Back to search results

Isunakinra and Pembrolizumab for Metastatic Colorectal Cancer

This study is for people with advanced colorectal cancer that has spread (metastatic). Your tumor must be microsatellite stable (MSS), have a high tumor mutational burden (TMB-H), and have a KRAS mutation. You must have already tried other approved treatments. Researchers are testing a new immunotherapy called isunakinra, which blocks a protein called IL-1, in combination with an already approved immunotherapy called pembrolizumab (a PD-1/PD-L1 inhibitor). The goal is to see if this combination can help treat this type of cancer, which is often hard to treat. The study will look at how safe the treatment is and how long people live without their cancer getting worse.

Study design
This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and how long people live without their cancer getting worse (PFS) for 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06634875

Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Buzzard Pharmaceuticals
~20 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:isunakinra

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety
Measured over 6 months
+1 more outcome measured

Conditions

Colorectal Cancer Metastatic

Explore related trials

Colorectal CarcinomaMSI1 GeneRAS Family OncogeneTPM2 wt Allele

Where it's being run

2 sites across 1 states
California2

Who to contact

Maarten de Chateau, MD PhD
[email protected]
+46 763 103031
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

1\. Subjects must have:
Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum
Tumor is determined to be RAS-mutated (KRAS, NRAS or HRAS) and microsatellite stable/proficient in mismatch repair, as assessed by immunohistochemistry (IHC) and/or polymerase chain reaction (PCR)/next generation sequencing (NGS) in a Clinical Laboratory Improvement Act (CLIA) environment and with a tumor mutational burden (TMB) of 10 MB or more.
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 8. Patients must have baseline pulse oximetry \> 90% on room air at rest.

Exclusion

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 8. Patients must have baseline pulse oximetry \> 90% on room air at rest.

What this trial measures

  • Safety6 months

    The incidence, relatedness and severity of adverse events (includes safety laboratory abnormalities) per CTCAE v. 5

  • PFS6 months

    Progression Free Survival per iRECIST