Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Solstice Oncology, Inc.
Study ID
NCT07808151
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colon Cancer
  • Microsatellite Stable (MSS) Colon Cancer
  • Proficient Mismatch Repair (pMMR) Colon Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Administered to: Arm 1, Arm 2
  • Porustobart — DRUG
    Administered to: Arm 1, Arm 2

Study Details

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

Key Dates

First listed
Sep 8, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Pembrolizumab IV every 3 weeks x 2 doses (Day 1, Day 22) plus porustobart x 1 dose (Day 1 only)
  • Experimental: Arm 2
    Pembrolizumab IV every 3 weeks x 2 doses (Day 1, Day 22) plus porustobart every 3 weeks x 2 doses (Day 1, Day 22)

Primary Outcome Measure

Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR) [ Time Frame: Assessed from surgical resection specimen (surgery occurs Day 42-Day 63, i.e., approximately Week 6-Week 9 after first dose) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Investigator SiteLos AngelesCalifornia90033-
Investigator SiteTampaFlorida33612-
Investigator SiteChicagoIllinois60637-
Investigator SiteBaltimoreMaryland21287-
Investigator SiteBostonMassachusetts02114-
Investigator SiteNew YorkNew York10016-
Investigator SiteNew YorkNew York10021-
Investigator SiteNew YorkNew York10027-
Investigator SiteClevelandOhio44106-
Investigator SiteNashvilleTennessee37232-
Investigator SiteSeattleWashington98109-

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