Durvalumab for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Commack, Commack, NY
Carcinoma+9 More
Durvalumab - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called durvalumab can be used to treat endometrial cancer.

See full description

Eligible Conditions

  • Carcinoma
  • Endometrial Carcinosarcoma
  • Recurrent Endometrial Carcinoma
  • Endometrial Cancer
  • Endometrial Carcinoma
  • Endometrial Cancer Recurrent

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome in patients with Carcinoma. Measurement will happen over the course of From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Month 100
Treatment Efficacy determined by measuring the Overall Response Rate

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Durvalubmab + Tremelimumab
1 of 2
Durvalubmab
1 of 2
Experimental Treatment

This trial requires 80 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.

Durvalubmab + TremelimumabPatients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalubmab
Drug
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
Not yet FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months for reporting.

Closest Location

Memorial Sloan Kettering Commack - Commack, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 9 conditions 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:
Subjects must have recurrent or persistent endometrial carcinoma (including: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma) or endometrial carcinosarcoma show original
In order to be eligible for this study, patients must have one target lesion that will be used to assess response show original
A person's ANC is ≥ 1.5 x 10^9/L (> 1500 per mm^3) if their absolute neutrophil count is at least 1.5 x 10^9/L. show original
A platelet level of 100,000 or more is considered high. show original
Patients with endometrial carcinoma or carcinosarcoma must have received one previous platinum-based chemotherapy regimen show original
A patient has measurable disease if they have at least one lesion that is measurable in at least one dimension show original
Adults aged 18 years or older who have a life expectancy of at least 12 weeks are eligible to donate plasma. show original
The patient has a good performance status, which is characterized as 0 or 1 by the Eastern Cooperative Oncology Group. show original
Before starting their treatment, patients must resolve any adverse effects from surgery, radiation therapy, or chemotherapy to a level of ≤1 show original
Patients are allowed to receive, but are not required to receive, three additional cytotoxic regimens for management of recurrent or persistent disease show original

Patient Q&A Section

Can endometrial neoplasms be cured?

"Stage I endometrial cancer is cured if the patient does not develop recurrent disease after surgery. Stage 2 endometrial cancer can be cured in the long run by surgery. However, endometrial cancer stage 3 or more and stage 4 can not be cured. There is no cure for advanced endometrial cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of endometrial neoplasms?

"Endometrial endometrioid adenocarcinoma shows answer: A combination of a history of endometrial cancer and vaginal bleeding in the later period after menopause, particularly vaginal bleeding per vagin examination or change in menstruation intervals, are good indicators for endometrial endometrioid adenocarcinoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for endometrial neoplasms?

"The treatment of endometrial neoplasms depends on the subtype of malignancy (e.g., adenocarcinoma, endocervical intraepithelial neoplasia, or adenocarcinoma with endosseous invasion), the stage of the disease (i.e., stage I endometrial adenocarcinoma requires a lesser amount of therapy than the same disease at a higher stage), and the patients own preferences (e.g., the women can opt for lumpectomy or total hysterectomy instead of chemotherapy treatment)." - Anonymous Online Contributor

Unverified Answer

What causes endometrial neoplasms?

"endometrium was more likely in patients with diabetes. Patients with estrogen-producing tumors were more likely to develop a non-mucinous endometrial neoplasm. Estrogen-producing tumors were more likely in nulliparous women with endometrial hyperplasia. The high risk of developing non-mucinous endometrial neoplasms in patients with diabetes may reflect the increased hormonal burden present after pregnancy. These data support the concept that endometrial hormones have a role in endometrial transformation." - Anonymous Online Contributor

Unverified Answer

What is endometrial neoplasms?

"Endometrial neoplasms form when cells of the endometrial lining proliferate at an accelerated rate. Most commonly, it is caused by endometrial hyperplasia and adenocarcinoma. Symptoms include abnormal menorrhagia or menstrual loss." - Anonymous Online Contributor

Unverified Answer

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

"The number of patients with EMN seems to be rising in the USA, although the underlying trends are not clear. Because of the significant increase, it seems reasonable to monitor the epidemiology of EMN." - Anonymous Online Contributor

Unverified Answer

Is durvalumab typically used in combination with any other treatments?

"The authors' current combination therapy has resulted in a durable response in a select group of patients with various ECA and endometrioid ENC. This treatment regimen is a safe combination and adds no inconvenience to the well-tolerated therapy of most patients. Patients have demonstrated the benefit of this therapy as a means of managing patients with ECA and endometrioid endometrial cancer as long as they are able to maintain adherence during the administration. However, in most instances, the maintenance of regular therapy is necessary." - Anonymous Online Contributor

Unverified Answer

Is durvalumab safe for people?

"Results from a recent paper from this initial phase I study support the continuation of a 12-month duration study of durvalumab in metastatic endometrial cancers patients. The safety and tolerability of durvalumab were acceptable." - Anonymous Online Contributor

Unverified Answer

Has durvalumab proven to be more effective than a placebo?

"Results from a recent clinical trial suggests that durvalumab significantly improves survival time for patients who received a surgical procedure for pelvic adenocarcinoma compared to those who received a placebo while receiving multimodal therapy in addition to surgery. Further studies may be required to determine how to combine chemotherapy and vaccines in a more effective treatment regimen for patients treated surgically." - Anonymous Online Contributor

Unverified Answer

How does durvalumab work?

"The mechanism of action for durvalumab remains unknown, but it appears to function primarily through blocking IFNγ. Whether IFNγ is the primary mediator of the therapeutic effects of durvalumab remains to be seen." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of endometrial neoplasms?

"Results from a recent paper of this study support previous study data suggesting that the sole causative factor in endometrial neoplasms is hyperplasia, followed by dysplasia. The main risk factor for developing endometrial neoplasms is the patient's age at first childbearing." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for endometrial neoplasms?

"Survival in women with endometrioid adenocarcinoma and endometrial carcinosarcoma is significantly better than for patients with other histological types of endometrial carcinoma. Women with endometrioid adenocarcinoma should be evaluated for surgical options with regard to adjuvant treatment and possible resection rather than primary chemotherapy alone." - 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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