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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 19 months
Awards & highlights

Study 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
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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.

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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,839 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has NIS793 been cleared by the FDA for public consumption?

"Similar to other Phase 3 trials, NIS793's safety has been evaluated by our team and given a score of 3."

Answered by AI

What are NIS793's most popular applications?

"NIS793 is most often used to treat neoplasm metastasis, but it can also be given to patients with locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary bladder cancer."

Answered by AI

At how many hospitals is this research being conducted?

"There are a total of 16 sites for this clinical trial. They are: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Can C in New york, New York, Mount Sinai School of Medicine in Columbia, Missouri, University of Missouri in Seattle, Washington, and 13 other locations."

Answered by AI

What goals do researchers hope to achieve with this experiment?

"The primary outcome of this trial is overall survival, which will be assessed over a period of up to 4 weeks. Secondary outcomes include time-to-deterioration in domain scores in the PROMIS-29 profile and change from baseline in the patient reported outcomes measurement information system (PROMIS)-29 profile scores at week 12."

Answered by AI

Are you currently looking for participants in this clinical trial?

"That is correct. The online clinicaltrials.gov database has information indicating that this research project is still looking for patients. The trial was originally announced on September 30th, 2021 and was updated on October 24th, 2022. So far, 13 hospitals have agreed to take part in the study and 501 total patients are desired."

Answered by AI

How many individuals are being given this opportunity to participate in this clinical trial?

"That is correct, the online clinicaltrials.gov registry currently has this study listed as recruiting patients. The 501 planned participants will be drawn from 13 different study sites. The trial was originally posted on September 30th, 2021."

Answered by AI

Is NIS793 being trialled for other medical purposes?

"NIS793 was first trialed in 1997 at City of Hope Comprehensive Cancer Center. As of now, there are 1166 active clinical trials and 20017 completed ones. A great many of these studies are based in New york, New York."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
US Oncology Research, Dallas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
2021. "Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04935359.
~32 spots leftby Jun 2024
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