← Back to Search

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 whether NIS793, a TGFβ blocker, can help gemcitabine/nab-paclitaxel work better against pancreatic cancer.

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.Check my eligibility
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.See study design
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
Select...
I am fully active or can carry out light work.
Select...
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:
Select...
I have a condition that increases my risk of serious bleeding.
Select...
I have a pancreatic neuroendocrine or acinar tumor.
Select...
I have had treatment for metastatic pancreatic cancer before.
Select...
I have wounds that are not healing properly.
Select...
I do not have severe nerve damage in my hands or feet.
Select...
My pancreatic cancer is known to be MSI-H or mismatch repair-deficient.
Select...
I have heart problems or significant heart disease.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
~2030
Gemcitabine
2017
Completed Phase 3
~2070

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.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,480 Total Patients Enrolled

Media Library

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04935359 — Phase 3
Pancreatic Cancer Research Study Groups: Randomized part: placebo+gemcitabine+nab-paclitaxel, Safety run-in part: NIS793+gemcitabine+nab-paclitaxel, Randomized part: NIS793+gemcitabine+nab-paclitaxel
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04935359 — Phase 3
Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04935359 — Phase 3
~0 spots leftby Aug 2024