NCT05197322: NEOPRISM-CRC

NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer

Recruiting now Phase 2 Last updated 17 April 2026

What this trial tests

Phase 2 trial testing Pembrolizumab in Adenocarcinoma of the Colon in 88 participants. Currently enrolling.

Timeline

20 July 2022

Primary endpoint
31 July 2026

31 July 2029

Quick facts

Lead sponsor	University College, London
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	20 July 2022
Primary completion	31 July 2026
Estimated completion	31 July 2029
Sites	6 locations across United Kingdom

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Adenocarcinoma of the Colon — all drugs for Adenocarcinoma of the Colon →

Sponsor

University College, London

Who can join

18 and older, any sex, with Adenocarcinoma of the Colon. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients. Even after surgery up to half of patients will develop recurrence or spread of the disease (metastases) which is incurable. Survival after 5 years is approximately 14% for patients with metastatic disease. Clinical trials using immunotherapy drugs called 'immune checkpoint inhibitors' have shown excellent results in advanced colorectal cancer patients who have certain genetic characteristics called 'mismatch repair deficiency (MMR-d)' and 'high microsatellite instability (MSI-h)'. The benefits of immunotherapy as a treatment prior to surgery to remove the tumour (neoadjuvant treatment) has been observed in both melanoma and in glioblastoma with enhanced local and systemic anti-tumour responses.

Pembrolizumab is an immunotherapy drug and works by helping the body's own immune system to fight the cancer cells. The NEOPRISM-CRC trial will investigate whether giving pembrolizumab before surgery is safe, whether it improves the chances of the tumour being removed completely and whether it delays or prevents the cancer from coming back.

Pembrolizumab treatment lasts for a maximum of 9 weeks (maximum of 3 cycles of treatment, each cycle consisting of 3 weeks) and is given prior to surgery. Following surgery patients will be followed up for at least 3 years after their surgery and to a maximum of 5 years. Target recruitment is 88 patients and recruitment is expected to take place over a 48 month period.

Blood, tissue, mouth swabs and stool samples will be collected from patients throughout the trial to better understand the biology of immunotherapy as a treatment for CRC prior to surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Translating the evolving molecular landscape of tumors to biomarkers of response for cancer immunotherapy.
   Anagnostou V, Landon BV, Medina JE, Forde P, et al · · 2022 · cited 38× · PMID 36350985 · DOI 10.1126/scitranslmed.abo3958
2. Clinical trials of neoadjuvant immune checkpoint inhibitors for early-stage operable colon and rectal cancer.
   Veen T, Kanani A, Lea D, Søreide K. · · 2023 · cited 21× · PMID 37528319 · DOI 10.1007/s00262-023-03480-w
3. Deficient Mismatch Repair and Microsatellite Instability in Solid Tumors.
   Awosika JA, Gulley JL, Pastor DM. · · 2025 · cited 6× · PMID 40362635 · DOI 10.3390/ijms26094394
4. Biology and evolving management of resectable dMMR/MSI-H cancers: current status and future perspectives.
   Tanegashima T, Shiota M, Toyosaki K, Funakoshi K, et al · · 2025 · cited 1× · PMID 41196394 · DOI 10.1007/s00262-025-04223-9
5. Treatment with checkpoint inhibitors for unresectable non-metastatic mismatch repair deficient intestinal cancer; a case series.
   Figaroa OJA, Spaanderman IT, Goedegebuure RSA, Cirkel GM, et al · · 2025 · cited 1× · PMID 40983668 · DOI 10.1038/s44276-025-00171-0
6. Case report: Efficacy of immunotherapy as conversion therapy in dMMR/MSI-H colorectal cancer: a case series and review of the literature.
   San-Román-Gil M, Martínez-Delfrade I, Albarrán-Fernández V, Guerrero-Serrano P, et al · · 2024 · cited 1× · PMID 38361927 · DOI 10.3389/fimmu.2024.1352262
7. Modelling Immune Dynamics in Locally Advanced MSI-H/dMMR Colorectal Cancer with Neoadjuvant Pembrolizumab Treatment: From Differential Equations to an Agent-Based Framework.
   Hawi G, Kim PS, Lee PP. · · 2026 · PMID 41627569 · DOI 10.1007/s11538-026-01594-7
8. Neoadjuvant immunotherapy leads to complete pathologic response in locally advanced colon cancer.
   Sandow L, Tsikitis L, Lopez CD, Brinkerhoff B, et al · · 2024 · PMID 39114842 · DOI 10.1002/ccr3.9218