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8110 Gatehouse Road, Falls Church, VA 22042

KEYNOTE 716: Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03553836

Background Information

The purpose of this study is to: test the safety of the research study drug, Pembrolizumab (MK-3475), also known as KEYTRUDA® and see how well the study drug, pembrolizumab, works compared to placebo in keeping cancer from coming back or spreading.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Male/female participants with surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma.
  • Participants must have T stage of T3b, T4a, or T4b (Table 3) with pathologically confirmed negative sentinel lymph node biopsy, and no evidence of regional (N0) or distant metastatic disease (M0).
  • Additional eligibility in protocol.

Ineligibility Information

  • Participants may not have been treated with radiation therapy for their melanoma prior to study entry.
  • Participants must not have been previously treated for melanoma beyond complete surgical resection of the current primary melanoma lesion.
  • If Participant has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) or surgery treatment within the past 5 years.
  • Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received prior systemic anti-cancer therapy for melanoma including investigational agents.
  • Additional ineligibility in protocol.

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03553836