Study on Using Pembrolizumab Before Surgery for Stage IIB/C Melanoma

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0

ClinicalTrials ID:NCT03757689

Provider View

This clinical trial is testing whether the drug pembrolizumab, given before surgery, can reduce the spread of melanoma to nearby lymph nodes in patients with Stage IIB/C melanoma. Participants will receive pembrolizumab before surgery and continue treatment for up to a year after surgery.

Patient Parameters

Program Overview

The main goal of this study is to see if pembrolizumab, a medication given before surgery, can lower the chances of melanoma spreading to nearby lymph nodes in patients with Stage IIB/C melanoma. Participants will receive one dose of pembrolizumab, then have surgery to remove the melanoma about three weeks later. After surgery, they will continue to receive pembrolizumab every three weeks for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Must have Stage IIB or IIC melanoma that can be surgically removed.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ function based on specific blood tests.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Melanoma that cannot be completely removed by surgery.
  • Women who are pregnant or breastfeeding.
  • Previous treatment with pembrolizumab or similar drugs.
  • Recent participation in another clinical trial or use of investigational drugs.
  • Active infections or immune system disorders.
  • History of other cancers that require treatment.
  • Severe allergies to pembrolizumab.
  • Uncontrolled health conditions that could interfere with the study.
  • Known history of HIV, Hepatitis B, Hepatitis C, or active tuberculosis.
  • Severe heart disease or liver problems.
  • Uncontrolled thyroid or diabetes issues.

Locations

FACILITYZIPCITYSTATE
University of Louisville40202LouisvilleKentucky
Abramson Cancer Center of the University of Pennsylvania19104PhiladelphiaPennsylvania
The University of Texas MD Anderson Cancer Center77030HoustonTexas

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