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Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Melanoma

Treatments

Biological: Vemurafenib
Drug: Ipilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01673854
CA184-240
2012-002054-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
Experimental group
Description:
Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
Treatment:
Drug: Ipilimumab
Biological: Vemurafenib

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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