Clinical Trial Evaluating the Safety and Response With PF-05082566, Cetuximab and Irinotecan in Patients With Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03290937|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8||Biological: Cetuximab Drug: Irinotecan Drug: Irinotecan Hydrochloride Other: Pharmacodynamic Study Biological: Utomilumab||Phase 1|
I. To evaluate maximal tolerated dose (MTD), and recommended phase 2 dose (RP2D) of the combination of utomilumab (PF-05082566), cetuximab and irinotecan hydrochloride (irinotecan) (PCI) in patients with metastatic colorectal cancer refractory to standard therapy. (Dose escalation) II. To determine the antitumor activity overall response rate (ORR) by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) of PCI combination specifically in patients with advanced colorectal cancer who are RAS-RAF wild type (WT) (Arm A) or RAS mutant (Arm B). (Dose expansion)
I. To evaluate overall safety profile. II. To evaluate the anti-tumor activity. III. To evaluate pharmacodynamics (PD) biomarkers expressed by peripheral blood mononuclear cells (PBMC) and tissue samples.
IV. To characterize serum biomarkers linked to immunomodulation and cytokine release.
V. To assess markers of T and natural killer (NK) cell phenotype (such as CD3, CD4, CD8, FoxP3, CD14, CD33, CCR7, CD45RO, CD16, CD56, CD69, CD25, or VCAM1), TNF alpha, IFN gamma, IL10, IL-8, IL-6, IL-4, IL-2, IL-1b, or IL-12p70, CD127, Ki67, eomesodermin, KLRG1, CD14, CD33, human leukocyte antigen- D related (HLA-DR), CD16, CD56, granzyme B, CD68, PD-1, CD11c, sCD137, and 4-1BB.
OUTLINE: This is a dose escalation study of irinotecan hydrochloride.
Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and cetuximab IV over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial Evaluating the Safety and Response With PF-05082566, Cetuximab and Irinotecan in Patients With Advanced Colorectal Cancer|
|Actual Study Start Date :||December 27, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
Patients receive irinotecan hydrochloride IV over 90 minutes and cetuximab IV over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Irinotecan Hydrochloride
Other: Pharmacodynamic Study
Other Name: PHARMACODYNAMIC
- Recommended phase 2 dose of irinotecan hydrochloride [ Time Frame: Up to 4 years ]A modified 3+3 design will be used to determine the maximum tolerated dose.
- Incidence of adverse events [ Time Frame: Up to 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290937
|Contact: David S. Hong, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: David S. Hong 713-563-1930 firstname.lastname@example.org|
|Principal Investigator: David S. Hong|
|Principal Investigator:||David S Hong||M.D. Anderson Cancer Center|