Pembrolizumab Before Surgery for the Treatment of Mismatch Repair Deficient Locally Advanced Solid Cancers
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|ClinicalTrials.gov Identifier: NCT04082572|
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : March 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Malignant Solid Neoplasm||Biological: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Pembrolizumab for Patients With Mismatch Repair Deficient Locally Advanced Solid Cancers|
|Actual Study Start Date :||September 17, 2019|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2025|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not respond to pembrolizumab and stop the treatment after 2 doses may undergo surgery within 6 months.
- Pathological complete response (pCR) [ Time Frame: 1 year ]Will estimate the pCR rate among the group of patients who receive at least 3 doses of pembrolizumab and undergo surgical resection (the primary endpoint). Those who do not undergo surgical resection will be classified as non-pCR for the intention to treat analysis. Pathological complete response will also be estimated for all patients who receive at least 1 dose of pembrolizumab (intent to treat). Estimated with 95% confidence interval.
- Rate of organ sparing [ Time Frame: At 1 year ]Defined as the rate of primary tumor control and no metastatic disease. Will be assessed for all patients who receive at least 1 doses of neoadjuvant pembrolizumab for the intention to treat analysis. In addition, the organ sparing rate at 1 year will be estimated among the group of patients who receive at least 3 doses of neoadjuvant pembrolizumab and do not undergo surgical resection.
- Incidence of adverse events [ Time Frame: Up to 2 years ]Safety will be recorded according to Common Terminology Criteria for Adverse Events toxicity and also post-operative complications will be classified according to Clavien-Dindo classification1.
- Overall survival [ Time Frame: From treatment start till death or last follow-up, assessed up to 2 years ]Will be estimated using the method of Kaplan and Meier.
- Relapse-free survival [ Time Frame: From the date of response to the date of documented treatment failure, relapses or death from any cause, whichever occurs first, assessed up to 2 years ]Defined as the number of days from the date of response to the date of documented treatment failure, relapses or death from any cause, whichever occurs first. Will be estimated using the method of Kaplan and Meier.
- Tumor response [ Time Frame: Up to 2 years ]The association between response (e.g. pathological complete response) and patient's clinical characteristics, such as changes in circulating tumor deoxyribonucleic acid, mutation burden, T-effector cell populations, gene expression profiles, etc. will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082572
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Michael J. Overman 713-792-2828 email@example.com|
|Principal Investigator: Michael J. Overman|
|Principal Investigator:||Michael J Overman||M.D. Anderson Cancer Center|