OncoMatch/Clinical Trials/NCT06634875
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
Is NCT06634875 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT06634875 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent disqualifies patients from enrollment.
Does this trial require HRAS?
Yes, HRAS mutation is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages