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40,000 patients studied: does a simpler cancer drug dose work just as well?

NCT ID NCT05380336

Knowledge-focused Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at 40,000 people with metastatic cancer who received the drug nivolumab. Researchers compared the old way of dosing (based on body weight) with a newer, simpler fixed dose. They used national health data to see if the fixed dose was just as good and more cost-effective over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab
What this could lead to
If successful, this study could show that a simpler fixed-dose regimen is just as effective and more cost-efficient than weight-based dosing for metastatic cancer patients.
What could go wrong
This is an observational study using existing health data, not a controlled trial. Results may be influenced by differences between patient groups, and the one-year follow-up may not capture long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40,000 people

The number who actually took part.

Started

Jan 2014

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study includes patients with metastatic cancers treated with nivolumab: lung cancer, melanoma and kidney cancer.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with metastatic melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma treated with nivolumab monotherapy * Patients whose nivolumab treatment was initiated between 2015 and 2020 * Patients with health insurance Exclusion Criteria: * Patients whose nivolumab treatment initiated in 2017 in mg/kg has progressed to a fixed dose in the 1st year of treatment * Patients treated with nivolumab in the adjuvant setting for melanoma with lymph node involvement or metastatic disease and who have undergone complete resection (Approval in 2018 for this indication) * Patients whose nivolumab treatment has been initiated in 2018

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Conditions

The condition(s) this trial relates to.

kidney cancer melanoma metastatic malignant neoplasm metastatic melanoma Neoplasm Metastasis non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic cancer

Contacts and locations

Locations

  • CHU de Nantes

    Nantes, 44093, France

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