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NCT04955743 · ClinicalTrials.gov registry record · Phase 2

Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma

A Phase 2 study, sponsored by Yale University.

Terminated
Registry status
Phase 2
Development phase
18
Enrollment target

NCT04955743: Clinical Trial Phase 2 study, sponsored by Yale University.

NCT04955743 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04955743, a Phase 2 study, was terminated before completion, sponsored by Yale University.

TERMINATED
Registry status
Phase 2
Development phase
18 participants
Enrollment target

Study Summary

This is a phase 2, Simon's 2-stage designed study with 2 cohorts of anti-PD-1/PD-L1 experienced patients with untreated brain metastases: 1) melanoma and 2) renal cell carcinoma (RCC).

Primary Outcome

Best brain metastasis response rate (BMRR), defined as PR (Partial Response: 30% or greater decrease in sum of diameter \[sum of longest dimension\]) and CR (Complete Response: disappearance of all target lesions) per modified RECIST 1.1. Tumor categories not included in BMRR include SD (Stable Disease: insufficient shrinkage to qualify for PR) and PD (Progressive Disease: 20% or greater increase in sum of diameter relative to the nadir (smallest sum recorded).

Interventions

  • DRUG Pembrolizumab
  • DRUG Lenvatinib

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2022-02-09
Est. Completion 2025-05-28
Phase Phase 2
Yale University

1,492 total trials

Why NCT04955743 stopped before completion

NCT04955743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

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

NCT04955743 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04955743 about?

NCT04955743 is a clinical study titled "Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma". This is a phase 2, Simon's 2-stage designed study with 2 cohorts of anti-PD-1/PD-L1 experienced patients with untreated brain metastases: 1) melanoma and 2) renal cell carcinoma (RCC).

What is the current status of trial NCT04955743?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2022-02-09. Estimated completion is 2025-05-28.

What interventions are being tested in trial NCT04955743?

The interventions under investigation include: Pembrolizumab (DRUG), Lenvatinib (DRUG).

Who is sponsoring clinical trial NCT04955743?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04955743's enrollment target sits among peer trials

18 1898th of 2000 higher than 98 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 NCT04955743, the US trial registry maintained by the National Library of Medicine. NCT04955743 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.