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
NCT ID: NCT05078047
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
646 participants
INTERVENTIONAL
2022-03-08
2027-03-07
Brief Summary
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Detailed Description
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No major dose-dependent effect of anti-PD-1 have been observed and whether the frequency of infusion of IO could improve response or maintain efficacy. Moreover, phase I studies have shown that saturation of the target (PD-1 or PD-L1) can persist far beyond the serum half-life of the IO and 3-monthly infusions of an anti-PD-1 antibody could potentially generate the same level of activity as infusions administered every 2 weeks.
In silico modeling studies have suggested that alternate scheduling with IO couldn't compromise the efficacy of the treatment. Indeed, prolonged half-lives of IO drugs, time-varying clearance plus plasma concentrations far above the threshold associated with maximal target-engagement, suggest that the rhythm of administration of IO could be slowed down.
Without substantial international data for responding patients, apart metastatic melanoma in complete response, patients and physicians are afraid of stopping treatment, by fear of relapse. Over-treatment with IO may be toxic and inefficient. The rising cost of cancer care in the era of immunotherapy is of great concern for public and private payers around the world.
Chronic administration has important consequences for patients and health systems, with multiple medical visits and the risk of chronic, progressive and sometimes fatal toxicities induced by immunotherapy.
This is a pragmatic and strategic study challenging the routine practice which compares for the first time in a randomized phase III study, the standard administration of IO versus the same agent administered each three months in patients with metastatic cancer in partial or complete response after 6 months of standard IO ( except melanoma in CR).
If our hypothesis of non-inferiority of PFS with a reduced dose intensity of IO is verified, this could replace standard treatment and have a positive medico-economic impact, allowing, on the one hand, a reduction of the costs associated with the treatment and the toxicity, and on the other hand, an increase of the patients' quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
• Experimental arm: Reduced dose intensity of 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.
• Control arm: Standard IO
Continuation of IO at the same dose levels and rhythmicity until disease progression, unacceptable toxicity, death or patient's choice.
Random allocation will be stratified by tumour type, by response status (partial response versus complete response) evaluated 6 months after the initiation of standard IO, by treatment line (first line vs others), and by type of IO
TREATMENT
NONE
Study Groups
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Experimental arm
Reduced dose intensity of 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
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
Control arm
Standard IO:
Continuation of IO at the same dose levels and rhythmicity until disease progression, unacceptable toxicity, death or patient's choice.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Gwenaëlle GRAVIS-MESCAM, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli Calmettes, Marseille
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Elouen BOUGHALEM
Role: primary
Werner HILGERS
Role: primary
Louis FRANCOIS
Role: primary
Charlotte DOMBLIDES
Role: primary
Guillaume MARIE
Role: primary
Pierre-Emmanuel BRACHET
Role: primary
Maureen BERNADACH
Role: primary
Isabelle MONNET
Role: primary
Carolina SALDANA
Role: primary
Alice HERVIEU
Role: primary
Valentine RUSTE
Role: primary
Frank PRIOU
Role: primary
Alessandra FORESTIER
Role: primary
Sabrina FALKOWSKI
Role: primary
Denis MAILLET
Role: primary
Olivier TREDAN
Role: primary
Delphine BORCHIELLINI
Role: primary
Nadine HOUEDE
Role: primary
Hélène GAUTHIER
Role: primary
Jennifer ARRONDEAU
Role: primary
Thierry ANDRE
Role: primary
Nicolas ISAMBERT
Role: primary
Laurence CROUZET
Role: primary
Pierre-Alexandre HAUSS
Role: primary
Judith RAIMBOURG
Role: primary
Dingyu XIAO
Role: primary
Tifenn L'HARIDON
Role: primary
Philippe BARTHELEMY
Role: primary
Raffaele RATTA
Role: primary
Laurys BOUDIN
Role: primary
Iphigénie KORAKIS
Role: primary
Mathilde CANCEL
Role: primary
Yohann LORIOT
Role: primary
References
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Gravis G, Marino P, Olive D, Penault-LLorca F, Delord JP, Simon C, Lamrani-Ghaouti A, Sabatier R, Ciccolini J, Boher JM. A non-inferiority randomized phase III trial of standard immunotherapy by checkpoint inhibitors vs. reduced dose intensity in responding patients with metastatic cancer: the MOIO protocol study. BMC Cancer. 2023 May 2;23(1):393. doi: 10.1186/s12885-023-10881-8.
Other Identifiers
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UC-IMM-2101
Identifier Type: -
Identifier Source: org_study_id
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