Pembrolizumab for Endometrial Neoplasms

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

Study Summary

This study is evaluating whether pembrolizumab is effective in treating endometrial cancer.

See full description

Eligible Conditions

  • Endometrial Neoplasms
  • Recurrent Endometrial Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 2 secondary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of 24 months.

24 months
Duration of progression-free survival (PFS)
Frequency and severity of adverse events as assessed by CTCAE v4
Frequency of objective tumor response as assessed by RECIST 1.1
Overall survival (OS)

Trial Safety

Safety Estimate

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

Compared to trials

Side Effects for

Pembrolizumab + Etoposide
Neutropenia
54%
Anaemia
45%
Nausea
38%
Alopecia
34%
Decreased appetite
31%
Constipation
29%
Fatigue
27%
Thrombocytopenia
26%
Leukopenia
22%
Diarrhoea
20%
Cough
20%
Asthenia
17%
Dyspnoea
17%
Vomiting
16%
Pyrexia
14%
Dizziness
14%
Rash
13%
Headache
13%
Pruritus
11%
Insomnia
11%
Back pain
11%
Hypothyroidism
10%
Weight decreased
10%
Aspartate aminotransferase increased
9%
Hyponatraemia
9%
Arthralgia
9%
Alanine aminotransferase increased
8%
Oedema peripheral
8%
Pneumonia
8%
Upper respiratory tract infection
7%
Blood creatinine increased
7%
Abdominal pain
7%
Febrile neutropenia
7%
Hypokalaemia
7%
Dry skin
6%
Dysgeusia
6%
Stomatitis
6%
Hyperthyroidism
6%
Abdominal pain upper
6%
Dyspepsia
5%
Blood alkaline phosphatase increased
5%
Erythema
5%
Chest pain
5%
Hypertension
5%
Dysphagia
5%
Musculoskeletal pain
5%
Nasopharyngitis
5%
Musculoskeletal chest pain
5%
Pain in extremity
5%
Hypotension
4%
Pneumonitis
2%
Acute kidney injury
2%
Pulmonary embolism
2%
Atrial fibrillation
2%
Death
2%
Pneumothorax
1%
Hemiparesis
1%
Diabetes mellitus
1%
Superior vena cava syndrome
1%
Transient ischaemic attack
1%
Inappropriate antidiuretic hormone secretion
1%
Neutropenic sepsis
1%
Gastritis
1%
Aortic aneurysm
1%
Sepsis
1%
Pleural infection
1%
Infusion related reaction
1%
Clostridium difficile colitis
1%
Urinary tract infection
1%
Decubitus ulcer
0%
Cardiac arrest
0%
Spinal fracture
0%
Laryngeal haemorrhage
0%
Bacteraemia
0%
Fall
0%
Appendicitis
0%
Acute coronary syndrome
0%
Pericardial effusion
0%
Cholecystitis
0%
Haemoptysis
0%
Urosepsis
0%
Dehydration
0%
Autoimmune nephritis
0%
Oropharyngeal pain
0%
Embolism
0%
Escherichia sepsis
0%
Confusional state
0%
Serratia sepsis
0%
Hypertensive crisis
0%
Peripheral motor neuropathy
0%
Type 1 diabetes mellitus
0%
Aphasia
0%
Paraneoplastic syndrome
0%
Infective exacerbation of chronic obstructive airways disease
0%
Spinal osteoarthritis
0%
Tremor
0%
Skin laceration
0%
Cerebrovascular accident
0%
Bronchospasm
0%
Deep vein thrombosis
0%
Femur fracture
0%
Gastrointestinal viral infection
0%
Loss of consciousness
0%
Hypoxia
0%
Benign prostatic hyperplasia
0%
Cholecystitis infective
0%
Empyema
0%
Epistaxis
0%
Hepatotoxicity
0%
Prostatitis
0%
Diverticulitis
0%
Diverticulum
0%
Hypopituitarism
0%
Cardiopulmonary failure
0%
Haematemesis
0%
Food poisoning
0%
Myocarditis
0%
Vitreous haemorrhage
0%
Myocardial infarction
0%
Secondary adrenocortical insufficiency
0%
Pneumonia haemophilus
0%
Chronic obstructive pulmonary disease
0%
Cognitive disorder
0%
Subacute cutaneous lupus erythematosus
0%
Haematuria
0%
Pseudomonas infection
0%
Peripheral embolism
0%
Lower respiratory tract infection
0%
Joint injury
0%
Cancer pain
0%
Proctitis
0%
Limbic encephalitis
0%
Gouty arthritis
0%
Colitis
0%
Keratitis
0%
Neurogenic bladder
0%
Toxic encephalopathy
0%
Gastroenteritis
0%
Cardiac failure
0%
Tooth infection
0%
Pain
0%
Pneumonia aspiration
0%
Vertigo
0%
Bronchitis
0%
Pleural effusion
0%
Peripheral artery occlusion
0%
Atypical pneumonia
0%
Myositis
0%
Paracancerous pneumonia
0%
Autoimmune uveitis
0%
Respiratory failure
0%
Herpes zoster
0%
Oesophagitis
0%
Vena cava thrombosis
0%
Influenza
0%
Presyncope
0%
Hyperglycaemia
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab + Etoposide ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

2 Treatment Groups

Control
Pembrolizumab

This trial requires 25 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.

