Comparison · NCT03070392-a08c82ff
Tebentafusp vs Investigator's Choice: Safety: Number of Participants With Treatment Emergent Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Tebentafusp vs Investigator's Choice: Safety: Number of Participants With Treatment Emergent Adverse Events. Trial comparisons, record NCT03070392-a08c82ff. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03070392-a08c82ff
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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 | 1 | 0.985 | 1 | wilson | |
| Risk in group 2 | 0.946 | 0.887 | 0.975 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0541 | 0.0212 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 1.01 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Tebentafusp than on Investigator's Choice | 18.5 | 8.85 | 47.3 | from the risk difference interval |
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 | Tebentafusp | Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter. | 245 | 245 | OG000 |
| Group 2 | Investigator's Choice | 1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity. | 105 | 111 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Safety: Number of Participants With Treatment Emergent Adverse Events
- Description
- Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.
- Time frame
- Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months.
- Population
The Safety Analysis Set includes all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
- NCT number
- NCT03070392
- Phases
- PHASE2
- Conditions
- Uveal Melanoma
- Interventions
- IMCgp100, Dacarbazine, Ipilimumab, Pembrolizumab
- Lead sponsor
- Immunocore Ltd
- Results first posted
- 2021-09-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03070392?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.
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