Neoadjuvant PD-1 Blockade in Patients With Stage IIB/C Melanoma
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|ClinicalTrials.gov Identifier: NCT03757689|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : July 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Pembrolizumab Procedure: Wide Excision and Sentinel Lymph Node (SLN) Biopsy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant PD-1 Blockade in Patients With Stage IIB/C Melanoma|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||February 2026|
Experimental: Neoadjuvant Pembrolizumab
Subjects will receive one dose of pembrolizumab 200 mg. Approximately 3 weeks after the initial dose of pembrolizumab, subjects will undergo wide excision and sentinel lymph node (SLN) biopsy. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.
Pre-Surgery: Pembrolizumab, one 200mg dose; Post-Surgery: Pembrolizumab, 200 mg every 3 weeks.
Procedure: Wide Excision and Sentinel Lymph Node (SLN) Biopsy
Wide excision and SLN biopsy and pathologic assessment of tissue will be performed per standard of care.
- SLN Positivity Rate [ Time Frame: 3 Weeks ]To determine the SLN positivity rate and test whether the SLN positivity rate is reduced in high risk stage II patients undergoing neoadjuvant PD-1 blockade.
- Safety and Tolerability as measured by observed adverse events. [ Time Frame: Approximately 5 Years ]All observed adverse events which occur anytime from the initiation of study therapy to 30 days after the final dose of pembrolizumab will be graded and tabled.
- Disease-Free Survival (DFS) [ Time Frame: Approximately 5 Years ]Disease-free survival (DFS) is defined as the time from date of surgery to date of first documented disease progression, death due to any cause or last date that patient was documented to be disease-free (i.e., a scan date).
- Overall Survival [ Time Frame: Approximately 5 Years ]Overall survival (OS) is defined as the time from date of surgery to date of death due to any cause or last patient contact alive. Both DFS and OS outcomes will be measured from date of surgery to allow us to compare DFS and OS estimates with those of other adjuvant trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757689
|Contact: Giorgos Karakousis, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Giorgos Karakousis, MD 855-216-0098 email@example.com|
|Principal Investigator:||Giorgos Karakousis, MD||Abramson Cancer Center|