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COMBAT 1: A Phase II Trial of Combined BRAF-Targeted Therapy and Immunotherapy for Melanoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

COMBAT 1: A Phase II Trial of Combined BRAF-Targeted Therapy and Immunotherapy for Melanoma

You will take oral vemurafenib twice a day for 2 weeks. Following this lead-in period, you
will receive aldesleukin via IV infusion on Day 15 of the study. One course of aldesleukin
is 12 weeks long; you will receive aldesleukin via IV infusion every 8 hours for the first
five days. Youi will be hospitalized for the 5 days that you are receiving aldesleukin. This
week that you are hospitalized will be referred to as Week 1. Week 1 of aldesleukin will be
days 15-19 (M-F) of the 12 week cycle. Following Week 1 of therapy, you will be discharged
from the hospital and only take vemurafenib at home for the following week. You wil then
come in for one more week of aldesleukin during days 29-33 of the 12 week cycle. This is
referred to as Week 2 of aldesleukin.

You will continue to take vemurafenib twice daily during the course of aldesleukin. Your
cancer will be evaluated at screening and at Week 12 following the beginning of the first
aldesleukin course with a CT scan. After the first cycle, your tumor will be evaluated every
8 weeks for the first year, then every 12 weeks for years 2 and 3, every 6 months for year
5, and annually thereafter.

During the research study, you will come into the clinic weekly for various tests and

If scans show that your cancer has improved after the first course of aldesleukin, your
doctor may allow you to continue on the a second course. In the event of a second course of
aldesleukin, you will remain on vemurafenib throughout the second course. If your doctor
decides you will not receive a second course of aldesleukin, you may still remain on
vemurafenib until one of the following events occurs: Your cancer becomes worse, you
experience serious side effects that are from taking vemurafenib, you request to discontinue
taking vemurafenib/withdraw from the study, you develop another illness that prevents you
from being able to take vemurafenib, the study is terminated by the sponsor or your study
doctor decides it is in your best interest to discontinue treatment with vemurafenib.

In some cases if your cancer does get worse, but you and your study doctor believe you are
still benefitting from vemurafenib in some way, you may continue receiving it after you
consult with the study director.

After the final dose of the study drug we would like to keep track of your medical condition
for the rest of your life. We would like to do this by calling you on the telephone once a
year to see how you are doing. Keeping in touch with you and checking your condition every
year helps us look at the long-term effects of the research study.

Inclusion Criteria:

- Histologically confirmed metastatic or unresectable melanoma with V600E mutation

- Measurable disease

- May have received prior immunotherapy (excluding interleukin 2)

- Life expectancy greater than 3 months

- Recovered from effects of previous surgery and/or traumatic injury

- Must agree to use effective contraception

Exclusion Criteria:

- Pregnant or breastfeeding

- Psychological, familial or other conditions that could hamper compliance with

- Receiving other study agents

- History of carcinomatous meningitis

- Known active brain metastases

- Have received a BRAF inhibitor

- Uncontrolled intercurrent illness

- HIV positive on antiretroviral therapy

- History of a different malignancy within past 5 years (except cervical cancer in situ
or basal/squamous cell carcinoma of the skin)

- Active hepatitis B or C

- Have received allogenic bone marrow transplant or organ transplant

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of Vemurafenib + Aldesleukin

Outcome Description:

To assess the efficacy (as measured by progression-free survival (PFS)) of patients with metastatic melanoma with V600E mutation treated with the combination of vemurafenib and aldesleukin in comparison to an historic control of vemurafenib alone

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Melanoma
  • Metastatic
  • Unresectable
  • V600E mutation
  • Melanoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617