ClinicalTrials.gov
Cure8 trial brief
Why This Matters
People with IBD sometimes are excluded from or uncertain about immune checkpoint inhibitor cancer trials because of concerns about triggering autoimmune flares. This trial explicitly studies safety and disease impact in patients with IBD, which could inform future treatment decisions for patients who develop cancer.
Who Should Pay Attention
Adults with IBD (ulcerative colitis or Crohn’s disease), clinicians who treat IBD and oncology patients, and researchers studying immunotherapy safety in autoimmune disease.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1
Enrollment300 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes a multi-arm phase Ib study (AIM-NIVO) enrolling patients with a range of autoimmune disorders and advanced or unresectable cancers. Nivolumab is being studied as monotherapy and in combination with FDA‑approved cancer regimens such as ipilimumab, cabozantinib, and chemotherapy (platinum agents, fluoropyrimidines).
The trial lists IBD (ulcerative colitis and Crohn’s disease) among the autoimmune conditions of interest and includes objectives to measure safety/toxicity, anti-tumor activity, effects on autoimmune disease severity, and biomarkers.
Enrollment and design notes: The study is interventional, phase 1b, and assigns patients to multiple arms depending on cancer type and treatment combination. Primary outcomes focus on safety/toxicities; secondary outcomes include objective response, progression-free and overall survival, and biomarker identification. The record does not report results.
Keep In Mind
This is a clinicaltrials.gov trial record describing a recruiting phase Ib study; no trial results are reported in this record. Enrollment includes many autoimmune diseases and multiple cancer treatment arms, so findings specific to IBD will depend on how many patients with IBD enroll and on later reported outcomes.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorNational Cancer Institute (NCI)
Trial IDNCT03816345
Study typeInterventional
Trial phasePhase 1
Enrollment300 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 31, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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