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Could a lighter immunotherapy schedule keep advanced cancers in check?

NCT ID NCT05078047

Disease control Sponsor: UNICANCER 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial is for people with advanced cancers who have already responded well to 6 months of standard immunotherapy. It compares continuing the same drugs at the usual frequency versus giving them every 3 months. The goal is to see if the reduced schedule can prevent cancer progression just as effectively while lowering side effects and treatment costs.

What this could mean

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

Active substance
immunotherapy drugs (checkpoint inhibitors) given at reduced frequency
What this could lead to
If successful, this could mean many patients with advanced cancers need fewer hospital visits for immunotherapy, reducing side effects and costs without compromising disease control.
What could go wrong
This is a large phase 3 trial, but reducing treatment frequency might allow some cancers to progress faster. Results will take years to confirm.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 646 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

May 2029

An estimate. End dates often move.

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.

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: 1. Patients must have signed a written informed consent form prior to any trial specific procedures. 2. Patient aged ≥18 years old. 3. Metastatic disease (or locally advanced disease not suitable for local treatment) of initial tumor histologically confirmed including: lung cancer, renal cell cancer, head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatellite instability \[MSI\], esophageal squamous cell carcinoma, endometrial carcinoma,cervical cancer, gastric/gastro-oesophageal junction adenocarcinoma, basal cell carcinoma or squamous skin carcinoma. 4. Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST or PERCIST v1.0 criteria (confirmed by local radiological assessment). For metastatic melanoma only patients in partial response. Patients with metastatic or advanced cancer treated by immunotherapy as maintenance therapy can be included without any lesion at IO initiation. In this case, response after 6 months of standard immunotherapy will be evaluated by the non-appearance of a new lesion. 5. Eligible to maintain the same standard IO treatment. 6. Patient with Eastern cooperative oncology group (ECOG) performance status ≤1. 7. Patients with brain metastases are allowed, provided they are stable according to the following definitions: treated with surgery or stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases. 8. Patients treated by IO previously combined with chemotherapy are allowed. 9. Patients with Tyrosine Kinase Inhibitor (TKI)-IO or pemetrexed-IO or bevacizumab-IO are allowed. 10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for pre-menopausal patients. 11. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use adequate contraception method for the duration of the study treatment and after completing treatment according to the most recent version of the IO Summary of product characteristics (SmPC). 12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up. 13. Patient must be affiliated to a Social Security System. Exclusion Criteria: 1. Metastatic melanoma in complete response. 2. Metastatic renal cell carcinoma with International Metastatic Renal Cell Carcinoma Database (IMDC) favourable-risk treated TKI/IO combination. 3. Hematologic malignancies (leukaemia, myeloma, lymphoma…) 4. Active infection requiring systemic therapy. 5. Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study. 6. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study. 7. Person deprived of their liberty or under protective custody or guardianship.

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma cervical cancer cutaneous neuroendocrine carcinoma endometrial carcinoma endometrium neoplasm esophageal squamous cell carcinoma head and neck cancer Head and Neck Neoplasms hepatocellular carcinoma lung cancer melanoma renal cell carcinoma skin squamous cell carcinoma transitional cell carcinoma triple-negative breast carcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Basal cell carcinoma Cervical cancer Colorectal carcinoma with microsatellite instability Endometrial carcinoma Esophageal squamous cell carcinoma Gastric/gastro-esophageal junction/esophageal adenocarcinoma Head and neck cancer Hepatocellular carcinoma Lung cancer metastatic Melanoma Merkel cell carcinoma Renal cell carcinoma Squamous skin carcinoma Triple negative breast cancer Urothelial carcinoma

Contacts and locations

Locations

  • CH Boulogne sur Mer

    Boulogne-sur-Mer, France

  • CHD Vendée

    La Roche-sur-Yon, France

  • CHI Elbeuf

    Saint-Aubin-lès-Elbeuf, France

  • CHU Bordeaux - Hôpial Saint André

    Bordeaux, France

  • CHU Bretonneau

    Tours, 37044, France

  • CHU Henri Mondor

    Créteil, 94010, France

  • CHU Nîmes/Institut de cancérologie du Gard

    Nîmes, France

  • CHU Poitiers

    Poitiers, 86000, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Gustave Roussy

    Villejuif, France

  • Centre Hospitalier Intercommunal

    Créteil, 94010, France

  • Centre Hospitalier Mémorial de Saint-Lô

    Saint-Lô, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63000, France

  • Centre Léon Bérard

    Lyon, France

  • Centre Oscar Lambret

    Lille, France

  • Clinique Chenieux

    Limoges, 87000, France

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, France

  • Clinique Sainte Catherine

    Avignon, 84918, France

  • GH Mutualiste de Grenoble

    Grenoble, France

  • HIA Sainte Anne

    Toulon, France

  • Hospices Civils de Lyon

    Lyon, 69310, France

  • Hôpital Cochin APHP

    Paris, France

  • Hôpital Foch

    Suresnes, 92151, France

  • Hôpital Saint Antoine APHP

    Paris, France

  • Hôpital Saint Louis

    Paris, 75010, France

  • ICANS

    Strasbourg, 67200, France

  • IUCT

    Toulouse, 31059, France

  • Institut de cancérologie de l'Ouest

    Angers, 49055, France

  • Institut de cancérologie de l'Ouest

    Saint-Herblain, 44805, France

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