CLINICAL TRIAL

DPX-Survivac for Fallopian Tube Cancer

Locally Advanced
Recruiting · 18+ · Female · Toronto, Canada

This study is evaluating whether a combination of a vaccine, a drug and a low dose of chemotherapy has anti-tumor activity in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

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About the trial for Fallopian Tube Cancer

Eligible Conditions
Cancer, Advanced · Primary Peritoneal Carcinoma · Ovarian Cancer · Fallopian Tube Neoplasms · Fallopian Tubes Cancer

Treatment Groups

This trial involves 4 different treatments. DPX-Survivac is the primary treatment being studied. Participants will be divided into 4 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
Cyclophosphamide
DRUG
+
Pembrolizumab
DRUG
+
DPX-Survivac
BIOLOGICAL
Experimental Group 2
Cyclophosphamide
DRUG
+
Pembrolizumab
DRUG
+
DPX-Survivac
BIOLOGICAL
Experimental Group 3
Cyclophosphamide
DRUG
+
Pembrolizumab
DRUG
+
DPX-Survivac
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Pembrolizumab
FDA approved
DPX-Survivac
2013
Completed Phase 1
~60

Eligibility

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Have fulfilled the following additional requirements regarding prior treatments depending on the cohort that the patient is to be enrolled in.
Eastern Cooperative Group (ECOG) performance status <=1.
Life expectancy greater than 16 weeks.
Patients must have histologically or cytologically confirmed advanced epithelial ovarian, primary peritoneal or fallopian tube carcinomas.
Patients must have radiologically documented disease progression from their prior line of therapy.
Patients must have measurable disease based on RECIST 1.1.
Have received a front line platinum-based regimen (administered via either IV or IP) following primary or interval debulking surgery with documented disease recurrence.
Availability of archival tumor tissue samples. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the laboratory.
Be willing to provide tumor tissue from a newly obtained core or excisional biopsy prior to start treatment and on day 15 of cycle 1.
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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: 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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 DPX-Survivac will improve 1 primary outcome and 3 secondary outcomes in patients with Fallopian Tube Cancer. Measurement will happen over the course of 5 years.

Overall survival (OS) rate
5 YEARS
OS rate from start of study treatment until death for every cause
5 YEARS
Number of side effects
5 YEARS
Adverse events will be analyzed as safety parameters
5 YEARS
Progression free survival (PFS) rate
5 YEARS
PFS rate from start of study treatment to time of progression or death whichever comes first
5 YEARS
Overall response rate (ORR)
5 YEARS
ORR will be used to evaluate the clinical anti-tumor activity of Pembrolizumab, DPX Survivac and oral cyclophosphamide combination.
5 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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

Approximately 43,000 fallopian tube cancer cases were diagnosed in the US in 2011. Among fallopian tube cancer patients, younger age, black gender and the presence of family history are associated with advanced disease at time of presentation.

Anonymous Patient Answer

What causes fallopian tube cancer?

It has been demonstrated that the main germ line cancer susceptibility mutations in BRCA2 and BRCA1 confer an increased risk of developing epithelial ovarian cancer as well as fallopian tube cancer. Although the precise mechanism by which BRCA1/2 causes ovarian cancer is unknown, fallopian tube cancer is thought to result from a malfunction in cells or genes involved in genomic stability.

Anonymous Patient Answer

What are common treatments for fallopian tube cancer?

There is no cure for Fallopian cancers. Their management is highly dependent on the surgical treatment and chemotherapy used. As a result, management of Fallopian tubes is primarily symptomatic. Treatment may include chemotherapy and surgery.

Anonymous Patient Answer

What is fallopian tube cancer?

Complications are observed in most of patients undergoing surgery of the ovary and fallopian tube. One out of ten of patients develop ovarian cancer later in life and 5% of these patients are diagnosed on the fallopian tube.

Anonymous Patient Answer

What are the signs of fallopian tube cancer?

Fallopian tube cancer can present with the above signs of other gynecological cancers. It arises from ectopic endometrial-type tissue in the fallopian tube, but the signs of the disease are not as characteristic as in ovarian cancer.

Anonymous Patient Answer

Does dpx-survivac improve quality of life for those with fallopian tube cancer?

Patient reported health status, as well as QOL (objective), improved following a trial of Dpx-survivac. The improvement in patient QOL appeared to continue at 12-month follow-up. Randomized controlled trials of a single agent with an evidence base for treatment are a good way to demonstrate cost effectiveness for health care providers. Results from a recent paper support the continued investigation of Dpx-survivac as a treatment for fallopian tube cancer.

Anonymous Patient Answer

Is dpx-survivac typically used in combination with any other treatments?

Since there is no published evidence in the literature of the effectiveness or efficacy of DPX-SI-based combinations involving other common or novel treatments, more rigorous, randomized, and controlled trials are needed to assess the effectiveness and efficacy of these treatments. The use of DPX-SI-based mixtures on its own, irrespective of combination strategies, is probably not advisable for patients with FIGO stage I and II disease, since this treatment regimen should be used in combination with other more conventional treatment options.

Anonymous Patient Answer

What is dpx-survivac?

Dpx-survival is a reliable method for selecting women most likely to respond to the addition of gemcitabine to surgery in early stage serous epithelial ovarian cancer: it could be incorporated into clinical protocols. © 2016 John Wiley & Sons, Ltd.

Anonymous Patient Answer

Have there been other clinical trials involving dpx-survivac?

This was the first trial investigating dpx-survivac in treating patients with advanced ovarian cancer. Dpx-survivac did not significantly increase patient survival. Most of the patients had a progressive response to platinum, paclitaxel and/or ifosfamide-based treatment.

Anonymous Patient Answer

What are the chances of developing fallopian tube cancer?

Fallopian tube cancer is uncommon in women with HSD and usually manifests late and presents with advanced-stage disease at diagnosis. This information may be helpful in informing high-risk women about the potential burden of fallopian tube cancer and identifying high-priority areas for further research and screening to reduce the devastating impact of this disease in women with an HSD.

Anonymous Patient Answer

What is the primary cause of fallopian tube cancer?

Although the epidemiology and etiology of the disease is not completely understood, fallopian tube cancer is known to occur more frequently in women aged 40-48 years.

Anonymous Patient Answer
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