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Clinical trials endnote free trial
Clinical trials endnote free trial












clinical trials endnote free trial

In Part 4, participants will receive durvalumab 1120 mg (15 mg/kg) + bevacizumab 15 mg/kg every 3 weeks (Q3W).

clinical trials endnote free trial

Participants will be randomized at a ratio of 2:1:2 in 'Durvalumab 1500 mg Q4W', 'Tremelimumab 750 mg Q4W for 7 doses followed by Q12W', and 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W' arms, respectively. Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W, followed by durvalumab 1500 mg Q4W.įollowing protocol amendment 5, enrollment into 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg' arm will close.Tremelimumab 750 mg Q4W for 7 doses followed by Q12W.Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W.In Part 3, participants will be randomized in a 2:2:1:2 ratio to receive: In Part 2B, participants will receive tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W.In China cohort, Part 2A study design will be followed.Tremelimumab 1 mg/kg Q4W × 4 doses + durvalumab 20 mg/kg Q4W, followed by durvalumab 20 mg/kg Q4W.Tremelimumab 10 mg/kg Q4W × 7 doses followed by every 12 weeks (Q12W).

clinical trials endnote free trial

In Part 2A, participants will be randomized in a 1:1:1 ratio to receive:

  • In Part 1 (both 1A and 1B), participants will receive tremelimumab 1 mg/kg intravenous (IV) every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W.
  • In addition, a separate cohort of participants will be enrolled in mainland China (China cohort) once global recruitment in Part 2A will be closed. Part 1A Stage 2 of the study may start after the first 3 participants in Stage 1 have been observed on study for at least 4 weeks. Participants in Part 1A (safety run-in cohort), Part 1B (efficacy-gating cohort), Part 2A, and Part 4 will receive weight-based dosing regimens and participants in Part 2B and Part 3 will receive fixed dosing regimens.
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  • Clinical trials endnote free trial