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Monoclonal Antibodies

Combination Therapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Anna Spreafico
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be >= 18 years of age
Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable or recurrent
Must not have
Antineoplastic systemic chemotherapy or biological therapy
Participants who have had prior organ transplants (i.e. renal, lung, heart) due to the potential for increased rejection with immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30-37 days post treatment
Awards & highlights

Summary

This trial is studying the side effects and best dose of anetumab ravtansine when given with nivolumab, ipilimumab, and gemcitabine hydrochloride to treat patients with mesothelin positive pancreatic cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, organ inflammation due to immune response, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as low counts of different cell types increasing infection risk. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My pancreatic cancer has spread, cannot be removed by surgery, or has come back.
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I have tried at least one systemic therapy and it didn't work or I couldn't tolerate it.
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I have at least one tumor that can be measured on a CT or MRI scan.
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I am fully active or have minor restrictions in physical activity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving or have received chemotherapy or biological therapy.
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I have had an organ transplant.
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I am currently undergoing or have completed radiation therapy.
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I have or had inflammatory bowel disease like ulcerative colitis.
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I have had an autoimmune disease in the last 2 years.
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I haven't had significant bleeding issues in the last month.
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I experience significant numbness, pain, or weakness in my hands or feet.
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I have not received any live vaccines in the last 30 days.
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I do not have serious heart problems like uncontrolled high blood pressure or heart failure.
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I have not taken strong medication inhibitors or inducers, or consumed grapefruit/juice that affects drug metabolism in the last 2 weeks.
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I do not have an active infection needing IV drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30-37 days post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30-37 days post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Biomarker analysis

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pancreatic Adenocarcinoma include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like gemcitabine work by interfering with the DNA replication of cancer cells, thereby inhibiting their growth and division. Targeted therapies, such as Anetumab Ravtansine, use monoclonal antibodies to specifically target cancer cells expressing certain proteins like mesothelin, delivering cytotoxic agents (e.g., DM4) directly to the tumor cells to kill them. Immunotherapies, including nivolumab and ipilimumab, enhance the body's immune response against cancer cells by blocking inhibitory pathways that prevent immune cells from attacking the tumor. These treatments are crucial for Pancreatic Adenocarcinoma patients as they offer more precise and effective ways to combat the cancer, potentially improving survival rates and quality of life.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,327 Total Patients Enrolled
Anna SpreaficoPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
3 Previous Clinical Trials
243 Total Patients Enrolled

Media Library

Anetumab Ravtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03816358 — Phase 1
Pancreatic Adenocarcinoma Research Study Groups: Arm I (anetumab ravtansine, nivolumab), Arm II (anetumab ravtansine, nivolumab, ipilimumab), Arm III (anetumab ravtansine, nivolumab, gemcitabine)
Pancreatic Adenocarcinoma Clinical Trial 2023: Anetumab Ravtansine Highlights & Side Effects. Trial Name: NCT03816358 — Phase 1
Anetumab Ravtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03816358 — Phase 1
~7 spots leftby Jan 2025