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A phase 1/2 trial of cemiplimab in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.
Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07147231 by National Cancer Institute (NCI), with a registry enrolment figure of 86 participants, started 2026-08-10 and due to reach its primary completion in 2027-09-30. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Cemiplimab; Computed Tomography; Magnetic Resonance Imaging; Pidnarulex; Positron Emission Tomography. Conditions listed: Metastatic Colorectal Adenocarcinoma; Refractory Colorectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Adenocarcinoma. Primary outcome: Recommended phase 2 dose (RP2D) of pidnarulex (CX-5461) with anti-programmed cell death protein 1 (anti-PD-1) (Phase 1); Incidence of adverse events, serious adverse events, and dose limiting toxicities; Progression-free survival (PFS) (Phase II). Colorectal eligibility wording from the registry: "* Patients must have pathologically confirmed colorectal adenocarcinoma that is unresectable and/or metastatic and for which standard curative or palliative measures do not exist or are no longer effective". Sites: United States. No results are recorded here; the registry entry is the source.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Cemiplimab, Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
Shares Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot), Rectal cancer, Immune checkpoint inhibitors and the tag colorectal-deep-dive.
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