Answer

What is the survival rate for neoplasm metastasis?

Survival rates of metastatic disease are dependent on a patient's initial tumor type, stage, and treatment regimen. Metastases from many types of primary tumors have a very high survival rate, and they can become malignant, albeit rarely. The median prognoses for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), colorectal cancer, and oesophageal cancer are around five to seven years, whereas those for other types are typically less than two years.

Anonymous Patient Answer
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