Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone
Status: | Completed |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/12/2018 |
Start Date: | December 20, 2013 |
End Date: | April 24, 2018 |
A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects With Metastatic or Unresectable Melanoma in Combination With Dabrafenib and Trametinib or With Trametinib Alone
The purpose of this study is to determine the maximum tolerated dose and the safety profile
of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in
subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type
BRAF, respectively.
of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in
subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type
BRAF, respectively.
Inclusion Criteria:
- Adults >/= 18 years old
- Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable)
or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive
(cohort A) or mutation-negative (cohorts B and C)
- ECOG performance status of 0 or 1
- Measurable disease by radiographic or physical examination
- Adequate organ and marrow function
- Willingness to provide consent for biopsies positive or BRAF WT measurable disease,
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate
organ and marrow function
Exclusion Criteria:
- Prior treatment with a BRAF inhibitor or MEK inhibitor
- Any prior Grade ≥ 3 immune-related adverse event while receiving immunotherapy
- Active or prior documented autoimmune disease within the past 2 years
- History of or current risk for retinal vein occlusion (RVO) or central serous
retinopathy (CSR)
- History of or current cardiovascular risk including myocardial infarction, ≥ Class II
congestive heart failure, uncontrolled arrhythmias, or refractory hypertension
- Active, untreated CNS metastases
- Women who are pregnant or lactating
We found this trial at
8
sites
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