What side effects are associated with this type of intervention?

Common treatments for Pancreatic Adenocarcinoma, such as monoclonal antibodies combined with chemotherapy agents, often result in side effects including nausea, vomiting, fatigue, and elevated aminotransferase levels. Specific treatments like gemcitabine can cause hematologic toxicities such as neutropenia and anemia, while immunotherapy agents like nivolumab and ipilimumab may lead to immune-related adverse events such as skin rash, diarrhea, and infusion-related reactions. These side effects are generally manageable but require careful monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Pancreatic Adenocarcinoma, including combination therapies and monoclonal antibodies. Notably, gemcitabine in combination with nab-paclitaxel has shown significant efficacy, improving overall survival and response rates compared to gemcitabine alone. Immunotherapy agents like pembrolizumab, a PD-1 inhibitor, have also been explored, particularly for tumors expressing PD-L1. While Anetumab Ravtansine specifically targets mesothelin positive cancer cells, other monoclonal antibodies and combination regimens involving chemotherapy and immunotherapy have been integral in advancing treatment options for this challenging malignancy.

What other types of research exist?

Promising novel alternatives for pancreatic adenocarcinoma treatment in 2024 include: 1) Nivolumab (anti-PD-1) combined with Ipilimumab (anti-CTLA-4) for enhanced immune response, 2) Larotrectinib for TRK fusion-positive tumors, and 3) Dabrafenib plus Trametinib for BRAFV600E-mutated tumors. These therapies have shown efficacy in clinical trials and represent advanced options for targeted and immunotherapy approaches.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30-37 days post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Biomarker analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2020

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Ipilimumab

2015

Completed Phase 3

~3070

Nivolumab

2015

Completed Phase 3

~4010

0 / 16Eligibility criteria met

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.