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A Phase II Randomized Study of Adjuvant versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma

Status
Active
Cancer Type
Melanoma
Skin Cancer (Non-Melanoma)
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03698019
Protocol IDs
S1801 (primary)
S1801
NCI-2018-02107
Study Sponsor
SWOG

Summary

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better in treating melanoma.

Objectives

PRIMARY OBJECTIVES:
I. To compare event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant MK-3475 (pembrolizumab) with patients randomized to adjuvant MK-3475 (pembrolizumab).

SECONDARY OBJECTIVES:
I. To assess the frequency and severity of toxicities on each of the arms.
II. To compare between arms overall survival (OS), disease control at 24 weeks, locoregional control in the surgical site(s), and total number of MK-3475 (pembrolizumab) doses received.
III. On the neoadjuvant arm, to estimate the pathologic response rate, the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response rate (confirmed complete response [CR] and partial response [PR]), and the immune-related (i)RECIST response rate (confirmed CR and PR), before surgical resection; to compare definitions of pathologic partial response; and to evaluate the association between pathologic response and EFS and OS.
IV. To describe the proportion of patients on each arm who received the surgery planned at randomization.

ADDITIONAL OBJECTIVES:
I. To bank tumor tissue and whole blood in anticipation of future correlative studies in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Within 84 days after surgical resection, patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 courses, then undergo surgical resection within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 12 weeks, then every 3, 6, or 12 months for up to 10 years.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofitthat leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.