RecruitingPhase 1Phase 2NCT04014530

Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study

Study of Pembrolizumab Combined With Ataluren In Patients With Metastatic pMMR and dMMR Colorectal Adenocarcinomas or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

47 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Single Center, open label, Phase I-II trial designed to test the safety and efficacy of the combination of Ataluren and Pembrolizumab for the treatment of metastatic mismatch repair deficient and proficient colorectal adenocarcinoma and metastatic mismatch repair deficient endometrial carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pembrolizumab (an immunotherapy) and ataluren (a drug that helps the body read through certain genetic errors) — for people with metastatic colorectal cancer or endometrial (uterine) cancer. It focuses on patients with specific genetic markers in their tumors (pMMR or dMMR). **You may be eligible if...** - You are 18 or older - You have metastatic colorectal cancer and have received at least one prior chemotherapy regimen, OR you declined palliative chemotherapy - OR you have metastatic endometrial cancer with a dMMR genetic marker - You have measurable disease on imaging - You have a life expectancy greater than 3 months - Your organ function is adequate - You are willing to provide a tumor biopsy sample **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You have had prior treatment with pembrolizumab or similar immunotherapy - You have severe liver or kidney dysfunction - You are pregnant or breastfeeding 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

DRUGAtaluren + Pembrolizumab

Ataluren and Pembrolizumab combination therapy


Locations(1)

Amsterdam UMC, AMC

Amsterdam, North Holland, Netherlands

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NCT04014530


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