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About
This phase I/II trial studies the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) or that cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells.
Full description
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab.
II. To estimate the 6-month progression free survival (PFS) rate of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab.
III. To examine the adverse event profile of combining pembrolizumab and cetuximab.
SECONDARY OBJECTIVES:
I. To examine the PFS of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab.
II. To determine the objective response rate by immune-related response criteria (irRC) of patients with metastatic colorectal cancer.
III. To examine the overall survival of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab.
EXPLORATORY OBJECTIVES:
I. Identify tumor and peripheral blood biomarkers of response and/or resistance to the study treatment.
OUTLINE:
Patients receive cetuximab intravenously (IV) over 120 minutes on day 1, 8, and 15 (as monotherapy for cycle 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
After completion of the study treatment, patients are followed up every 3 months for up to 2 years.
Enrollment
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Inclusion criteria
Have a pathologically confirmed diagnosis of colorectal cancer, which is metastatic or otherwise unresectable
Have received at least 1 prior systemic therapy in the metastatic or unresectable disease setting; patients who have recurred within six months of adjuvant chemotherapy are not required to have received an additional line of chemotherapy
Retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS) wild-type; v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) testing must be completed, with full KRAS and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) testing strongly advised; the presence of known mutations in KRAS or NRAS is exclusionary; primary tumor or metastatic tumor may be tested; (note: in the case of multiple genomic evaluations with conflicting results - e.g. KRAS mutant in one sample, but wild-type in another - the patient may be included as RAS wild-type, if clinically justified, after review with the principal investigator [PI])
Appropriate for anti-EGFR therapy: Naive to anti-EGFR therapy (cetuximab or panitumumab) or a candidate for rechallenge by virtue of the following:
Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on day 1
Hemoglobin >= 8 g/dL (performed within 14 days of treatment initiation)
Absolute neutrophil count >= 1000/mm3 (performed within 14 days of treatment initiation)
Platelet count >= 100,000/mm3 (performed within 14 days of treatment initiation)
Serum creatinine =< 2 upper limit of normal (ULN) or, >= 15 mL/min for participants with creatinine levels > 2 ULN (performed within 14 days of treatment initiation)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 ULN or, =< 5 ULN for participants with liver metastases (performed within 14 days of treatment initiation)
Female participants of childbearing potential are to have a negative serum pregnancy test
Female participants of child-bearing potential must agree to use an acceptable method of birth control, be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion criteria
Primary purpose
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45 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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