Phase 2
Completed N=46
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
Source: ClinicalTrials.gov NCT01673854 ↗Enrolled (actual)
46
Serious AEs
73.9%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs) — 32.6 Percentage of participants
Summary
The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs) |
32.6 | — |
| SECONDARY Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs) |
21.7 | — |
| SECONDARY Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Hepatobiliary Adverse Events |
4.3 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria
- Men and women 18 years of age and older
- Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation
- Previously untreated unresectable Stage III or Stage IV melanoma
- Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28 days of first dose of study drug
- Measurable melanoma by physical or radiographic examination
- Brain metastases stable after radiation for at least 1 month and off corticosteroid therapy for ≥30 days prior to enrollment
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate hematologic parameters and renal and hepatic function
Key Exclusion Criteria
- Primary ocular melanoma
- Active brain metastases with symptoms or requiring corticosteroid treatment
- Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies
- History of or current immunodeficiency disease, splenectomy, or splenic irradiation
- Prior anticancer therapy or investigational products <4 weeks prior to enrollment
- Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer immunotherapies;
- Prior therapies with immunosuppressive agents within the past 2 years
- Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery, radiotherapy, other investigational anticancer therapies, or chronic use of systemic corticosteroids
Data sourced from ClinicalTrials.gov (NCT01673854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.