RecruitingPhase 3NCT05078047

Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO

Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO


Sponsor

UNICANCER

Enrollment

646 participants

Start Date

Mar 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving immunotherapy (checkpoint inhibitors) every 3 months instead of the standard schedule — for patients whose cancer responded well after 6 months of standard treatment — is just as effective but with fewer side effects and clinic visits. **You may be eligible if...** - You are 18 or older - You have metastatic or locally advanced cancer (lung, kidney, head and neck, bladder, breast, melanoma, liver, colorectal with MSI, and others) that responded fully or partially to at least 6 months of standard immunotherapy - You are eligible to continue the same immunotherapy - Your general health is good (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is still actively progressing - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have severe autoimmune disease or organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGReduced dose intensity of IO

After 6 months of treatment with standard IO, IO will be administered every 3 months (at the same dose levels) until disease progression, unacceptable toxicity, death or patient's choice or investigator's decision


Locations(40)

Institut de cancérologie de l'Ouest

Angers, France

Clinique Sainte Catherine

Avignon, France

Centre Hospitalier de la Côte Basque

Bayonne, France

CHU Besançon

Besançon, France

CHU Bordeaux - Hôpial Saint André

Bordeaux, France

CH Boulogne sur Mer

Boulogne-sur-Mer, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Hospitalier Intercommunal

Créteil, France

CHU Henri Mondor

Créteil, France

Centre Georges François Leclerc

Dijon, France

GH Mutualiste de Grenoble

Grenoble, France

CHD Vendée

La Roche-sur-Yon, France

Centre Oscar Lambret

Lille, France

Clinique Chenieux

Limoges, France

Hospices Civils de Lyon

Lyon, France

Centre Léon Bérard

Lyon, France

Hôpital La Timone -APHM

Marseille, France

Centre Antoine Lacassagne

Nice, France

CHU Nîmes/Institut de cancérologie du Gard

Nîmes, France

Institut Curie

Paris, France

Hôpital Saint Louis

Paris, France

Hôpital Pitié Salpêtrière

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital Cochin APHP

Paris, France

Hôpital Saint Antoine APHP

Paris, France

CHU Poitiers

Poitiers, France

Insitut Godinot

Reims, France

Centre Eugene Marquis

Rennes, France

CHI Elbeuf

Saint-Aubin-lès-Elbeuf, France

Institut Curie

Saint-Cloud, France

Institut de cancérologie de l'Ouest

Saint-Herblain, France

Centre Hospitalier Mémorial de Saint-Lô

Saint-Lô, France

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

ICANS

Strasbourg, France

Hôpital Foch

Suresnes, France

HIA Sainte Anne

Toulon, France

IUCT

Toulouse, France

CHU Bretonneau

Tours, France

Centre Gustave Roussy

Villejuif, France

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NCT05078047


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