Durvalumab for Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Princess Margaret Cancer Centre, Toronto, Canada
Leiomyosarcoma+2 More
Durvalumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called olaparib can improve the survival of people with advanced colorectal cancer.

See full description

Eligible Conditions

  • Leiomyosarcoma
  • Adenocarcinomas of the Pancreas
  • Mismatch Repair Proficient Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leiomyosarcoma

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 6 secondary outcomes in patients with Leiomyosarcoma. Measurement will happen over the course of 3 years.

3 years
Antitumor activity based on iRECIST
Changes in genomic and immune biomarkers that will be measured in the baseline biopsy and the first on-treatment biopsy by applying a log-transformation and the t-test.
Clinical benefit rate (CBR)
Incidence of treatment-emergent adverse events (AEs)
Overall response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Progress

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

Other trials for Leiomyosarcoma

Trial Design

2 Treatment Groups

Cohort B
1 of 2
Cohort A
1 of 2
Experimental Treatment

This trial requires 90 total participants across 2 different treatment groups

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

Cohort BCediranib (given orally at a dose of 20 mg daily, 5 days on 2 days off) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)
Cohort AOlaparib (given orally at a dose of 300 mg twice a day) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Cediranib
Not yet FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Princess Margaret Cancer Centre - Toronto, Canada

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Signed informed consent
Age ≥18
ECOG 0-1
Have histologically/cytologically-documented, locally-advanced, or metastatic mismatch repair proficient colorectal cancer (MMRp-CRC), pancreatic adenocarcinoma (PA), or leiomyosarcoma (LMS) that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the subject and treating physician
Allowable: prior immune-oncology therapy, no maximal limit to the number of prior lines of systemic therapy for advanced or metastatic disease. All prior anti-neoplastic systemic therapy, including immune-oncology, must have a 4 week wash out period. There is no limit to the number of prior anti-neoplastic systemic treatments used before trial enrolment
Must have at least 1 tumor site that is amendable to tumor biopsy
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided will not be eligible for this study. Subjects who have archival tissue available, not older than 6 months and with no intervening therapies from the day of the biopsy and the initiation of the study, will also be requested to also submit this sample, but are still required to undergo a pre-treatment biopsy.
Consent to provide archival tumor tissue for correlative biomarker studies
Must have at least 1 tumor site that is RECISTv1.1 measurable by CT or MRI scan. A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable and there is objective evidence of progression following radiotherapy. The biopsy lesion cannot be the same as the target lesion
Life expectancy ≥ 16 weeks from proposed first dose date

Patient Q&A Section

What causes leiomyosarcoma?

"In the majority of cases, leiomyosarcoma is a sporadic benign tumor of the leiomyomata. It is usually discovered on histopathology. The occurrence of it is higher among women who have had a molar pregnancy. Smoking may be a protective factor." - Anonymous Online Contributor

Unverified Answer

What are the signs of leiomyosarcoma?

"It is common for women with uterine leiomyofibroids to have a palpable mass. However, the most common signs of leiomyosarcoma are fever, weight loss and malaise. Because leiomyosarcoma does not often produce symptoms and is, by its nature, a silent disease, it is important for physicians and patients to suspect this diagnosis as an underlying cause of fever, weight loss and malaise." - Anonymous Online Contributor

Unverified Answer

Can leiomyosarcoma be cured?

"Treatment of a limb sarcoma with surgery and radiation is a realistic goal, especially in a very-low-grade, early-stage primary lesion. However, most such patients continue to have local recurrence. At this time, no adjuvant therapy has been shown to improve local control or metastasis-free survival. Therefore, the focus is on improving local control of the disease by use of local radiotherapy, chemotherapy, and a biologic or immunologic intervention. This approach may produce long-term local control, progression-free survival, and enhanced metastasis-free survival rates in the future." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leiomyosarcoma?

"This retrospective study shows the treatment of leiomyosarcoma in our institution which includes surgery, chemotherapy, radiation, and targeted therapy. Tumor type was no predictor of the treatment or survival. Further studies with larger number of cases will be needed for additional analysis of treatment response." - Anonymous Online Contributor

Unverified Answer

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

"The leiomyosarcoma rate in the United States was 3.8 per million persons aged 15 years and older during 2004-2006. This rate was nearly doubled among women over age 60 compared with those in their 30s or early 40s. While leiomyosarcoma may occur at any age and at any site in the body, incidence and prevalence peaks between age 50 and 68 years." - Anonymous Online Contributor

Unverified Answer

What is leiomyosarcoma?

"These cases demonstrate a wide spectrum of clinical and biological features of leiomyosarcoma. We suggest that a pathophysiology-oriented approach is needed to treat this disease. It is important to note that with effective and early therapy, this disease can often be cured." - Anonymous Online Contributor

Unverified Answer

How serious can leiomyosarcoma be?

"As in the pediatric population, age at diagnosis > or =40 is the most important predictor of improved prognosis in the adult population. The age at diagnoses 45-74 years is also an important predictor for improved survival in adult cases of leiomyosarcoma. Although leiomyosarcoma is regarded as a dismal disease, it has favorable prognosis compared with Ewing sarcoma and soft tissue sarcoma." - Anonymous Online Contributor

Unverified Answer

Does durvalumab improve quality of life for those with leiomyosarcoma?

"Durvalumab may improve the quality of life of patients with leiomyosarcoma. As of September 2019, the drug is not approved by either FDA or EMA for treatment of patients with leiomyosarcoma. It would be considered for treatment in a clinical trial.\n" - Anonymous Online Contributor

Unverified Answer

What is durvalumab?

"Durvalumab is used to treat patients with metastatic leiomyosarcoma (mesenchymal tumors of smooth muscle) who do not respond to previous standard therapy. It has been well tolerated without a significant increase in toxicity. However, patients on the monotherapies have increased risk of progressive disease and death over patients receiving combination therapy. Furthermore, it has been shown to prolong survival in several studies using this as single/combination therapy. In fact, patients treated with durvalumab as a combination therapy have shown increased overall survival. The recommended dose of 200 μg per square meter every 2 weeks is efficacious." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in durvalumab for therapeutic use?

"The therapeutic role of durvalumab in refractory/relapsed solid tumors has recently been demonstrated in randomized controlled trials and observational cohorts. This agent has now begun its development at a clinical-trial center in Paris. As data are being collected from this phase IIb trial, the role of durvalumab in metastatic solid tumors is being investigated." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leiomyosarcoma?

"The incidence of uterine leiomyosarcoma is very low. Its primary cause among white women younger than 35 years is uterine fibroids. In all age groups, the primary cause among black women is ovarian cancer. Atypical leiomyosarcoma seems to be associated with uterine leiomyoma or fibroids in black women but not in white women. The most common presenting symptom is vaginal bleeding, but it can happen at any age." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of durvalumab?

"This is the first report on side effects from clinical trial data of Durvalumab in metastatic leiomyosarcoma. As a monoclonal antibody, Durvalumab has one of the lowest incidence of common adverse event." - 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.
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