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โ† Trials
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Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer

RecruitingPhase 2Ages 18 Years - anyAllSolstice Oncology, Inc.
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if giving two medicines together, porustobart and pembrolizumab, before surgery can treat a common type of colon cancer called microsatellite stable (MSS) colon cancer in adults. This type of cancer can be removed with surgery and has not spread to other parts of the body. Both medicines work by helping the immune system fight cancer. The main questions this study wants to answer: How well do the medicines destroy the cancer before surgery? What side effects do participants have when taking the medicines? Researchers will compare two groups to see which treatment schedule works better and is safer. Both groups get pembrolizumab. One group gets one dose of porustobart (Day 1 only), and the other group gets two doses (Day 1 and Day 22). Participants will: Complete certain tests and procedures to make sure they are eligible Get the medicines

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: โ‰ฅ18 years of age at consent Adenocarcinoma of the colon (rectosigmoid considered non-rectal); pMMR/MSS status Any T3 or T4, N any, M0; disease amenable to surgical resection ECOG Performance Status 0-1 Adequate tumor tissue sample with associated pathology report Adequate hematologic, hepatic, and renal function Reproductive status/contraception requirements per protocol Exclusion Criteria: Investigational agent within 3 weeks of first dose Imminent or urgent need for surgery Prior treatment with ICIs targeting CTLA-4, PD-1, or PD-L1 Systemic corticosteroid/immunosuppressive therapy within 1 week of first dose (exceptions apply) History of severe hypersensitivity to a fully human mAb; interstitial lung disease; pneumonitis requiring corticosteroids Active or history of autoimmune disease requiring systemic treatment within 2 years Major surgery within 4 weeks of first dose; active infection requiring treatment
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What it tests

  • Pembrolizumab
  • Porustobart
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Where

30 sites
Investigator Site
Los Angeles, United States
Investigator Site
Tampa, United States
Investigator Site
Chicago, United States
Investigator Site
Baltimore, United States
Investigator Site
Boston, United States
Investigator Site
New York, United States
Investigator Site
New York, United States
Investigator Site
New York, United States

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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