Trial Outcomes & Findings for A Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma (NCT NCT02434354)

NCT ID: NCT02434354

Last Updated: 2022-06-16

Results Overview

Safety as defined by 1) all grade 3/4 adverse events and 2) any grade adverse event that occurred in\>5% of patients. Toxicities are graded using CTCAE Version 4.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 33 participants
• Primary outcome timeframe: within 30 days of final study treatment
• Results posted on: 2022-06-16

Participant Flow

Participant milestones

Measure	Neo-adjuvant/Adjuvant Pembrolizumab 200mgIV Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Overall Study STARTED	33
Overall Study Post Consent Screening	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Neo-adjuvant/Adjuvant Pembrolizumab 200mgIV Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Overall Study screen fail	3

Baseline Characteristics

A Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma

Baseline characteristics by cohort

Measure	Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV n=30 Participants Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Stage at Study Entry Stage IIIB	12 participants n=5 Participants
Stage at Study Entry Stage IIIC	17 participants n=5 Participants
Stage at Study Entry Stage IV	1 participants n=5 Participants
Baseline LDH Normal	30 participants n=5 Participants
Baseline LDH Elevated	29 participants n=5 Participants
Baseline LDH No Data	1 participants n=5 Participants
Primary Site cutaneous	24 participants n=5 Participants
Primary Site unknown	6 participants n=5 Participants
BRAF V600 Wild Type	9 participants n=5 Participants
BRAF V600 Mutant	7 participants n=5 Participants
BRAF V600 Unknown	14 participants n=5 Participants
Prior Therapy PLX4032	1 participants n=5 Participants
Prior Therapy None	29 participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days of final study treatment

Safety as defined by 1) all grade 3/4 adverse events and 2) any grade adverse event that occurred in>5% of patients. Toxicities are graded using CTCAE Version 4.

Outcome measures

Measure	Neo-adjuvant/Adjuvant Pembrolizaumab 200 mg IV n=30 Participants All subjects will receive 1 cycle neo-adjuvant pembrolizumab 200mg IV followed by complete surgical resection followed by pembrolizumab Q3weeks for 1 year pembrolizumab: 200 mg Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete resection and then a year of adjuvant pembrolizumab
Number of Participants (%) With CTCAE Graded Adverse Events	6 Participants

Adverse Events

Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV

Serious events: 6 serious events

Other events: 2 other events

Deaths: 6 deaths

Serious adverse events

Measure	Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV n=30 participants at risk Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Immune system disorders Anaphylaxis	3.3% 1/30 • Number of events 1 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.
Gastrointestinal disorders esophageal obstruction	3.3% 1/30 • Number of events 1 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.
Gastrointestinal disorders colitis	3.3% 1/30 • Number of events 1 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.
Immune system disorders Enteritis	3.3% 1/30 • Number of events 1 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.
Infections and infestations wound infection	3.3% 1/30 • Number of events 1 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.
Infections and infestations sepsis	3.3% 1/30 • Number of events 2 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.

Other adverse events

Measure	Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV n=30 participants at risk Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
Skin and subcutaneous tissue disorders Rash	6.7% 2/30 • Number of events 3 • 15 months All SAEs are reported. Grade 3-5 AEs and SAEs and occurring in at least 5% of subjects are reported.

Additional Information

Dr. Tara Mitchell

Abramson Cancer Center

Phone: 215-662-7908

Email: tara.mitchell@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place