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NCT02643550 · ClinicalTrials.gov registry record · Phase 1

Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 1 study, sponsored by Innate Pharma.

Completed
Registry status
Phase 1
Development phase
143
Enrollment target

NCT02643550: Completed Phase 1 study, sponsored by Innate Pharma.

NCT02643550 is a Phase 1 study that has completed, run by Innate Pharma. The registered enrollment target is 143 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02643550, a Phase 1 study, has completed, sponsored by Innate Pharma.

COMPLETED
Registry status
Phase 1
Development phase
143 participants
Enrollment target

Study Summary

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

Primary Outcome

To assess the occurrence of Drug Limited Toxicities (DLTs)

Interventions

  • BIOLOGICAL Cetuximab
  • BIOLOGICAL Monalizumab
  • BIOLOGICAL Anti-PD(L)1

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2015-12
Est. Completion 2023-03-28
Phase Phase 1
Innate Pharma

12 total trials

What the finished NCT02643550 record still lists

NCT02643550 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher).

The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.

NCT02643550 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02643550 about?

NCT02643550 is a clinical study titled "Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts exp...

What is the current status of trial NCT02643550?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2015-12. Estimated completion is 2023-03-28.

What interventions are being tested in trial NCT02643550?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Monalizumab (BIOLOGICAL), Anti-PD(L)1 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02643550?

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

How this trial's enrollment target compares

Where NCT02643550's enrollment target sits among peer trials

143 401st of 2000 higher than 1,600 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 NCT02643550, the US trial registry maintained by the National Library of Medicine. NCT02643550 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.