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NCT02748564 · ClinicalTrials.gov registry record · Phase 2

Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

A Phase 2 study, sponsored by Rutgers, The State University of New Jersey.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT02748564: Clinical Trial Phase 2 study, sponsored by Rutgers, The State University of New Jersey.

NCT02748564 is a Phase 2 study that was terminated before completion, run by Rutgers, The State University of New Jersey. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02748564, a Phase 2 study, was terminated before completion, sponsored by Rutgers, The State University of New Jersey.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

This study will evaluate the safety and tolerability of IL-2 when given in combination with pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more tumor cells. There are two parts to this study: * Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in combination with pembrolizumab * Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients will be treated to determine if it is effective against the cancer.

Primary Outcome

Estimated using OTD of IL-2 and pembrolizumab assessed by Response Evaluation Criteria in Solid Tumors version 1.1,for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for P

Interventions

  • BIOLOGICAL Pembrolizumab
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Aldesleukin

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-03-21
Est. Completion 2023-06-05
Phase Phase 2

Why NCT02748564 stopped before completion

NCT02748564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT02748564 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02748564 about?

NCT02748564 is a clinical study titled "Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma". This study will evaluate the safety and tolerability of IL-2 when given in combination with pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to ...

What is the current status of trial NCT02748564?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-03-21. Estimated completion is 2023-06-05.

What interventions are being tested in trial NCT02748564?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Aldesleukin (BIOLOGICAL).

Who is sponsoring clinical trial NCT02748564?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02748564's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02748564, the US trial registry maintained by the National Library of Medicine. NCT02748564 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.