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Comparing different schedules of immunotherapy for metastatic cancers

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

PHASE3 · UNICANCER · NCT05078047

This study is testing if giving immunotherapy for metastatic cancers every three months instead of every two weeks can still help patients while being easier on their bodies and wallets.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment646 (estimated)
Ages18 Years and up
SexAll
SponsorUNICANCER (other)
Drugs / interventionsbevacizumab, chemotherapy, immunotherapy
Locations40 sites (Angers and 39 other locations)
Trial IDNCT05078047 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of administering immunotherapy (IO) every three months compared to the standard bi-weekly schedule in patients with metastatic cancers who have shown a response after six months of standard treatment. The hypothesis is that a reduced dose intensity could maintain efficacy while minimizing toxicity and costs. By utilizing in silico modeling and existing data, the study aims to determine if less frequent dosing can achieve similar outcomes in disease progression prevention. The ultimate goal is to enhance patient quality of life while addressing the economic burden of cancer care.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with metastatic cancers who have achieved a partial or complete response after six months of standard immunotherapy.

Not a fit: Patients who have not responded to standard immunotherapy or those with early-stage cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced treatment costs and improved quality of life for patients undergoing immunotherapy.

How similar studies have performed: While similar approaches have been explored, this specific scheduling of immunotherapy has not been extensively tested, making it a novel investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients must have signed a written informed consent form prior to any trial specific procedures.
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:

1. Metastatic melanoma in complete response.
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.

Where this trial is running

Angers and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer, Triple Negative Breast Cancer, Merkel Cell Carcinoma, Hepatocellular Carcinoma, Melanoma, Urothelial Carcinoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.