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Cancer Vaccine

Arm 1 for Endometrial Cancer

Phase 1 & 2

Waitlist Available

Led By Hoyoung M Maeng, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Histologically confirmed endometrial cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

"This trial is testing two study drugs in combination with two FDA-approved cancer treatment drugs to treat endometrial cancer in adults over 18 with a specific protein (HER2) in their cancer cells.

Who is the study for?

Adults aged 18+ with HER2-positive endometrial cancer that has returned or worsened after treatment. Participants must undergo apheresis to create the AdHER2DC vaccine from their own blood and may need a special catheter for this process.Check my eligibility

What is being tested?

The trial is testing a combination of two FDA-approved drugs (one pill daily, one IV) and an experimental HER2-targeting vaccine made from participants' blood, with some also receiving N-803 to boost immune cells. Treatments last up to a year with follow-up visits for two more years.See study design

What are the potential side effects?

Potential side effects include reactions at injection sites, possible organ inflammation due to immune response, fatigue, digestive issues related to oral medication, and general risks associated with intravenous drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer diagnosis was confirmed through tissue examination.

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My kidney function, measured by creatinine clearance, is within the required range.

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My cancer has spread beyond its original location.

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My endometrial cancer has worsened after at least one treatment.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Phase I: Estimate recommended RP2D of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer

Phase II: Preliminarily assess the efficacy of a combination of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer

Secondary outcome measures

Determine the safety of the combination of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment5 Interventions

AdHER2DC vaccine + N-803 + pembrolizumab + RP2D of lenvatinib

Group II: Arm 1Experimental Treatment4 Interventions

AdHER2DC vaccine + pembrolizumab + de-escalating doses of lenvatinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

N-803

2021

Completed Phase 2

~30

Lenvatinib

2005

Completed Phase 4

~2690

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,311 Total Patients Enrolled

74 Trials studying Endometrial Cancer

73,314 Patients Enrolled for Endometrial Cancer

Hoyoung M Maeng, M.D.Principal InvestigatorNational Cancer Institute (NCI)

5 Previous Clinical Trials

121 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for patient participation in this clinical trial?

"As per clinicaltrials.gov, this particular study is no longer enrolling participants. Its initial posting was on February 15th, 2024, with the last update made on February 9th, 2024. However, out of the numerous ongoing trials available for enrollment currently, there are precisely 2741 studies actively seeking candidates."

Answered by AI