Northwest Arkansas Clinical Trials Center has been a dedicated dermatology research center for more than 7 years. The research center is located in the heart of Northwest Arkansas, home to a regional population of more than 500,000 residents and two large college campuses. The clinical trials center has over 1500 square feet solely dedicated to dermatology research and research subjects. The center includes a reception area, examination rooms, laboratory, locked and temperature monitored investigational product ambient storage, study coordinator offices, and temperature monitored refrigerator and -20 C freezer. All equipment undergoes certification annually.

The combined clinical trial team experience in phase I-phase IV studies exceeds 50 years. Investigational product formulation experience includes oral, intravenous, topical and other parenteral routes. All personnel have certified GCP training and most are IATA certified. The staff is very familiar with the variety of electronic data capture (EDC) platforms and are very proficient in data entry.

The center and personnel have clinical trial experience in the following dermatologic conditions in pediatric, adolescent and adult populations:

  • Atopic Dermatitis
  • Alopecia
  • Hyperhidrosis
  • Psoriasis
  • Acne
  • Common Warts
  • Seborrheic Keratosis
  • Rosacea
  • Hidradenitis suppurativa
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Reviewing x-ray: FDA-approved combinations of medications can shrink melanoma tumors and stop the cancer from spreading for a longer time.

If you have advanced melanoma, this means the cancer has spread. Surgery alone cannot remove the cancer. You’ll need other treatment.

One option that your doctor may talk about is combination therapy. It involves using two or more treatments at the same time to fight the cancer. This approach helps to attack the cancer in different ways.

One type of combination therapy is helping some patients with advanced melanoma. It involves taking two of the newer treatments for advanced melanoma. Results from clinical trials show that this approach can stop the cancer from spreading for longer than ever before. The combinations are also working for more patients, so more patients with advanced melanoma are living longer.

Receiving two drugs instead of one is also giving a few more patients complete clearing of their cancer. The number of patients with no sign of cancer, however, is still small.

Because of these breakthroughs, the U.S. Food and Drug Administration (FDA) has approved 3 combinations of these newer medications to treat advanced melanoma.

To be eligible to receive some of these approved combinations, the patient must have a BRAF-gene mutation. About half the people diagnosed with melanoma have a BRAF-gene mutation.

Your doctor can test you for a BRAF-gene mutation by taking a sample from a melanoma tumor.

FDA-approved combination therapies for advanced melanoma


Trafinlar® (dabrafenib) + Mekinsit® (trametinib)  
Type of treatment Targeted therapy
Patient must have a BRAF gene mutation Yes
How many patients had their cancer stop spreading, tumors shrink, or both 70%
Average time before cancer starts to spread again 12 months
Most common side effects Fever, chills, low white blood cell count
Type of medicine Pills - Most patients take dabrafenib twice a day and trametinib once a day.
How long patient takes the medicine As long as the medicine works or side effects cause the patient to stop taking the medicine.


Zelboraf® (vermurafenib) + Cotellic® (cobimetinib)
 
Type of treatment
Targeted therapy
Patient must have a BRAF gene mutation
Yes
How many patients had their cancer stop spreading, tumors shrink, or both
70%
Average time before cancer starts to spread again
12 months
(65% of patients were alive 17 months after starting the treatment)
Most common side effects
Diarrhea, sensitive to sunlight, nausea, fever, and vomiting
Type of medicine
Pills - Most patients take cobimetinib once a day for 21 days and then stop taking it for 7 days. They take vermurafenib twice a day without taking a break.
How long patient takes the medicine
As long as the medicine works or side effects cause the patient to stop taking the medicine.


Opdivo® (nivolumab) + Yervoy® (ipilimumab)
 
Type of treatment
Immunotherapy
Patient must have a BRAF gene mutation
No
How many patients had their cancer stop spreading, tumors shrink, or both
60%
Average time before cancer starts to spread again
8 to 9 months
(Some patients are alive more than 3 years after starting the treatment)
Most common side effects
Rash, itch, headache, vomiting
Type of medicine
Infusion - Patients go to a hospital or cancer treatment center, getting the infusions through an IV. Both infusions can be given on the same day.
When patients get the infusions
Most patients get the infusions once every 3 weeks for 12 weeks. Side effects may cause the patient to stop treatment early.

Tell your doctor about all the side effects

If you and your doctor decide that one of these combinations treatments is right for you, it’s important to pay attention to side effects. If you develop any side effect, tell your doctor immediately. Some side effects can be reversed if caught early, so you won’t have to stop treatment.

It’s also important for your doctor to know about all side effects because some can be quite serious. About 30% of patients stop treatment due to side effects.

How you’ll know if the treatment works

Your doctor will examine you often. You will also have medical tests. Scans can show whether the cancer is shrinking. Blood tests will tell your doctor how your body is reacting to the treatment.

Could this be a treatment option for you?

If you want to know whether one of these FDA-approved combinations might be an option for you, ask the doctor treating you for melanoma.


Image: Thinkstock

References
Duan L, Mukherjee EM, et al. “Tailoring the treatment of melanoma: Implications for personalized medicine.” Yale J Biol Med. 2015; 88(4):389-95.

Guo C, McQuade JL, et al. “Clinical, molecular and immune analysis of dabrafenib and trametinib in metastatic melanoma patients that progressed on BRAF inhibitor monotherapy: a phase II clinical trial.” JAMA Oncol. 2016; 2(8):1056-64.

Larkin, J, Ascierto PA, et al. “Combined vemurafenib and cobimetinib in BRAF-mutated melanoma.” N Engl J Med 2014; 371:1867-76.

Patel AB and Patterson S. (2017, March). Update on cutaneous reactions to targeted and immune cancer therapy. In Patel AB (Director), “Cutaneous adverse events to immune checkpoint inhibitor therapy.” Focus session presented at the Annual Meeting of the American Academy of Dermatology, Orlando, FL.

U.S. Food and Drug Administration [news releases]:


U.S. Food and Drug Administration. “Nivolumab in combination with ipilimumab.” [approved drugs]. Lasted accessed February 15, 2017.


Contact Us

Northwest AR Clinical Trials Center, PLLC

(479) 876-8205
500 S 52nd St Rogers, AR 72758-8600