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Monoclonal Antibodies
Axatilimab + Retifanlimab + Paclitaxel for Cancer
Phase 1 & 2
Recruiting
Led By Shivaani Kummar
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to end of treatment visit (an average of 6 months)
Awards & highlights
Summary
"This trial is testing a combination of three drugs - axatilimab, retifanlimab, and paclitaxel - for treating patients with advanced or metastatic solid tumors.
Who is the study for?
This trial is for patients with advanced or metastatic solid tumors. Participants should have a tumor that has spread from its original site to other body parts. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.
What is being tested?
The trial is testing the combination of axatilimab, retifanlimab (both monoclonal antibodies), and paclitaxel (a chemotherapy drug) on patients with solid tumors. It aims to see if this mix can safely and effectively stop cancer growth by helping the immune system attack the cancer cells.
What are the potential side effects?
Potential side effects may include reactions related to the immune system's enhancement such as inflammation in various organs, infusion-related reactions due to antibody administration, fatigue from treatment burden, digestive issues caused by chemotherapy drugs like paclitaxel, and an increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening to end of treatment visit (an average of 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to end of treatment visit (an average of 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit rate (phase Ib/II)
Incidence of dose limiting toxicities (phase Ib)
Secondary outcome measures
Change in immune cell population
Changes in immune cell composition and functionality
Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (axatilimab, retifanlimab, paclitaxel)Experimental Treatment8 Interventions
Patients receive axatilimab IV over 30 minutes on day -8, prior to cycle 1. Beginning in cycle 1 day 1, patients receive axatilimab IV over 30 minutes on days 8 and 21 of each cycle, retifanlimab IV over 30-60 minutes on day 1 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy, CT scan, and blood sample collection at screening and on study and may undergo MRI and/or PET scan at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axatilimab
2017
Completed Phase 1
~50
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Paclitaxel
2011
Completed Phase 4
~5810
Biospecimen Collection
2004
Completed Phase 3
~2020
Positron Emission Tomography
2011
Completed Phase 2
~2200
Retifanlimab
2018
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
994 Previous Clinical Trials
7,386,910 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
57,014 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
234 Previous Clinical Trials
2,088,589 Total Patients Enrolled
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