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
MOIO
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
1 other identifier
interventional
646
1 country
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2022
Longer than P75 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedStudy Start
First participant enrolled
March 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 7, 2027
June 5, 2025
May 1, 2025
5 years
September 30, 2021
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
From randomization to disease progression or death, up to 3 years
Secondary Outcomes (10)
Cost-effectiveness analysis of the proposed therapeutic strategy
3 years
Immune progression-free survival (iPFS)
From randomization to disease progression or death, up to 3 years
Objective response rate (ORR)
From randomization to 12 and 24 months post-randomization
Overall survival (OS)
From randomization to death from any cause, up to 3 years
Duration of response (DoR)
From randomization to disease progression or death, up to 3 years
- +5 more secondary outcomes
Study Arms (2)
Experimental arm
EXPERIMENTALReduced 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
NO INTERVENTIONStandard IO: Continuation of IO at the same dose levels and rhythmicity until disease progression, unacceptable toxicity, death or patient's choice.
Interventions
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
You may qualify if:
- Patients must have signed a written informed consent form prior to any trial specific procedures.
- Patient aged ≥18 years old.
- 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.
- 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.
- Eligible to maintain the same standard IO treatment.
- Patient with Eastern cooperative oncology group (ECOG) performance status ≤1.
- 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.
- Patients treated by IO previously combined with chemotherapy are allowed.
- Patients with Tyrosine Kinase Inhibitor (TKI)-IO or pemetrexed-IO or bevacizumab-IO are allowed.
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for pre-menopausal patients.
- 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).
- 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.
- Patient must be affiliated to a Social Security System.
You may not qualify if:
- Metastatic melanoma in complete response.
- Metastatic renal cell carcinoma with International Metastatic Renal Cell Carcinoma Database (IMDC) favourable-risk treated TKI/IO combination.
- Hematologic malignancies (leukaemia, myeloma, lymphoma…)
- Active infection requiring systemic therapy.
- 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.
- Person deprived of their liberty or under protective custody or guardianship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (40)
Institut de cancérologie de l'Ouest
Angers, 49055, France
Clinique Sainte Catherine
Avignon, 84918, France
Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
CHU Besançon
Besançon, 25030, France
CHU Bordeaux - Hôpial Saint André
Bordeaux, France
CH Boulogne sur Mer
Boulogne-sur-Mer, France
Centre François Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Hospitalier Intercommunal
Créteil, 94010, France
CHU Henri Mondor
Créteil, 94010, France
Centre Georges François Leclerc
Dijon, 21079, France
GH Mutualiste de Grenoble
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
Centre Oscar Lambret
Lille, France
Clinique Chenieux
Limoges, 87000, France
Hospices Civils de Lyon
Lyon, 69310, France
Centre Léon Bérard
Lyon, France
Hôpital La Timone -APHM
Marseille, 13385, France
Centre Antoine Lacassagne
Nice, 06189, France
CHU Nîmes/Institut de cancérologie du Gard
Nîmes, France
Institut Curie
Paris, 75005, France
Hôpital Saint Louis
Paris, 75010, France
Hôpital Pitié Salpêtrière
Paris, 75013, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Hôpital Cochin APHP
Paris, France
Hôpital Saint Antoine APHP
Paris, France
CHU Poitiers
Poitiers, 86000, France
Insitut Godinot
Reims, 51726, France
Centre Eugene Marquis
Rennes, 35042, France
CHI Elbeuf
Saint-Aubin-lès-Elbeuf, France
Institut Curie
Saint-Cloud, 92210, France
Institut de cancérologie de l'Ouest
Saint-Herblain, 44805, France
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
ICANS
Strasbourg, 67200, France
Hôpital Foch
Suresnes, 92151, France
HIA Sainte Anne
Toulon, France
IUCT
Toulouse, 31059, France
CHU Bretonneau
Tours, 37044, France
Centre Gustave Roussy
Villejuif, France
Related Publications (1)
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.
PMID: 37131154DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gwenaëlle GRAVIS-MESCAM, MD
Institut Paoli Calmettes, Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 14, 2021
Study Start
March 8, 2022
Primary Completion (Estimated)
March 7, 2027
Study Completion (Estimated)
March 7, 2027
Last Updated
June 5, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
- Access Criteria
- Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.