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NCT03697564 · ClinicalTrials.gov registry record · Phase 2

Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer

A Phase 2 study of Pancreatic Cancer Stage IV, sponsored by Hitendra Patel.

Completed
Registry status
Phase 2
Development phase
2
Enrollment target
1
Study location

NCT03697564: Completed Phase 2 study of Pancreatic Cancer Stage IV, sponsored by Hitendra Patel.

NCT03697564 is a Phase 2 study of Pancreatic Cancer Stage IV that has completed, run by Hitendra Patel. The registered enrollment target is 2 participants, below the 272-participant average among 3 other Pancreatic Cancer Stage IV trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03697564, a Phase 2 study of Pancreatic Cancer Stage IV, has completed, sponsored by Hitendra Patel.

COMPLETED
Registry status
Phase 2
Development phase
2 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.

Primary Outcome

To estimate Progression Free Survival (PFS rates) at 6 months per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Conditions Studied

Pancreatic Cancer Stage IV

Interventions

  • DRUG Gemcitabine
  • DRUG Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
  • DRUG Cabiralizumab

Study Locations (1)

California

  • UCSD Moores Cancer Center - La Jolla

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2019-10-31
Est. Completion 2023-07-13
Phase Phase 2
Hitendra Patel

1 total trials

What the finished NCT03697564 record still lists

NCT03697564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 272-participant average among 3 other Pancreatic Cancer Stage IV trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Pancreatic Cancer Stage IV appearing as the primary indexed condition, and to 3 interventions - of which Gemcitabine is the first listed.

NCT03697564 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT03697564 about?

NCT03697564 is a clinical study titled "Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer". The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.

What is the current status of trial NCT03697564?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2019-10-31. Estimated completion is 2023-07-13.

What conditions does trial NCT03697564 study?

This clinical trial studies the following conditions: Pancreatic Cancer Stage IV.

What interventions are being tested in trial NCT03697564?

The interventions under investigation include: Gemcitabine (DRUG), Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] (DRUG), Cabiralizumab (DRUG).

Who is sponsoring clinical trial NCT03697564?

This trial is sponsored by Hitendra Patel, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03697564 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT03697564, the US trial registry maintained by the National Library of Medicine. NCT03697564 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.