Neoadjuvant PD-1 Blockade in Patients With Stage IIB/C Melanoma

  • STATUS
    Recruiting
  • End date
    Feb 8, 2026
  • participants needed
    63
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 8 June 2022
serum pregnancy test
anticoagulants
direct bilirubin
anticoagulant therapy
pembrolizumab
thromboplastin
immunomodulators
immunologic adjuvant
mucosal melanoma

Summary

The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma.

Subjects with stage II melanoma will receive one dose of pembrolizumab 200 mg, then undergo standard definitive surgery with wide excision and sentinel lymph node (SLN) biopsy approximately 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.

Details
Condition Melanoma
Treatment Pembrolizumab, Wide Excision and Sentinel Lymph Node (SLN) Biopsy
Clinical Study IdentifierNCT03757689
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject must have clinical stage IIB or IIC resectable MEL. Subjects may not have a diagnosis of uveal or mucosal melanoma
Either the subject or the subject's legal representative must be willing and able to provide written informed consent for the trial
The subject must be ≥18 years of age on day of signing informed consent
The subject must have a performance status of 0 or 1 on the ECOG Performance Scale
The subject must demonstrate adequate organ function as defined in Table 1; all screening labs must be performed within 21 days of treatment initiation
System Laboratory Value
Hematologic
ANC ≥1500/mcL
Platelets ≥100,000/mcL
Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal
Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR
≥50 mL/min for subject with creatinine levels >1.5 X institutional ULN
Hepatic
Serum total bilirubin ≤1.5 X ULN OR
Direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN
AST (SGOT) and ALT (SPGT) ≤2.5 X ULN OR ≤5 X ULN for subjects with liver metastases
Coagulation
International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Female participants
A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions
applies
Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and must be willing to use 2 methods of contraception or abstain from heterosexual intercourse for at least 2 weeks prior to the time of first dose of study medication through 120 days after the last dose of study medication
Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Female subjects of childbearing potential are defined as those women who have not been surgically sterilized or have not been free from menses for >1 year
Male participants
Male subjects must agree to follow the contraceptive guidance in Appendix 3 starting with the first dose of study medication, while on study, through 120 days after the last dose of study medication

Exclusion Criteria

Subject has unresectable disease; i.e. in the opinion of the surgical oncologist, all of the subject's melanoma cannot be completely removed with a clear margin
A woman of child bearing potential who has a positive urine pregnancy test within 72 hours prior to first dose of study drug (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Note: In the event that 72 hours have elapsed between the screening pregnancy test and the
first dose of study treatment, another pregnancy test (urine or serum) must be performed
and must be negative in order for subject to start receiving study medication
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 (e.g
CTLA-4, OX 40, CD137), interferon, high dose IL-2 or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways
Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks Note: Participants must have recovered from all AEs due to previous
therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy are an
exception to this criterion
If participant received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting study treatment
Subject has received transfusion of blood products (including platelets or red blood
cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or
Has an active infection requiring systemic therapy
recombinant erythropoietin) within 4 weeks prior to study Day 1
Has received a live vaccine within 30 days prior to the first dose of study drug
Examples of live vaccines include, but are not limited to, the following: measles
Has a known history of active TB (Bacillus Tuberculosis)
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
are generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed
Is currently participating in or has participated in a study of an investigational
Has hepatic decompensation (Child-Pugh score >6 [class B and C])
agent or has used an investigational device within 4 weeks prior to the first dose of
Has uncontrolled thyroid dysfunction
study treatment
Has uncontrolled diabetes mellitus
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug
Has a known additional malignancy that is progressing or requires active treatment
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of
the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that
have undergone potentially curative therapy are not excluded
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has active autoimmune disease that has required systemic treatment in the past 3
months (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency
etc.) is not considered a form of systemic treatment
Has evidence of active interstitial lung disease or a history of (non-infectious)
pneumonitis that required steroids or has current pneumonitis
Has a known history of Human Immunodeficiency Virus (HIV). (HIV 1/2 antibodies) as
determined by medical record review
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection
as determined by medical record review
Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of trial treatment
Has severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment
congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease
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