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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
Sponsor: UNICANCER
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
646
Start Date
2022-03-08
Completion Date
2027-03-07
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
Reduced 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