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Not yet recruitingPhase 2

Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer

A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR/MSS Colon Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: Complete certain tests and procedures to make sure they are eligible Get the medicines through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests porustobart and pembrolizumab before surgery in adults with a type of colon cancer called pMMR/MSS that has not spread to distant parts of the body and can be removed by surgery. Both medicines help the immune system fight cancer. Researchers will compare one or two doses of porustobart with pembrolizumab to see how well they destroy cancer and what side effects they cause.

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 through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when you agree to join.
  • Have colon adenocarcinoma, a cancer that starts in gland cells, with the pMMR/MSS test result.
  • Have cancer that has grown through the colon’s muscle layer or farther (T3 or T4), but has not spread to distant parts of the body, and can be removed by surgery.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Provide enough tumor tissue for testing, with a report about the sample.
  • Have blood counts and liver and kidney function that meet study requirements.
  • Meet the study’s rules about reproductive health and birth control.

Who can't join

  • Received an experimental drug within 3 weeks before the first study dose.
  • Need surgery right away or urgently.
  • Previously received immune treatments that target CTLA-4, PD-1, or PD-L1.
  • Used steroids or medicines that weaken the immune system and act throughout the body within 1 week before the first dose. Some exceptions apply.
  • Have a history of a severe allergic reaction to a fully human monoclonal antibody, a type of lab-made immune protein.
  • Have interstitial lung disease, which affects tissue around the lungs’ air sacs, or a history of lung inflammation that needed steroids.
  • Have or had an autoimmune disease, in which the immune system attacks the body, that needed treatment acting throughout the body within the past 2 years.
  • Had major surgery within 4 weeks before the first dose, or have an active infection that needs treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: ≥18 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

Study sites (11)

CA

FL

IL

MA

MD

NY

OH

TN

WA