Neoadjuvant pembrolizumab and porustobart for resectable MSS colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates using two immune therapies before surgery for adults with resectable pMMR/MSS colon cancer. All participants receive pembrolizumab, with one group getting a single porustobart dose on day 1 and the other group receiving doses on day 1 and day 22. The study aims to measure how well the treatment reduces tumor burden prior to surgery and to monitor safety and side effects. Participants will receive intravenous therapy on specified days, undergo standard pre-surgical assessments, and have surgery about 6–9 weeks after starting treatment. Outcomes will compare efficacy and safety between the two dosing schedules.

Why it matters

Who can join: the full rules

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

Where it's running

• Investigator Site
  Los Angeles, California, United States Recruiting
• Investigator Site
  Cleveland, Ohio, United States Recruiting
• Investigator Site
  Seattle, Washington, United States Recruiting
• Investigator Site
  Tampa, Florida, United States Not yet recruiting
• Investigator Site
  Chicago, Illinois, United States Not yet recruiting
• Investigator Site
  Baltimore, Maryland, United States Not yet recruiting

Study contacts

• Study coordinator: Medical Monitor
• Email: SOL1-201@solsticeoncology.com
• Phone: 617-982-2331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.