CLINICAL TRIAL

Pembrolizumab for Sarcoma

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether a combination of drugs may help treat soft tissue sarcomas.

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About the trial for Sarcoma

Eligible Conditions
Sarcoma · Advanced Sarcoma

Treatment Groups

This trial involves 5 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 5 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
Pembrolizumab
DRUG
+
Lenvatinib
DRUG
Experimental Group 2
Pembrolizumab
DRUG
+
Lenvatinib
DRUG
Experimental Group 3
Pembrolizumab
DRUG
+
Lenvatinib
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The study compared the outcomes of two groups of patients with sarcoma: Cohort D, which included patients with soft tissue sarcomas other than synovial sarcoma and malignant peripheral nerve sheath tumor, and Cohort E, which included patients with bone sarcomas other than osteosarcoma and chondrosarcoma. show original
Compliance with treatment is important to ensure successful treatment. show original
If you need tissue for a study, archival tissue is available show original
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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: 27 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 27 weeks.
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 1 secondary outcome in patients with Sarcoma. Measurement will happen over the course of at 27 weeks.

best overall response rate
AT 27 WEEKS
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
progression-free survival (PFS)
27 WEEKS
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

Patient Q & A Section

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

Can sarcoma be cured?

Sarcoma is not a disease that can be cured. However, with good early treatment, and in most cases with chemotherapy and radiation, remission can be achieved, and over a long period life can be extended with no apparent side effects, although with the risk of relapse. Further long-term follow-up and larger studies are needed.

Anonymous Patient Answer

What is sarcoma?

Sarcomas are a group of tumors that form from epithelial cells. They can be primary or metastatic in origin. Sarcomas can form from cells in a variety of body tissues, including the connective tissue, muscle, or blood glands. The most common form of this cancer is benign. In contrast, malignant sarcomas form in body tissue in which the cells multiply abnormally. They develop in almost any type of tissue and typically occur in older adults and adolescents. The five-year survival rate for primary cancers is between 80% and 90%, and for metastatic sarcomas is 40%. In the United States, sarcomas account for about 3,100 deaths in 2010.

Anonymous Patient Answer

What causes sarcoma?

Sarcomas are rare in children and adolescents and are often associated with an underlying disease. The majority of pediatric sarcomas are malignancies derived from mesenchymal cells and may follow a multifocal pattern of spread, or be metastatic at the time of diagnosis. Pediatric sarcoma is rarely seen without an associated disease. Surgical resection may improve outcomes of pediatric sarcomas.

Anonymous Patient Answer

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

About 7,600 people will be diagnosed with sarcoma in the US in 2020, an increase of 24.5% from 2010. The average age of diagnosis will be 68.9 years, and the death rate will be 15.4 deaths per 100,000 people. The incidence of osteosarcoma presents the highest increase, from 9.6 per 100,000 in 2010 to 18.7 per 100,000 a year in 2020. The peak year for the incidence of Ewing sarcoma will be 2020, with 3.7 cases per 100,000 population.

Anonymous Patient Answer

What are the signs of sarcoma?

The five most characteristic signs of sarcoma are: 1) Bilateral symmetrically spread pain(s) such as diffuse, bony pain; 2) Coughing up bloody blood; 3) Abdominal pain, which may occur when the sarcoma has spread from the gut; 4) Nausea; and 5) Lymph nodes of any size. Other signs and symptoms are common and may indicate sarcoma. Patients with sarcoma often complain of low-grade fevers, easy bruising and bleeding, and the onset of new, abnormal growths on the bone. However, symptoms may also indicate other possible conditions.

Anonymous Patient Answer

What are common treatments for sarcoma?

Treatment is usually multidisciplinary and includes surgery, chemoradiation, and sometimes chemotherapy and/or target therapy. Prognosis is poor for [soft tissue sarcoma](https://www.withpower.com/clinical-trials/soft-tissue-sarcoma)s, with only moderate activity observed in bone and lung sarcomas.

Anonymous Patient Answer

Does pembrolizumab improve quality of life for those with sarcoma?

Amongst patients with sarcoma, those receiving pembrolizumab demonstrated meaningful improvement in FOLFIQoL subscales. The pembrolizumab group also demonstrated a lower risk of serious adverse events compared to patients on placebo, although not statistically significant. Further work should be done to examine the impact of chemotherapy in sarcoma and evaluate patient reported outcomes, because improvement is only expected at higher doses of pembrolizumab and is also not clinically meaningful.

Anonymous Patient Answer

What is the latest research for sarcoma?

It is a dynamic area that is rapidly changing, it should only be done as an area of scientific study when there are significant benefits to the patient that would outweigh potential risks. However, the research being provided by the scientific community to treat sarcoma patients is becoming more and more effective and is becoming the standard of care for most sarcoma patients, especially in the United States - most sarcoma patients are being treated as outpatients or as inpatients with chemotherapy and other chemotherapy agents.

Anonymous Patient Answer

Who should consider clinical trials for sarcoma?

The potential for clinical benefit to sarcoma is substantial and our results show that clinical trials are feasible and potentially beneficial. Identifying the subset of patients who are likely to benefit from trials may help to further assess the applicability and value of clinical trials of sarcoma. Identifying these patients is challenging at this phase of our clinical experience.

Anonymous Patient Answer

What is the primary cause of sarcoma?

Sarcomas may arise in all races and all socioeconomic groups. The most frequent sites for sarcoma are the chest and retroperitoneum. Given the overall low risk of developing sarcoma, as long as sarcomas are diagnosed early, most sarcomas may be treated by excision in an inpatient setting and the patient will resume their normal daily lifestyle. However, if untreated, sarcomas have a low survival rate; therefore, the ultimate goal is to diagnose sarcomas early when they are small and hopefully with a curative intent. The key to cure sarcomas and make them more manageable lies in early detection and excisional biopsy.

Anonymous Patient Answer

What is the average age someone gets sarcoma?

Sarcoma of the heart and aortic aneurysms are the most common. Most individuals have either a localized or a metastatic disease. The risk of sarcoma is increased during adulthood; the peak in lifetime risk of sarcoma occurring after age 70 years. No statistical differences were seen between genders, ethnicity or socioeconomic conditions. More work is needed to assess the impact of environmental and lifestyle factors on sarcoma risk and whether ethnicity has a role to play in sarcoma risk.

Anonymous Patient Answer
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