Pembrolizumab for Endometrial Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Endometrial Neoplasms+1 More
Pembrolizumab - Drug
Eligibility
18+
Female
Eligible conditions
Endometrial Neoplasms

Study Summary

A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)

See full description

Eligible Conditions

  • Endometrial Neoplasms
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of 6 months.

2 Years
Immune-related progression of disease
Overall Survival
2 years
Duration of response
Immune-related progression-free survival
6 months
Objective Response Rate
Progression Free Survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
IMGN853 + Pembrolizumab

This trial requires 35 total participants across 2 different 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.

IMGN853 + PembrolizumabPembrolizumab is administered intravenously once every 3 weeks IMGN853 is administered intravenously once every 3 weeks
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
P. K.
Panagiotis Konstantinopoulos,, MD PhD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Endometrial Neoplasms or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If the archival tumor does not meet the FRα criteria, then a fresh biopsy tumor sample may be submitted and used to meet this criterion show original
You don't need to wait to start treatment if you've been treated with hormones before, and you don't have to count hormonal therapy as a line of treatment show original
The tumor is considered microsatellite stable (MSS) if it shows intact immunohistochemical (IHC) nuclear expression of the mismatch repair genes MSH2, MSH6, MLH1 and PMS2, or is microsatellite stable by polymerase chain reaction (PCR), next generation sequencing, or another CLIA-approved method. show original
Patients must have a disease that can be measured using RECIST 1.1 guidelines show original
Patients are required to have one, but no more than three lines of chemotherapy for endometrial carcinoma in order to be eligible for prior therapy. show original
Up to 19 patients in the cohort are allowed prior IO therapy that targets the PD-1/PD-L1 pathway. show original
Patients must NOT have received prior therapy with any other agents that bind to folate receptors. show original
Children aged 18 or older years are allowed to participate in the study show original
A patient with an ECOG performance status of 0 or 1 is considered to have a good prognosis. show original

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 endometrial neoplasms?

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The following is from the American gynaecological pathology service (USA) (see reference list, 9[17]). The exact composition of the lesions is unknown. They usually have no or only vague signs of malignancy on light microscopy. An endometrial biopsy has to be performed, because the underlying histologies may differ significantly from benign lesions.

Unverified Answer

How many people get endometrial neoplasms a year in the United States?

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The American Cancer Society estimates 3,817 new diagnosed cases of the main invasive [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer) subtypes will be made in 2020. This cancer will be the most common cause of cancer-related death in American women (1.7% of deaths will be caused an endometrial or endometrioid type of endometrial cancer) with an estimated 33,100 deaths.

Unverified Answer

What are common treatments for endometrial neoplasms?

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Treatment options for endometrial neoplasms are dependent on the specific type of malignancy, but most treatments are aimed at eliminating either the abnormal blood supply, or the presence of the tumour. The goals of management for all cases are to relieve symptoms, eliminate recurrent bleeding, maintain fertility and control symptoms. A multidisciplinary tumour board will consider optimal management based on the tumour type, stage, location, grade, underlying cause, recurrence, metastatic spread and symptom control needs.

Unverified Answer

Can endometrial neoplasms be cured?

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Although it has been demonstrated that endometrial neoplasms can be cured in select cases, this process is not guaranteed in all cases. However, if complete removal is possible (either through cure or total resection), many patients do well.

Unverified Answer

What causes endometrial neoplasms?

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The causes of [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer) are unknown, although some known aetiologic factors are discussed, some of which have been suggested in other cancers, such as tobacco smoking and endometrial atrophy.

Unverified Answer

What are the signs of endometrial neoplasms?

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Endometrial cancer has some of the same signs and symptoms as endometrial polyps. These include bleeding with menses or between periods, painless swollen lump, itching or a burning sensation with urination, and a change in vaginal bleeding.

Unverified Answer

What are the chances of developing endometrial neoplasms?

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The odds of developing endometrial neoplasms in a patient with a history of hysterectomy or adnexal cancer, pelvic surgery, and menarche less than 15 and more than 21 were greater than 10 and 5 times, respectively, those in the general population in this cohort. In a recent study, findings have ramifications for cancer control, as endometrial cancer screening should be offered.

Unverified Answer

How quickly does endometrial neoplasms spread?

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The data suggest that advanced endometrial carcinoma is usually locally invasive but seldom multifocal and that infiltrative and lymphatic spread may have a limited impact on disease-specific mortality, because early spread does not confer an increased risk of late-stage disease. The data also indicate that the presence of uterine lymphadenopathy is an independently negative prognostic factor in early stage disease as well as in the presence of lymphadenopathy.

Unverified Answer

Who should consider clinical trials for endometrial neoplasms?

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The overall incidence of endometrial cancer is rising, but there is not an increased proportion of menopausal patients with this disease. The most common symptom is abnormal vaginal bleeding, which is the most frequent reason for endometrial screening during the period of this study. Clinical trials evaluating the adjuvant effects of therapy with estrogen receptor antagonists or nonsteroidal anti-inflammatory drugs are worthwhile.

Unverified Answer

How serious can endometrial neoplasms be?

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Advanced stage endometrial cancer represents an increased risk for recurrence and is associated with an increased risk for distant metastases and mortality. Endometrial cancer patients should be informed that they can expect adjuvant therapy with postoperative chemotherapy or radiotherapy and that recurrence and death can occur.

Unverified Answer

Have there been other clinical trials involving pembrolizumab?

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The current phase 3 trial on pembrolizumab in mHCC patients has been extended. More importantly, a pembrolizumab phase 2 trial with recurrent HCC is underway, and there have been two successful phase 2 trials regarding pembrolizumab as a companion therapy in combination with sorafenib in HCC patients.

Unverified Answer

Has pembrolizumab proven to be more effective than a placebo?

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Findings from a recent study suggest that the addition of pembrolizumab to chemotherapy does not result in better disease-free and overall DFS compared to standard chemotherapy in patients with advanced EOC. This confirms that the use of pembrolizumab in metastatic EOC should not be considered an option of first-line chemotherapy.

Unverified Answer
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