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NCT02989714 · ClinicalTrials.gov registry record · Phase 1

Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer

A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT02989714: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.

NCT02989714 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02989714, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in combination with Nivolumab. Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate, complete response rate, and improved survival outcomes compared to either of the individual therapies.

Primary Outcome

This is the primary outcome for the Phase Ib portion of the trial. Events of interest are possibly immune-mediated and occur only after at least one dose of Nivolumab has been administered. Immune-mediated events of interest do not include those that are known to occur during high dose IL-2 monotherapy and are reversible. Grade assessed per CTCAE version 4.0.

Interventions

  • DRUG Nivolumab
  • DRUG Interleukin-2

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2017-03-16
Est. Completion 2020-06-23
Phase Phase 1

What the finished NCT02989714 record still lists

NCT02989714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT02989714 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02989714 about?

NCT02989714 is a clinical study titled "Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer". This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in combination with Nivolumab. In...

What is the current status of trial NCT02989714?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-03-16. Estimated completion is 2020-06-23.

What interventions are being tested in trial NCT02989714?

The interventions under investigation include: Nivolumab (DRUG), Interleukin-2 (DRUG).

Who is sponsoring clinical trial NCT02989714?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02989714's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02989714, the US trial registry maintained by the National Library of Medicine. NCT02989714 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.