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NCT03284424 · ClinicalTrials.gov registry record · Phase 2

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)

A Phase 2 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 2
Development phase
159
Enrollment target

NCT03284424: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.

NCT03284424 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03284424, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 2
Development phase
159 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

Primary Outcome

ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented.

Interventions

  • BIOLOGICAL Pembrolizumab

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2017-10-26
Est. Completion 2023-09-13
Phase Phase 2
Merck Sharp & Dohme

558 total trials

What the finished NCT03284424 record still lists

NCT03284424 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).

The record links to 0 conditions, and to 1 intervention - of which Pembrolizumab is the first listed.

NCT03284424 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03284424 about?

NCT03284424 is a clinical study titled "Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)". The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic the...

What is the current status of trial NCT03284424?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2017-10-26. Estimated completion is 2023-09-13.

What interventions are being tested in trial NCT03284424?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03284424?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03284424's enrollment target sits among peer trials

159 442nd of 2000 higher than 1,558 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 NCT03284424, the US trial registry maintained by the National Library of Medicine. NCT03284424 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.