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A phase 2 trial of Tremelimumab, Durvalumab, Bevacizumab in hepatocellular carcinoma, run by MedImmune LLC, active and no longer recruiting.
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT02519348 by MedImmune LLC, with 433 participants enrolled, started 2015-10-19 and due to reach its primary completion in 2020-11-06. Interventions recorded: Tremelimumab, Durvalumab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2021; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
433 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2021-12-06), not from a publication
Source95% CI 6.87 to 20.99; Figures from the ClinicalTrials.gov results section (first posted 2021-12-06), not from a publication · 95% CI 8.74 to 16.79 · 95% CI 10.55 to 22.83 · 95% CI 11.33 to 20.24 · 95% CI 8.38 to 14.95 · Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. · 95% CI 13.96 to NA · 95% CI 2.20 to 20.96 · 95% CI 0.66 to 23.82
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs)primary | Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 16 | 0 participants | - | - | link |
| Overall Survival (OS) | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 40 | 12.58 months | - | - | link |
| Parts 2 and 3: Durvalumab 1500 mg | 104 | 12.91 months | ||||
| Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | 75 | 17.05 months | ||||
| Parts 2 and 3: Tremelimumab 750 mg | 69 | 17.05 months | ||||
| Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | 84 | 11.3 months | ||||
| Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | 47 | Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. | ||||
| China Cohort: Durvalumab 20 mg/kg | 3 | 30.69 months | ||||
| China Cohort: Tremelimumab 10 mg/kg | 5 | 3.52 months | ||||
| China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 6 | 6.28 months |
Shares Durvalumab, Bevacizumab, Anti-angiogenic therapy, AstraZeneca.
Shares Tremelimumab, Advanced hepatocellular carcinoma (BCLC C), Bevacizumab, Anti-angiogenic therapy.
Shares Tremelimumab, Advanced hepatocellular carcinoma (BCLC C), Durvalumab, AstraZeneca.
Shares Tremelimumab, Advanced hepatocellular carcinoma (BCLC C), Durvalumab, AstraZeneca.
Shares Tremelimumab, Advanced hepatocellular carcinoma (BCLC C), Durvalumab, Anti-angiogenic therapy.
Shares Durvalumab, Bevacizumab, Anti-angiogenic therapy, AstraZeneca.
Shares Advanced hepatocellular carcinoma (BCLC C), Bevacizumab, Anti-angiogenic therapy, Monoclonal antibodies.
Shares Advanced hepatocellular carcinoma (BCLC C), Bevacizumab, Anti-angiogenic therapy, Monoclonal antibodies.