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Monoclonal Antibodies

Durvalumab for Endometrial Cancer

Phase 2
Waitlist Available
Led By Vicky Makker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights

Study Summary

This trial will test if two experimental drugs are safe and effective in treating endometrial cancer.

Eligible Conditions
  • Endometrial Cancer
  • Endometrial Carcinosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Efficacy Determined by Measuring the Overall Response Rate

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Durvalubmab + TremelimumabExperimental Treatment2 Interventions
Patients 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.
Group II: DurvalubmabExperimental Treatment1 Intervention
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
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,299 Total Patients Enrolled
19 Trials studying Endometrial Cancer
4,400 Patients Enrolled for Endometrial Cancer
Vicky Makker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
110 Total Patients Enrolled
3 Trials studying Endometrial Cancer
70 Patients Enrolled for Endometrial Cancer

Frequently Asked Questions

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

Where are patients able to participate in this trial?

"Currently, this trial is being run out of 7 sites. The locations are located in Basking Ridge, New york and Harrison along with other 5 locations. To cut down on travel time and effort, patients should select the location nearest to them."

Answered by AI

How many total patients are enrolled in this clinical trial?

"Presently, this clinical trial is not looking for new participants. The date the study was first posted was January 1st, 2017 and the most recent update to the information on the study was on January 26th, 2022. However, there are other studies you may be eligible for; 3604 trials for patients with carcinoma and 345 Durvalumab trials are actively enrolling right now."

Answered by AI

Are patients currently being recruited for this trial?

"The clinical trial in question is no longer active, based on information from clinicaltrials.gov. This particular study was looking for patients between January 1st 2017 and January 26th 2022. There are other options available though; at the moment, 3949 trials are actively recruiting patients."

Answered by AI

Have other similar trials been conducted in the past?

"Since 2007, there has been an influx of research regarding Durvalumab. In the first study completed on the topic, 37 participants were observed and it was sponsored by AstraZeneca. Based on the findings,Durvalumab received its Phase 2 drug approval in 2007. Now, 345 studies are active and taking place across 1325 cities and 58 countries."

Answered by AI

How often has Durvalumab been studied in a clinical trial setting?

"The immunotherapy drug, durvalumab, was first studied in 2007. There are now 123 completed studies and 345 active clinical trials worldwide; with a large concentration of these studies taking place in Basking Ridge, New jersey."

Answered by AI

Has Durvalumab received FDA approval in the United States?

"At Power, we gave Durvalumab a score of 2 on our safety scale. This is because while there is some evidence to support its safety, none exists for efficacy as it only just entered Phase 2 clinical trials."

Answered by AI

What are the main indications for Durvalumab?

"Most commonly, patients with unresectable stage iii non-small cell lung cancer are treated with the immunotherapy medication Durvalumab. This drug is also indicated for other conditions such as metastatic ureter urothelial carcinoma and advance directives."

Answered by AI
~10 spots leftby Apr 2025