Trials Under Way for Patients with Melanoma

May 2015, Vol 5, No 4 - Clinical Trials Tracker


The following clinical trials are currently recruiting patients with melanoma for inclusion in several investigations. Each trial description includes the NLM Identifier to use as a reference with ClinicalTrials.gov.

1. Immunotherapy for Patients with Stage IV Melanoma

This phase 2, randomized, open-label study aims to evaluate whether ipilimumab with or without HyperAcute-Melanoma immunotherapy can stop or slow the growth of tumors, or destroy tumors in patients with stage IV melanoma. Patients aged ≥18 years may enroll if they have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1, and if they meet other enrollment criteria. Patients will receive a 3-mg/kg injection of ipilimumab every 3 weeks for 4 treatment cycles, with or without HyperAcute-Melanoma immunotherapy at 300 million cells per scheduled immunization.

Primary outcomes, measured over a time frame of 2 years, are the safety of administration of this combination therapy, and the clinical response rate of patients with metastatic melanoma after treatment. Secondary outcome measures include clinical activity, antitumor immune response, immune activation, and antitumor mechanism. This study is expected to enroll 100 patients in Iowa City, IA; Winston-Salem, NC; and Knoxville, TN. For more information, contact Melanie Frees, RN, BSN, CCRC, at 319-356-1228 or melanie-frees@uiowa.edu; Stacey Lewis, RN, at 336-713-6927 or stalewis@wakehealth.edu; or Shanna Overbey at 865-305-5281 or soverbey@utmck.edu, respectively. The NLM Identifier is NCT02054520.

2. Talimogene Laherparepvec plus Surgery versus Surgery Alone

This phase 2, randomized, open-label study aims to estimate the efficacy of surgery after talimogene laherparepvec as a neoadjuvant treatment compared with surgery alone in patients with completely resectable stage IIIB, IIIC, or IVM1a melanoma. Patients aged ?18 years with a histologically confirmed diagnosis of stage IIIB, IIIC, or IVM1a melanoma eligible for complete surgical resection may enroll if other criteria are met. Patients will either undergo immediate surgical resection of melanoma tumor lesions, or receive intralesional injections of talimogene laherparepvec followed by surgical resection of melanoma tumor lesions.

The primary outcome measure is the efficacy of neoadjuvant talimogene laherparepvec plus surgery versus surgery alone on recurrence-free survival at 24 months after the randomization of the last study patient. Secondary outcome measures include efficacy at 3 and 5 years after the end of randomization, as well as overall response and safety. This study is expected to enroll 150 patients in Louisville, KY; Daytona Beach, FL; and Salt Lake City, UT. For more information, contact the Amgen Call Center at 866-572-6436. The NLM Identifier is NCT02211131.

3. Dabrafenib plus Trametinib for Stage IV Melanoma

This randomized, parallel­-assignment, open-label study aims to compare the safety and efficacy of receiving dabrafenib–trametinib combination therapy before surgery to surgery plus standard care in patients with clinical stage III or oligometastatic stage IV melanoma. Patients aged ?18 years with histologically or cytologically confirmed stage IIIB/C or stage IV oligometastatic melanoma and an ECOG performance status of ?1 may enroll if other criteria are met. Patients will receive surgery plus standard care, or dabrafenib–trametinib combination therapy plus surgery. Patients receiving the study drugs will continue to take them for ?44 weeks after they recover from surgery.

The primary outcome measure is the relapse-free survival rate at 1 year, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. This study is expected to enroll 84 patients at the University of Texas MD Anderson Cancer Center in Houston. For more information, contact Jennifer Wargo, MD, at 713-745-1553. The NLM Identifier is NCT02231775.

4. Dasatinib for Mucosal, Acral, or Vulvovaginal Melanomas

This phase 2, open-label, multicenter study seeks to examine the effectiveness of dasatinib in treating patients with locally advanced or metastatic mucosal, acral, or vulvovaginal melanoma. Patients aged ?18 years with acral melanoma (defined as melanoma occurring on the palms, soles, or subungual sites), melanoma occurring on the vulva/vagina, or melanoma arising on other mucosal surfaces may be eligible to enroll if other criteria are met. Patients will receive oral dasatinib twice daily on days 1 to 21, and the course will be repeated every 21 days in the absence of unacceptable toxicity or disease progression.

The primary outcome measure is the objective tumor response rate. Secondary outcome measures are response duration, progression-free survival, and the safety profile of the drug. This study is expected to enroll 87 patients at multiple locations across the United States. For more information, contact the Clinical Trials Office of Massachusetts General Hospital at 877-726-5130. The NLM Identifier is NCT00700882.

5. LGX818 plus MEK162 versus Vemurafenib and LGX818 Monotherapies

This is a phase 3, randomized, open-label study comparing the efficacy and safety of LGX818–MEK162 combination therapy with vemurafenib and LGX818 monotherapies in patients with locally advanced, unresectable, or metastatic BRAF-mutated melanoma.

Patients aged ?18 years with the presence of a BRAF V600E or V600K mutation in tumor tissue, an ECOG performance status of ?1, and evidence of ?1 measurable lesion (detected by radiologic or photographic methods) may enroll if other criteria are met.

