Colon Cancer study: Pembrolizumab vs Porustobart
Official title Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
ClinicalTrials.gov ID: NCT07808151
What this study is testing
What is Pembrolizumab?
an investigational drug being studied as a potential treatment for microsatellite stable colon cancer before surgery is designed to block the PD-1 protein on immune cells, helping the immune system recognize and attack cancer cells
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out how well these medicines shrink the cancer before surgery and what side effects they cause. It also compares two different dosing schedules to see which is safer and more effective.
- Who it's for
- Adults with a common type of colon cancer that can be removed by surgery and has not spread to other parts of the body.
- What's involved
- Participants receive two immune-boosting medicines through a vein on Day 1 and Day 22. They then have surgery 6 to 9 weeks after starting treatment and undergo regular checkups and tests.
- Time commitment
- The study involves initial testing, treatment, surgery, and follow-up visits every 6 months for up to 3 years after surgery.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Baltimore, Maryland, United States
- Cleveland, Ohio, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Baltimore, Maryland, United States; Cleveland, Ohio, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.