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NCT01608594 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma

A Phase 1 study of Melanoma, sponsored by Diwakar Davar.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT01608594: Completed Phase 1 study of Melanoma, sponsored by Diwakar Davar.

NCT01608594 is a Phase 1 study of Melanoma that has completed, run by Diwakar Davar. The registered enrollment target is 30 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% 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

NCT01608594, a Phase 1 study of Melanoma, has completed, sponsored by Diwakar Davar.

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

Study Summary

The purpose of this study is to evaluate the safety and potential effectiveness of a new treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better understand this disease, how best to treat it and what patients should be treated with this combination.

Primary Outcome

To estimate the safety profile of investigational combination biotherapy with standard HDI and ipilimumab at 10 mg/kg and 3 mg/kg

Conditions Studied

Interventions

  • DRUG administration of ipilimumab10mg/kg
  • DRUG administration of ipilimumab 3mg/kg + HDI

Study Locations (1)

Pennsylvania

  • UPMC Hillman Cancer Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2013-05-21
Est. Completion 2017-02-27
Phase Phase 1
Diwakar Davar

12 total trials

What the finished NCT01608594 record still lists

NCT01608594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which administration of ipilimumab10mg/kg is the first listed.

NCT01608594 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01608594 about?

NCT01608594 is a clinical study titled "Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma". The purpose of this study is to evaluate the safety and potential effectiveness of a new treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better understand this disease, how bes...

What is the current status of trial NCT01608594?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-05-21. Estimated completion is 2017-02-27.

What conditions does trial NCT01608594 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT01608594?

The interventions under investigation include: administration of ipilimumab10mg/kg (DRUG), administration of ipilimumab 3mg/kg + HDI (DRUG).

Who is sponsoring clinical trial NCT01608594?

This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01608594 being conducted?

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

Similar trials for Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01608594's enrollment target sits among peer trials

30 197th of 266 higher than 63 of 266 other Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Melanoma 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 NCT01608594, the US trial registry maintained by the National Library of Medicine. NCT01608594 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.