Pembrolizumab
Drug
Pembrolizumab 200 mg, Q3W, IV Infusion, Day 1 of each 3 week cycle
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: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

Yale New Haven Hospital - 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:
Testing for tumors that exhibit ultramutation (POLE/POLD1-mutation) and/or hyper-mutation (due to MMR gene defect) is done using next generation sequencing (NGS) and Comprehensive Genomic Profiling (CGP) show original
Patients with endometrial cancer may have received prior hormonal therapy to treat their cancer show original
Patients who have received prior therapy for the treatment of endometrial cancer must discontinue all therapy at least 3 weeks before the first date of study therapy show original
This eligibility criteria is for patients with histologic epithelial cell types including: Endometrioid adenocarcinoma, serous adenocarcinoma, clear cell carcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, carcinosarcoma, and adenocarcinoma not otherwise specified. show original
Any woman who could potentially become pregnant must have a negative pregnancy test within 72 hours of receiving the first dose of Pembrolizumab, and must agree to use contraception for the next 120 days after receiving the last dose of Pembrolizumab. show original
Patients may have received radiation therapy as treatment for endometrial cancer show original
Patients must have a good performance status on the ECOG scale, which ranges from 0 (fully active) to 5 (dead). show original
Patients must have histologically confirmed stage III, IV, or recurrent endometrial cancer. show original
Patients must have recovered from the side effects of recent surgery, radiotherapy, or chemotherapy show original
Patients must have measurable disease according to RECIST 1.1 criteria. 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.

Can endometrial neoplasms be cured?

Add answer

Results from a recent clinical trial provide evidence that uterine fibroids and endometrioid adenocarcinomas have a different phenotype from leiomyomas and are relatively responsive to hormonal treatment.

Unverified Answer

What is endometrial neoplasms?

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Endometrial neoplasms form in the lining of the uterus and can occur in a variety of forms. The most common form is endometrial hyperplasia and premalignant lesions (atypical hyperplasia), which can go on to develop into a cancer. Signs of endometrial cancers include abnormal vaginal bleeding for more than a month, abnormal vaginal bleeding with sudden increased weight, painful urination, unexplained weight loss, vaginal bleeding after a fall, infertility, and pain in the back or pelvis. Physicians frequently use the combination of these symptoms, together with abnormal blood tests, to exclude the possibility of an underlying disease.

Unverified Answer

What are common treatments for endometrial neoplasms?

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In the absence of symptomatic symptoms or mass, trans-abdominal or trans-vaginal ultrasound should be done periodically, because it has the highest positivity (100%) for endoscopic or laparoscopic screening and surgery.

Unverified Answer

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

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Overall [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer) is a relatively uncommon malignancy in the United States. The incidence rates of the histologic types of endometrial cancer are markedly different: endometrioid is most frequently found in women aged 50 to 60 years; hyperplastic, serous, and mixed endometrioid types occur less frequently but more frequently in those under the age of 40. The annual incidence of endometrial cancer is slightly higher at the end of the fifth decade when compared with the beginning of the fifth decade. Older women have significantly higher rates of cancer.

Unverified Answer

What are the signs of endometrial neoplasms?

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The symptoms of endometrial neoplasms are nonspecific, and diagnosis is often delayed. Screening for endometrial cancer with CA-125 and serum HE4 determination could aid early diagnosis and appropriate treatment of endometrial neoplasms.

Unverified Answer

What causes endometrial neoplasms?

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[endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer) occurs in women of all ages. question: Do older women with endometrial cancer have different survival as in younger patients? answer: In this sample of older women, cancer spread and recurrence characteristics were similar to those described in younger women. Survival was poorer, however, and was associated with higher-stage cancers and poorer PS.

Unverified Answer

How serious can endometrial neoplasms be?

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A large proportion of endometrial neoplasms (37%) recurred after initial resection with a rate of recurrence exceeding 50% in more than three of seven cases. Survival beyond 1 year after first surgery was significantly better in cases of stage I tumors and endocervical type carcinomas.

Unverified Answer

Who should consider clinical trials for endometrial neoplasms?

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A prospective assessment using the three proposed criteria led to a high prevalence of candidates, an indication of how important it is to implement the criteria in clinical practice and an opportunity to analyze the possible use of these criteria in the selection of candidates to clinical trials.

Unverified Answer

How does pembrolizumab work?

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As an anti-CD20 monoclonal antibody, pembrolizumab exerts its anti-inflammatory action in patients with SLE. This may explain the clinical benefit seen in phase III clinical trial, where pembrolizumab was in turn found to be effective at improving SLE disease activity, decreasing the need for systemic corticosteroids, reducing flare rates, and inhibiting the formation of new relapses.

Unverified Answer

What is the average age someone gets endometrial neoplasms?

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The median age at endometrial carcinoma was 58 years, and at endometrial adenocarcinoma was 65 years. Most patients were Caucasian and over half were postmenopausal. The ratio of endometrial carcinoma to endometrial adenocarcinoma is changing, in part due to the increase in the incidence rate of adenocarcinoma after treatment with radiotherapy.

Unverified Answer

What is pembrolizumab?

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The use of pembrolizumab (PD-1i) in patients with advanced or metastatic urothelial carcinoma was associated with better antitumor activity as demonstrated by superior clinical response rate, progression-free survival, and overall survival compared with chemotherapy alone or chemotherapy plus pazopanib. Patients who received the treatment of pembrolizumab had a longer survival time compared with the group of patients who received chemotherapy alone or chemo plus pazopanib. Pembrolizumab showed a good safety profile, with no evidence of hepatotoxicity, neoplastic transformation, or serious infections.

Unverified Answer

Does endometrial neoplasms run in families?

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In contrast to other hereditary cancers, endometrial neoplasms occur in families rather than singly. The most prevalent types are endometrial stromal tumor and carcinosarcoma and these are found in the same families. Findings from a recent study suggest that there is only limited evidence of an inherited polygenic susceptibility to neoplasm for this rare and devastating disease.

Unverified Answer
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