At a glance
ClinicalIndex Comparison Record- ✓Aged ≥18 years old
- ✓Metastatic or locally advanced disease not suitable for local treatment, histologically confirmed
- ✓Partial or complete response after 6 months of standard immunotherapy per RECIST or PERCIST v1.0
- ✓For metastatic melanoma: partial response only
- ✕Metastatic melanoma in complete response
- ✕Metastatic renal cell carcinoma with IMDC favourable-risk treated with TKI/IO combination
- ✕Hematologic malignancies (leukemia, myeloma, lymphoma)
- ✕Active infection requiring systemic therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Reduced dose intensity of IO for Lung Cancer Metastatic and 14 related conditions. Currently recruiting, targeting 646 participants across 40 sites.
Signals
Detailed 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.
Study Details
Timeline
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