RecruitingPhase 2NCT05795244

Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)

A Phase II Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)


Sponsor

Yonsei University

Enrollment

30 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

phase 2 clinical trial to confirm the pathological complete response rate of PD-1 blocker use in patients with Mismatch Repair Deficiency(MMRd) endometrial cancer that can be completely resected surgically.


Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving an immunotherapy drug (nivolumab) before surgery — called neoadjuvant treatment — can improve outcomes in women with a specific type of uterine cancer that has a genetic marker called mismatch repair deficiency (dMMR), making it potentially more responsive to immunotherapy. **You may be eligible if...** - You are female and 20 years or older - You have been diagnosed with endometrial cancer or carcinosarcoma confirmed by tissue analysis - Your tumor has the dMMR (mismatch repair deficient) genetic marker - Your cancer is at stage I–IIIC2 and is resectable (can be removed by surgery) - You have signed informed consent **You may NOT be eligible if...** - Your cancer does not have the dMMR marker - Your cancer is at stage IVA or IVB - You have had prior immunotherapy or certain other treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

\- Nivolumab 480 mg/every 4 weeks/IV infusion/6 cycles


Locations(1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

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NCT05795244


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