CLINICAL TRIAL

Pembrolizumab for Fallopian Tube Cancer

Waitlist Available · 18+ · Female · Boston, MA

This study is evaluating whether a combination of chemotherapy and immunotherapy might be a better treatment for ovarian cancer.

See full description

About the trial for Fallopian Tube Cancer

Eligible Conditions
Ovarian Cancer · Fallopian Tube Neoplasms · Fallopian Tubes Cancer · Ovarian Neoplasms · Malignant Peritoneal Neoplasm · Peritoneal Neoplasms

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab
DRUG
Pegylated Liposomal Doxorubicin (PLD)
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
Pembrolizumab
FDA approved
Doxorubicin
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Fallopian Tube Cancer or one of the other 5 conditions listed above. 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:
What this means is that you have a tumor that can be measured using the RECIST 1.1 criteria. show original
Candidates must have a confirmed diagnosis of epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer show original
To be a patient in the study, you must have had one prior platinum-based chemotherapy treatment that contained carboplatin, cisplatin, or another organoplatinum compound show original
This trial is for patients with platinum resistant cancer who have had a platinum free interval of less than six months show original
Patients are allowed to receive up to two additional cytotoxic regimens for management of recurrent or persistent disease show original
Patients are allowed to receive, but are not required to receive, PARP inhibitors as part of their primary treatment regimen. show original
Have a performance status of ECOG Performance Scale 0 or 1. show original
View All
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: 24 Months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 Months.
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 Pembrolizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Fallopian Tube Cancer. Measurement will happen over the course of 24 weeks.

Safety of the Combination of Pembrolizumab/PLD
24 WEEKS
Safety is measured by any dose limiting toxicity experienced within the safety lead in group of 6 patients. If 2 out of the first 6 patients develop a DLT, the dose of PLD will be reduced to 30 mg/m2. If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD), an additional 20 patients will be enrolled to complete the phase II study.
Progression-Free Survival [PFS]
24 WEEKS
Progression-Free Survival is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without progression are censored at date of last disease evaluation.
Clinical Benefit Rate [CBR]
24 WEEKS
The primary objective was to determine the CBR (complete response [CR] + partial response [PR] + stable disease [SD] >/= 24 weeks) of the combination of pembrolizumab and PLD.
Overall Survival
24 MONTHS
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Duration of Response [DOR]
24 MONTHS
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Overall Response Rate [ORR]
24 MONTHS
A secondary objective was to determine the Overall Response Rate [ORR] of the combination of pembrolizumab and PLD as defined by the number of participants achieving a partial response [PR] or complete response [CR].

Who is running the study

Principal Investigator
U. A. M.
Ursula A. Matulonis, MD
Dana-Farber Cancer Institute

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?

Overall, [Fallopian tube cancer incidence rates were higher than expected] and the number of Fallopian tube cancer cases was higher than reported previously and the percentage of cases attributable to known risk factors was much lower. Although the exact number of Fallopian tube cancer cases in women is uncertain, estimates range from 25,000 to 50,000 annually in the United States. The proportion of Fallopian tube cancer cases attributable to known risk factors is estimated to be less than 50% (range, 34-66%). Results from a recent paper underscore the importance of surveillance and surveillance, including the use of new, rapid, and inexpensive approaches, for addressing this disease.

Anonymous Patient Answer

Can fallopian tube cancer be cured?

Fallopian tube cancer cannot be cured and its disease-free survival is extremely short. Survival of fallopian tube cancer in the United States is less than 10% at 5 years.

Anonymous Patient Answer

What are common treatments for fallopian tube cancer?

Treatment for fallopian tube cancer is highly individualized and depends on a variety of factors. In the majority of patients with cancer of the fallopian tube, surgery and/or radiation therapy are used. As of 2007, adjunctive surgery should be considered an option.

Anonymous Patient Answer

What causes fallopian tube cancer?

Fallopian tube cancer has a number of risk factors which are mostly unknown or only poorly understood. They include smoking, age, overweight and not observing the correct method of contraception. While the cancer occurs it often does not lead to death or infertility, but it does impede the ability of the person to become pregnant. More research is needed to clarify these factors.

Anonymous Patient Answer

What are the signs of fallopian tube cancer?

Signs of fallopian-tube cancer may include a mass felt as enlarged breasts or as deep, unilateral pain in the abdomen or pelvis. The most common sign of malignancy is infertility. Most women are diagnosed after they have consulted other physicians. In these women, treatment is often delayed and the chance of cure low. It is imperative that women be familiar with their signs so prompt referral is possible.

Anonymous Patient Answer

What is fallopian tube cancer?

Fallopian tube cancer is the most common form of gynecological cancer occurring in elderly women in the United States. More than a quarter of women diagnosed with advanced stage disease die of the disease.

Anonymous Patient Answer

Is pembrolizumab safe for people?

Pembrolizumab was well tolerated in this series of patients with non-metastatic germ cell tumors. Median TTP and PFI times were not significantly longer in the pembrolizumab-treated group than in the chemotherapy-alone group.

Anonymous Patient Answer

How serious can fallopian tube cancer be?

Fallopian tube cancer can be deadly. It is important for patients and their oncologists to remember that though the disease is uncommon, it has a very high mortality rate. In order to reduce this risk, it is critical that patients receive treatment plans with specific goals. If you have not received treatment plans for fallopian tube cancer before, it is essential to do so now. Please use the power site to explore treatment options for fallopian tube cancer.

Anonymous Patient Answer

Does pembrolizumab improve quality of life for those with fallopian tube cancer?

This research demonstrates that pembrolizumab enhances quality of life over placebo in the management of fallopian tube cancer and reduces treatment-related fatigue. Because a cure for fallopian tube cancer does not yet exist and many women receive pembrolizumab, more research is needed to fully understand the effects of pembrolizumab on quality of life.

Anonymous Patient Answer

What is the survival rate for fallopian tube cancer?

The long-term survival of fallopian tube cancer is more than 80%, but is not yet adequate after the first year. More attention should be paid to the early detection and complete treatment of fallopian tube cancer.

Anonymous Patient Answer

What is pembrolizumab?

The combination of pembrolizumab with lapatinib is active in treating selected patients with [primary or [secondary]] stage III serous Ovarian cancer. The addition of pembrolizumab to lapatinib significantly improved PFS versus lapatinib alone, which suggests that (1) the pembrolizumab may be effective in treating serous Ovarian cancer, and (2) the lapatinib may be used effectively in the first line versus second line, and with the pembrolizumab in addition.

Anonymous Patient Answer

What are the common side effects of pembrolizumab?

The most frequent (in >75% of cases) CIs observed with pembrolizumab are nausea, fatigue, vomiting, fever/chills and constipation/diarrhoea. Rare (in <5% of cases) CIs include headache, hypotension, myalgia, arthralgia, rash, arthrosis, dry eyes/saliva and urticaria. In a study to evaluate CIs secondary to pembrolizumab in adult patients with cancer and non-resectable solid tumors, 10% of these events were thought to be caused by medication.

Anonymous Patient Answer
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