Lung Cancer MetastaticPhase 3MOIONCT05078047
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
A Phase 3 study testing Reduced dose intensity of IO in people with Lung Cancer Metastatic and Renal Cell Carcinoma, run by UNICANCER at 33 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- Reduced dose intensity of IO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 33 sitesFrance
- Study dates
- 8 Mar 2022to 7 May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
- Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study.
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
Institut de cancérologie de l'Ouest
Angers, 49055
Clinique Sainte Catherine
Avignon, 84918
Centre Hospitalier de la Côte Basque
Bayonne, 64109
CHU Bordeaux - Hôpial Saint André
Bordeaux
CH Boulogne sur Mer
Boulogne-sur-Mer
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Hospitalier Intercommunal
Créteil, 94010
CHU Henri Mondor
Créteil, 94010
Centre Georges François Leclerc
Dijon, 21079
GH Mutualiste de Grenoble
Grenoble
CHD Vendée
La Roche-sur-Yon
Centre Oscar Lambret
Lille
Clinique Chenieux
Limoges, 87000
Hospices Civils de Lyon
Lyon, 69310
Centre Léon Bérard
Lyon
Centre Antoine Lacassagne
Nice, 06189
CHU Nîmes/Institut de cancérologie du Gard
Nîmes
Hôpital Saint Louis
Paris, 75010
Hôpital Cochin APHP
Paris
Hôpital Saint Antoine APHP
Paris
CHU Poitiers
Poitiers, 86000
Centre Eugene Marquis
Rennes, 35042
CHI Elbeuf
Saint-Aubin-lès-Elbeuf
Institut de cancérologie de l'Ouest
Saint-Herblain, 44805
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô
Clinique Mutualiste de l'Estuaire
Saint-Nazaire
ICANS
Strasbourg, 67200
Hôpital Foch
Suresnes, 92151
HIA Sainte Anne
Toulon
IUCT
Toulouse, 31059
CHU Bretonneau
Tours, 37044
Centre Gustave Roussy
Villejuif
About this study
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
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.
Read the detailed description
Immunotherapy (IO) is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. For currently approved immunotherapies such as PD-1 / PD-L1 inhibitors and anti-CTLA-4, the rhythm and duration of treatment are recommended until disease progression or unacceptable toxicity. However, the optimal duration of these treatments is currently unknown.
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
- Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer, Triple Negative Breast Cancer, Merkel Cell Carcinoma, Hepatocellular Carcinoma
- Being tested
- Reduced dose intensity of IO
- Keywords
- Immunotherapy
- Medical subject headings
- Carcinoma, Renal Cell, Head and Neck Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Merkel Cell, Carcinoma, Hepatocellular, Melanoma, Carcinoma, Transitional Cell, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced dose intensity of IODrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | 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 Receives: Drug: Reduced dose intensity of IO |
| Control arm | No intervention | Standard IO: Continuation of IO at the same dose levels and rhythmicity until disease progression, unacceptable toxicity, death or patient's choice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to disease progression or death, up to 3 years
Secondary outcomes (10)
Cost-effectiveness analysis of the proposed therapeutic strategy
Incremental cost-effectiveness ratio (ICER) expressed as a cost per quality-adjusted life year (QALY) gained at 36 months.
Measured: 3 years
Immune progression-free survival (iPFS)
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 (Immune disease progression (iPD)). iPD will be determined locally by the investigator through the use of iRECIST in case of lesions identified at Baseline.
Measured: From randomization to disease progression or death, up to 3 years
Objective response rate (ORR)
Objective response rate (ORR) defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1 at 12 and 24 months post-randomization.
Measured: From randomization to 12 and 24 months post-randomization
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Measured: From randomization to death from any cause, up to 3 years
Duration of response (DoR)
Duration of response (DoR) defined as the time from randomization to first documented response until disease progression or death, whichever occurs first.
Measured: From randomization to disease progression or death, up to 3 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire
Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS).
The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels. This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 100 (Best imaginable health state) to 0 (Worst imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
Hospital anxiety and depression scale (HADS)
The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.
Measured: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
Fear of relapse questionnaire
The Fear of relapse questionnaire is a self-reported questionnaire aiming to better understand how these concerns of fear of relapse by patients manifest themselves.
The questionnaire contains 32 items rated on a five-point Likert-type scale (0 = "never", 1 = "seldom ", 2 = "sometimes", 3 = "often", and 4 = "always"). For all items, higher scores indicate more severe fear of relapse.
Measured: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
Safety profile
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: At 12 months and 3 years post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start8 Mar 2022
- Primary completion7 May 2029 (estimated)
- Study completion7 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 into two arms: • 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
- Masking
- None (open label)
- Enrolment
- 646 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenaëlle GRAVIS-MESCAM, MD, Principal investigator, Institut Paoli Calmettes, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078047
- Sponsor's protocol ID
- UC-IMM-2101
- Acronym
- MOIO
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37131154
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05078047
- Acronym / sponsor ID
- MOIO / UC-IMM-2101
- Conditions
- Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer, Triple Negative Breast Cancer, Merkel Cell Carcinoma, Hepatocellular Carcinoma
- Keywords
- Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 646 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 7 May 2029 (estimated)
- Study completion
- 7 May 2029 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immunotherapy (IO) is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. For currently approved immunotherapies such as PD-1 / PD-L1 inhibitors and anti-CTLA-4, the rhythm and duration of treatment are recommended until disease progression or unacceptable toxicity. However, the optimal duration of these treatments is currently unknown.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 into two arms: • 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
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Reduced dose intensity of IOReduced 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 intervention | –Standard IO: Continuation of IO at the same dose levels and rhythmicity until disease progression, unacceptable toxicity, death or patient's choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced dose intensity of IOAfter 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 | Drug | Experimental arm |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization to disease progression or death, up to 3 years
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.
10 secondary outcomes
Cost-effectiveness analysis of the proposed therapeutic strategy
Time frame: 3 years
Immune progression-free survival (iPFS)
Time frame: From randomization to disease progression or death, up to 3 years
Objective response rate (ORR)
Time frame: From randomization to 12 and 24 months post-randomization
Overall survival (OS)
Time frame: From randomization to death from any cause, up to 3 years
Duration of response (DoR)
Time frame: From randomization to disease progression or death, up to 3 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire
Time frame: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
Hospital anxiety and depression scale (HADS)
Time frame: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
Fear of relapse questionnaire
Time frame: At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization
Safety profile
Time frame: At 12 months and 3 years post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 37131154Gravis 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenaëlle GRAVIS-MESCAM, MD principal investigator
Institut Paoli Calmettes, Marseille
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reduced dose intensity of IO in people with Lung Cancer Metastatic and Renal Cell Carcinoma, run by UNICANCER at 33 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From randomization to disease progression or death, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05078047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.