Health TrialsbyHealthPanel

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

ConditionsLung Cancer MetastaticRenal Cell CarcinomaHead and Neck CancerTriple Negative Breast CancerMerkel Cell CarcinomaHepatocellular CarcinomaMelanomaUrothelial CarcinomaColorectal Carcinoma With Microsatellite InstabilityEsophageal Squamous Cell CarcinomaEndometrial CarcinomaCervical CancerGastric/Gastro-esophageal Junction/Esophageal AdenocarcinomaBasal Cell CarcinomaSquamous Skin Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reduced dose intensity of IO

    Drug

    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

Treatment groups

646 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

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.

Time frame
From randomization to disease progression or death, up to 3 years

Secondary outcomes

1

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.

Time frame
3 years
2

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.

Time frame
From randomization to disease progression or death, up to 3 years
3

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.

Time frame
From randomization to 12 and 24 months post-randomization
4

Overall survival (OS)

The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

Time frame
From randomization to death from any cause, up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNICANCER

Lead sponsor

Source ClinicalTrials.gov
Apply now