OncoMatch/Clinical Trials/NCT06634875
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
Is NCT06634875 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies isunakinra for colorectal cancer metastatic.
Treatment: isunakinra — This study will enroll patients with colorectal cancer that is locally advanced or metastatic. The tumor must be microsatellite stable (MSS), have a tumor mutational burden that is high (TMB-H) and be kras mutated. Patients must have been treated with available approved treatments already. In this study the investigators are testing a new type of immunotherapy, the potent IL-1 inhibitor isunakinra to be added to already approved immunotherapy (PD-1/PD-L1 inhibitor) in an attempt to get this treatment to work in this treatment resistant type of tumor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: HRAS mutation
Required: KRAS mutation
Required: NRAS mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: disease-appropriate therapy for metastatic disease — metastatic
Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease (with or without PD-1 inhibitors), with no available therapy likely to convey clinical benefit, or not be candidates for therapy of proven efficacy for their disease.
Cannot have received: investigational agent
Patients who are receiving any other investigational agents within 28 days before start of study treatment.
Lab requirements
Blood counts
Granulocyte count ≥ 1,500/mm3; Platelet count ≥ 75,000/mm3
Kidney function
Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL/min.
Liver function
ALT and AST ≤ 3x the upper limits of normal. Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.
Patients must have normal organ and hematologic function as defined below: * Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL/min. * ALT and AST ≤ 3x the upper limits of normal. * Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0. * Hematological eligibility parameters (within 16 days of starting therapy): * Granulocyte count ≥ 1,500/mm3 * Platelet count ≥ 75,000/mm3
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC/Norris Cancer Center · Los Angeles, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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