NCT02775851|Active Not RecruitingPhase 2ResultsFDA Drug

Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery

A Phase II and Pilot Trial of PD-1 Blockade With Pembrolizumab (MK-3475) in Patients With Resectable or Unresectable Desmoplastic Melanoma (DM)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2016-00666S1512U10CA180888

Study Type

interventional

Target

Locations

1 country

Sites

281

Timeline

RegisteredMay 2016

StartedFeb 2017

CompletionMay 2026

Brief Summary

This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can be removed by surgery (resectable) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

0mo left

Started Feb 2017

Longer than P75 for phase_2

Geographic Reach

1 country

281 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

First Submitted

Initial submission to the registry

May 16, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed

9 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed

1 year until next milestone

Results Posted

Study results publicly available

April 23, 2024

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected

Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6.2 years

First QC Date

May 16, 2016

Results QC Date

February 16, 2024

Last Update Submit

April 9, 2026

Conditions

Desmoplastic Melanoma

Outcome Measures

Primary Outcomes (2)

Pathologic Complete Response (pCR) Rate (Cohort A)
Pathologic complete response is defined as no evidence of viable tumor cells on complete pathological evaluation of the surgical specimen per institutional standard of care.
Up to 5 years
Complete Response (CR) Rate (Cohort B)
Complete response (per RECIST 1.1) defined as: disappearance of all target and non-target lesions no new lesions, no disease related symptoms, and any lymph nodes must have reduction in short axis to \< 1.0 cm.
Up to 5 years

Secondary Outcomes (4)

9 Week Response Rate (Cohort A)
Up to 3 months
Overall Survival (Cohort A and B)
Up to 5 years
Progression Free Survival (Cohort B)
Up to 5 years
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Duration of treatment and follow-up until death or 5 years post registration.

Other Outcomes (5)

Baseline Mutational Load (Cohort A and B)
Up to 5 years
Change in T-cell Infiltration (Cohort A and B)
Up to 5 years
ctDNA Fraction
Up to 5 years
+2 more other outcomes

Study Arms (2)

Cohort A (pembrolizumab, surgery)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles. Patients with potentially resectable disease undergo surgery. Patients with tumor progression and unresectable disease may receive one additional cycle of pembrolizumab. Patients undergo CT scan and may undergo PET and MRI throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ElastographyBiological: PembrolizumabProcedure: Positron Emission TomographyProcedure: Therapeutic Conventional Surgery

Cohort B (pembrolizumab)

EXPERIMENTAL

Patients with unresectable disease receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or toxicity. Patients undergo CT scan and may undergo PET and MRI throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyBiological: PembrolizumabProcedure: Positron Emission TomographyProcedure: Therapeutic Conventional Surgery