What side effects are associated with this type of intervention?

The most common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with several side effects. These include neutropenia, fatigue, neuropathy, nausea, and diarrhea. Specifically, gemcitabine can cause neutropenia, thrombocytopenia, and flu-like symptoms, while nab-paclitaxel is known for causing neuropathy and fatigue. When combined, these treatments can lead to increased rates of neutropenia, febrile neutropenia, and gastrointestinal issues. Patients undergoing these therapies should be closely monitored for these adverse effects to manage them effectively.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer include gemcitabine and nab-paclitaxel, which are commonly used in combination for first-line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC). This combination has shown significant improvements in survival and response rates compared to gemcitabine alone. While the NIS793 trial is exploring the addition of TGFβ blockade to this regimen, there are no specific FDA approvals for TGFβ inhibitors in pancreatic cancer treatment as of now. The focus remains on enhancing the efficacy of existing chemotherapy regimens.

What other types of research exist?

Promising alternatives to NIS793 for pancreatic cancer patients include: 1) Nanoliposomal Irinotecan in combination with Fluorouracil and Folinic Acid, which has shown efficacy as a second-line treatment. 2) Lenvatinib combined with Transarterial Chemoembolization, which has demonstrated positive results in advanced hepatocellular carcinoma and may have potential in pancreatic cancer. 3) Immunotherapy options such as Durvalumab combined with chemotherapy (e.g., gemcitabine and cisplatin) have also shown promise in other cancers and could be considered.

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Chemotherapy

NIS793 + Chemotherapy for Pancreatic Cancer

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Participants aged ≥18 years with histologically or cytologically confirmed mPDAC eligible for treatment in the first-line setting and not amenable for potentially curative surgery

Must not have

Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding

Pancreatic neuroendocrine (islet) or acinar tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 19 months

Awards & highlights

Summary

This trial is testing a new drug called NIS793 combined with two chemotherapy drugs in patients with advanced pancreatic cancer. The goal is to block a protein to reduce thick tissue around the cancer, making it more responsive to treatment and improving survival.

Who is the study for?

This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma (mPDAC) who haven't had treatment for metastatic cancer. They need at least one measurable tumor and good organ function. They can't join if they've had recent major surgery, significant heart disease, unhealed wounds, certain bleeding risks, or previous cancer treatments that still affect them.

What is being tested?

The study tests the effectiveness of NIS793 combined with standard chemotherapy drugs gemcitabine/nab-paclitaxel against a placebo plus the same chemo in treating mPDAC. It examines whether blocking TGFβ protein with NIS793 improves survival and response to chemo by reducing fibrosis in tumors.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue from treatment stress on the body, digestive issues due to drug impact on gut health, blood disorders affecting cell counts or clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 or older with pancreatic cancer not suitable for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that increases my risk of serious bleeding.

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I have a pancreatic neuroendocrine or acinar tumor.

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I have had treatment for metastatic pancreatic cancer before.

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I have wounds that are not healing properly.

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I do not have severe nerve damage in my hands or feet.

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My pancreatic cancer is known to be MSI-H or mismatch repair-deficient.

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I have heart problems or significant heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 19 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 19 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 19 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Randomized part: Overall survival (OS)

Safety run-in part: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.

Secondary study objectives

Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of NIS793 in combination with gemcitabine and nab-paclitaxel

Area under the curve from time zero to the last measurable concentration sampling time (AUClast) of NIS793 in combination with gemcitabine and nab-paclitaxel

Disease control rate (DCR) by investigator assessment per RECIST 1.1

+13 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Safety run-in part: NIS793+gemcitabine+nab-paclitaxelExperimental Treatment3 Interventions

In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.

Group II: Randomized part: NIS793+gemcitabine+nab-paclitaxelExperimental Treatment4 Interventions

Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Group III: Randomized part: placebo+gemcitabine+nab-paclitaxelPlacebo Group3 Interventions

Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

NIS793

2017

Completed Phase 1

~120

Nab-paclitaxel

2014

Completed Phase 3

~1950

Gemcitabine

2017

Completed Phase 3

~1920

0 / 9Eligibility 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 cancer include gemcitabine, nab-paclitaxel, and emerging therapies like TGFβ blockade. Gemcitabine is a nucleoside analog that inhibits DNA synthesis, leading to cell death, while nab-paclitaxel stabilizes microtubules, preventing cell division. These drugs are often used in combination to enhance their efficacy. TGFβ blockade, as studied in the NIS793 trial, aims to reduce fibrosis in pancreatic tumors, which can restore chemo-sensitivity and improve overall survival. These mechanisms are crucial for pancreatic cancer patients as they target the aggressive nature of the disease and aim to improve treatment outcomes.