Colon Cancer, Microsatellite Stable (MSS) Colon Cancer, Proficient Mismatch Repair (pMMR) Colon Cancer
Conditions
Keywords
neoadjuvant therapy, Immune checkpoint inhibitor, CTLA-4, PD-1, Porustobart, HBM4003, Pembrolizumab, Major pathologic response, pMMR/MSS colon cancer, Resectable colon cancer, Fc-enhanced CTLA-4
Brief summary
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
Interventions
DRUGPembrolizumab
Administered to: Arm 1, Arm 2
DRUGPorustobart
Administered to: Arm 1, Arm 2
Sponsors
Solstice Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR) | Assessed from surgical resection specimen (surgery occurs Day 42-Day 63, i.e., approximately Week 6-Week 9 after first dose) | MPR is defined as the proportion of patients with ≤10% residual tumor volume in the primary tumor and lymph nodes, as evaluated by BIPR, per treatment arm |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response (pCR) rate | Assessed from surgical resection specimen (Week 6-9) |
| Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs), and immune-related AEs | From informed consent through 60 days after last dose (or initiation of new anti-cancer treatment, whichever occurs first) |
Countries
Belgium, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
CONTACTMedical Monitor
Outcome results
None listed