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NCT04704219 · ClinicalTrials.gov registry record · Phase 2

Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

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

Completed
Registry status
Phase 2
Development phase
160
Enrollment target

NCT04704219: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.

NCT04704219 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 160 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

NCT04704219, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 2
Development phase
160 participants
Enrollment target

Study Summary

This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.

Primary Outcome

ORR was defined as the percentage of participants who had a best overall response of either 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 as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR as assessed per RECIST 1.1 by blinded independent central review (BICR) is presented.

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Lenvatinib

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2021-02-23
Est. Completion 2025-10-21
Phase Phase 2
Merck Sharp & Dohme

558 total trials

What the finished NCT04704219 record still lists

NCT04704219 is an interventional study that assigns participants to a tested intervention. The registered 160 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 2 interventions - of which Pembrolizumab is the first listed.

NCT04704219 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04704219 about?

NCT04704219 is a clinical study titled "Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)". This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.

What is the current status of trial NCT04704219?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2021-02-23. Estimated completion is 2025-10-21.

What interventions are being tested in trial NCT04704219?

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

Who is sponsoring clinical trial NCT04704219?

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 NCT04704219's enrollment target sits among peer trials

160 422nd of 2000 higher than 1,559 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 NCT04704219, the US trial registry maintained by the National Library of Medicine. NCT04704219 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.