In part 1 of the study, patients are randomized in a 1:1:1 ratio to 1 of 3 treatment arms: (1) 450 mg of LGX818 once daily plus 45 mg of MEK162 twice daily; (2) 300 mg of LGX818 once daily; or (3) 960 mg of vemurafenib twice daily. In part 2, patients are randomized in a 3:1 ratio to 1 of 2 treatment arms: (1) 300 mg of LGX818 once daily plus 45 mg of MEK162 twice daily or (2) 300 mg of LGX818 once daily. The primary outcome measure is progression-free survival, defined as the time from the date of randomization to the first date of documented disease progression or death attributed to any cause. Secondary outcome measures include overall survival, safety and tolerability of combination therapy and LGX818 monotherapy, the pharmacokinetics of LGX818 and MEK162, and objective response rates.

This study is expected to enroll 900 patients at multiple locations throughout the United States and internationally. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT01909453.

6. Pembrolizumab plus Pegylated Interferon Alfa-2b or Ipilimumab

This randomized, open-label, parallel-assignment study examines the safety, tolerability, and efficacy of combination regimens of pembroliz­umab plus pegylated interferon alfa-2b (PegIFN2b) and pembrolizu­mab plus ipilimumab for the treatment of advanced melanoma and renal-cell carcinoma. Patients aged ?18 years with an ECOG performance status of ?1, adequate organ function, and no additional malignancies that are progressing or require active treatment (except for basal-cell carcinoma or squamous- cell carcinoma of the skin, or in situ cervical cancer that has experienced potentially curative therapy) may enroll if other criteria are met.

Patients will be randomized to receive pembrolizumab plus PegIFN2b, pembrolizumab plus ipilimumab, or pembrolizumab alone. Primary outcome measures are progression-free survival as well as the number of patients with dose-limiting toxicities, experiencing adverse events, and discontinuing the study drug because of adverse events. Secondary outcome measures include objective response rate and overall survival. This study is expected to enroll 343 patients at locations in California, Massachusetts, Texas, Washington, and Washington, DC. For more information, contact Merck at 888-577-8839. The NLM Identifier is NCT02089685.

7. High-Dose Interleukin-2 plus Ipilimumab

This open-label, randomized, multicenter study compares the sequence of high-dose interleukin-2 and ipilimumab in patients with metastatic melanoma who are treatment-naïve or who have previously received a single, nonimmunologic therapy. Patients aged ≥18 years with confirmed, measurable metastatic melanoma with ≥1 measurable lesion for evaluation of response, and who have not had adjuvant therapy or any other cancer treatments for ≥4 weeks may enroll if other criteria are met.

Patients will receive either 2 courses of high-dose interleukin-2 followed by 1 course of ipilimumab, or 1 course of ipilimumab followed by 2 courses of high-dose interleukin-2. The primary outcome measure is overall survival at 1 year. This study is expected to enroll 100 patients at multiple locations across the United States. For more information, contact Theresa Luna at 858-882-8058 or tluna@prometheus@labs.com. The NLM Identifier is NCT01856023.

8. Nivolumab Monotherapy versus Combination Therapy

This phase 1, randomized, open-label study seeks to assess the biologic effects of nivolumab monotherapy versus nivolumab in combination with ipilimumab in patients with advanced unresectable or metastatic melanoma. Patients aged ≥16 years with unresectable stage III or IV melanoma who are refractory to, intolerant of, or have refused standard therapy, and who have an ECOG performance status of ≤1 may enroll if other criteria are met.

Patients will be separated into single-arm or parallel-group cohorts. Primary outcomes are the immunomodulatory effects of nivolumab monotherapy and nivolumab–ipilimumab combination therapies, measured from day 1 through day 57. Secondary outcomes include safety and tolerability of nivolumab, ipilimumab, and nivolumab in combination with ipilimumab, as measured by laboratory test abnormalities, and the incidence of adverse events, serious adverse events, death, and changes in vital signs. Objective response rates, durations of response, and progression-free survival will also be measured to determine antitumor activity. This study is expected to enroll 160 patients at multiple locations throughout the United States. For more information, contact Bristol-Myers Squibb at clinical.trials@bms.com. The NLM Identifier is NCT01621490.

9. Trametinib for Patients with Uveal Melanoma

This phase 2, randomized, open-label study will examine the efficacy of trametinib with or without GSK2141795 (a protein kinase B inhibitor) in treating patients with metastatic uveal melanoma. Patients aged ≥18 years with a life expectancy of >3 months, an ECOG performance status of ≤1, and no history of interstitial lung disease or pneumonitis may enroll if other criteria are met.

On days 1 to 28, patients in the first arm of the study will receive oral trametinib daily, and patients in the second arm will receive oral trametinib and oral GSK2141795 daily. Courses are repeated every 4 weeks for both treatment arms in the absence of toxicity or disease progression. Patients in the first treatment arm who experience objective disease progression may cross over to the second treatment arm. The primary outcome is time to progression, measured from the date of randomization to death or the date of documented progression according to RECIST criteria. Secondary outcome measures include incidence of toxicity and response rate and overall survival per RECIST criteria.

This study is expected to enroll 80 patients at multiple locations throughout the United States and internationally. For more information, contact Paul B. Chapman, MD, at 646-888-4162 or chapmanp@mskcc.org. The NLM Identifier is NCT01979523.