IMGN853 for Endometrial Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
Smilow Cancer Hospital at Yale New Haven, New Haven, CT
Endometrial Neoplasms+1 More
IMGN853 - Drug
Eligibility
18+
Female
Eligible conditions
Endometrial Neoplasms

Study Summary

This study is evaluating whether a drug may help treat endometrial cancer.

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Eligible Conditions

  • Endometrial Neoplasms
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether IMGN853 will improve 1 primary outcome and 4 secondary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of 5 Years.

5 Years
Durable disease control rate (DDCR)
Duration of overall survival (OS)
Duration of progression free survival (PFS)
Objective response rate (ORR)
Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
IMGN853

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. IMGN853 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
Drug
IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

Smilow Cancer Hospital at Yale New Haven - New Haven, CT

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:
Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, or Carcinosarcoma with high grade serous or Grade 2/3 endometrioid components
Have measurable disease
Radiologically confirmed (ie, CT scan and/or MRI) persistent or recurrent endometrial cancer
FRα-positive tumor expression as defined in the protocol
Have at least one "target lesion" to be used to assess response as defined by RECIST v1.1
Patients must have received prior treatment with ≤ 3 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy
Patients must have adequate hematologic, liver and kidney function as defined in the protocol

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 endometrial neoplasms be cured?

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Many of the [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer)s can be cured in cases where the tumors are less aggressive and there are no other cancer cells in the body. The more aggressive forms of endometrial tumors can not be cured in any cases, but good treatment can reduce symptoms to a great degree in many cases. It is important to remember that endometrial neoplasm cannot be cured, but good treatments may be able to reduce their size, severity, and recurrence.

Unverified Answer

What are common treatments for endometrial neoplasms?

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Treatment of endometrial adenocarcinoma and endometrial sarcoma vary dependent on the type, grade, and the spread of the tumor. In endometrial adenocarcinoma, surgery can be useful if it has a curative intent. Radiation may improve outcomes in patients who have locally advanced or metastatic disease. Endometrial sarcoma often responds well to chemotherapy, surgery, and radiation therapy. In advanced endometrial cancer surgery and chemotherapy alone may result in long-term survival. Adjuvant therapy with chemotherapy, hormonal therapy, or radiotherapy is recommended for high-grade serous endometrial adenocarcinoma.

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

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About 1.8 million people are diagnosed with endometrial neoplasms per year in the United States. This makes up 0.5% of women 30 years and older. Most people who develop endometrial neoplasms are diagnosed every 5 to 10 years. The majority of endometrial cancer occurs in postmenopausal women.

Unverified Answer

What is endometrial neoplasms?

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Endometrial neoplasms are common, benign tumor and carcinoma accounted for 71.6% and 12.9% of cases in this study, respectively. The percentage of low grade endometrial neoplasms increased in the postmenopausal women of both age groups.

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What are the signs of endometrial neoplasms?

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There is an association between endometrial polyps and endometrial cancer. These symptoms may prompt a medical practitioner to consider an endometrial biopsy in women with polypoid endometrium.

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What causes endometrial neoplasms?

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Women with a personal history of endometrial cancer are more likely to have adenocarcinoma but not SCC. Women with adenocarcinoma have a shorter duration of symptoms and atypical symptoms such as gastrointestinal hemorrhage and abnormal vaginal bleeding. Women with no personal history of endometrial cancer are unlikely to have adenocarcinoma. Endometrioid adenocarcinoma is associated with hyper-estrogenism due to the secretory properties of adenocarcinomas while serous adenocarcinoma may be associated with hormonal replacement.

Unverified Answer

What is imgn853?

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Results from a recent paper show that imgn853 is able to potentiate cisplatin-induced apoptotic cell death in the endometrial cancer cell line EC1A; it also induces an increase in DNA accumulation in cervical cancer cells.

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Have there been any new discoveries for treating endometrial neoplasms?

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Given the increasing number of treatment options of endometrial neoplasms, we anticipate the arrival of new discoveries, and we will have to continue to update our recommendations.

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What are the latest developments in imgn853 for therapeutic use?

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Imgn853, originally developed as an alternative therapy for treatment of prostate cancer, displayed clear effects in endometrial cancer, an action mediated through the down-regulation of the cell proliferation-related gene P53. In addition, our results suggest that the drug exerts its cytotoxic effects in part through modulation of the cell cycle regulators, cyclins and c-myc, thus indicating a crucial position also for P53 in regulating cell cycle events mediated by the endometrial neoplasm and in the development of new imgn853-based strategies.

Unverified Answer

Has imgn853 proven to be more effective than a placebo?

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There is statistical significant difference in favour of Imgn853 compared to a placebo which suggests Imgn853 is more effective than a placebo when all patients are pooled. However, further studies should prove superiority of Imgn853 compared to a placebo on individual patient basis before it can be recommended in the treatment of uterine leiomyoma.

Unverified Answer

What is the survival rate for endometrial neoplasms?

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Endometrial neoplasia is a rare disease, but is often found in women who have a history of endometrial hyperplasia or carcinoma. Survival rates seem to be comparable in a recent study for endometrial adenocarcinoma and adenocarcinoma of the endometrium, although complete surgical staging was not performed. When metastasic adenocarcinoma occurs, the outcome seems to be poor as well. Follow-up must be kept up by gynecologists to monitor recurrence as well as detecting any sign of metastatic disease.

Unverified Answer
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