Comparison · NCT03905135-0bd7598c
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab vs Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab: Number of Participants With a Dose-limiting Toxicity (DLT)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab vs Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab: Number of Participants With a Dose-limiting Toxicity (DLT). Trial comparisons, record NCT03905135-0bd7598c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03905135-0bd7598c
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.5 | 0.0945 | 0.905 | wilson | |
| Risk difference, group 1 minus group 2 | -0.333 | -0.761 | 0.234 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.333 | 0.0347 | 3.2 | log | |
| Odds ratio, group 1 over group 2 | 0.2 | 0.006 | 6.66 | log | |
Number needed to treat, for one fewer participant with the outcome on Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab than on Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.~Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles. | 1 | 6 | OG000 |
| Group 2 | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.~Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles. | 1 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With a Dose-limiting Toxicity (DLT)
- Description
A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) or avelumab by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
- Time frame
- First 28 days of treatment
- Population
Source ClinicalTrials.gov
Trial
- Title
- Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
- NCT number
- NCT03905135
- Phases
- PHASE1
- Conditions
- Peripheral T-cell Lymphoma NOS, Mycosis Fungoides, Sezary Syndrome, Anaplastic Large Cell Lymphoma
- Interventions
- rhIL-15, rhIL-15, Avelumab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2022-09-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03905135?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT03905135-0bd7598c