Trial Summary
What is the purpose of this trial?
This trial tests a combination of therapies in patients with advanced pancreatic cancer. The treatment aims to kill cancer cells directly, boost the immune system, and stop cancer growth. It focuses on patients whose cancer has spread and may not respond to standard treatments.
Research Team
Anna Spreafico, MD PhD
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Eligibility Criteria
This trial is for adults with advanced pancreatic cancer that has spread and can't be removed by surgery. Participants must have tried at least one treatment before, have tumors expressing a protein called mesothelin, and be in good physical condition (ECOG score 0-1). They should not have untreated brain metastases or certain infections like HIV or hepatitis B/C. Women who can bear children and men with partners of childbearing potential must use effective contraception.Inclusion Criteria
Your albumin levels in the blood need to be at least 2.5 mg/dL or higher.
Your hemoglobin level is 9 grams per deciliter or higher.
My cancer has grown in an area previously treated with radiation, and the growth can be measured.
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Exclusion Criteria
I have not had major surgery in the last 4 weeks.
I have a corneal condition or other eye issues as diagnosed by my eye doctor.
I am currently receiving or have received chemotherapy or biological therapy.
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Treatment Details
Interventions
- Anetumab Ravtansine (Monoclonal Antibodies)
- Gemcitabine Hydrochloride (Anti-metabolites)
- Ipilimumab (Monoclonal Antibodies)
- Nivolumab (Monoclonal Antibodies)
Trial OverviewThe study tests anetumab ravtansine combined with nivolumab, ipilimumab, or gemcitabine to see which works best against pancreatic cancer. Anetumab ravtansine targets cancer cells directly while the other drugs help the immune system fight the disease or stop tumor growth. The trial aims to find out the safest doses and how well these combinations work together.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Arm III (anetumab ravtansine, nivolumab, gemcitabine)Experimental Treatment5 Interventions
Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Patients also receive gemcitabine hydrochloride over 30-40 minutes on days 1 and 8. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy and collection of blood on study.
Group II: Arm II (anetumab ravtansine, nivolumab, ipilimumab)Experimental Treatment5 Interventions
Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Patients also receive ipilimumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of cycles 2-4. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy and collection of blood on study.
Group III: Arm I (anetumab ravtansine, nivolumab)Experimental Treatment4 Interventions
Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy and collection of blood on study.
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Trials
14,080
Recruited
41,180,000+