NCT04708418|Active Not RecruitingPhase 2FDA Drug

A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma

Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination With CMP-001 in Patients With Operable Melanoma: Efficacy and Biomarker Study

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2020-14174EA6194U10CA180820

Study Type

interventional

Target

Locations

1 country

Sites

188

Timeline

RegisteredJan 2021

StartedOct 2021

CompletionDec 2026

Brief Summary

This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). 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. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

6mo left

Started Oct 2021

Longer than P75 for phase_2

Geographic Reach

1 country

188 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

5.2 years study duration

Study Progress90%

Oct 2021Dec 2026

First Submitted

Initial submission to the registry

January 13, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed

9 months until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

5.2 years

First QC Date

January 13, 2021

Last Update Submit

May 13, 2026

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8 Recurrent Cutaneous Melanoma Melanoma of Unknown Primary Pathologic Stage IIIB Cutaneous Melanoma AJCC v8

Outcome Measures

Primary Outcomes (1)

Pathologic complete response rate
Will be estimated by the percentage of patients who achieve complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) and Immune-Modified RECIST criteria, with exact 90% confidence intervals.
Up to 15 years

Secondary Outcomes (4)

Radiographic response rate
Up to 15 years
Relapse-free survival
From randomization to relapse or death (whichever occurs first), assessed up to 15 years
Overall survival
From randomization to death from any cause, assessed up to 15 years
Incidence of adverse events
Up to 30 days after the last study drug administration

Study Arms (2)

Arm A (pembrolizumab)

EXPERIMENTAL

NEOADJUVANT PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase. ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyBiological: PembrolizumabProcedure: Positron Emission TomographyProcedure: Surgical Procedure

Arm B (CMP-001, pembrolizumab)

EXPERIMENTAL

NEOADJUVANT PHASE: Patients receive CMP-001 SC on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1, days 1, 8, and 15 of cycle 2, and day 1 of cycle 3. Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase. ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyBiological: PembrolizumabProcedure: Positron Emission TomographyProcedure: Surgical ProcedureDrug: VLP-encapsulated TLR9 Agonist CMP-001

Interventions

Surgical ProcedurePROCEDURE

Undergo surgery

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Arm A (pembrolizumab)Arm B (CMP-001, pembrolizumab)

VLP-encapsulated TLR9 Agonist CMP-001DRUG

Given SC or intratumorally

Arm B (CMP-001, pembrolizumab)

Biopsy ProcedurePROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Arm A (pembrolizumab)Arm B (CMP-001, pembrolizumab)

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm A (pembrolizumab)Arm B (CMP-001, pembrolizumab)

PembrolizumabBIOLOGICAL

Given IV

Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475

Arm A (pembrolizumab)Arm B (CMP-001, pembrolizumab)

Computed TomographyPROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm A (pembrolizumab)Arm B (CMP-001, pembrolizumab)

Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm A (pembrolizumab)Arm B (CMP-001, pembrolizumab)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient must be \>= 18 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient must have a histologic diagnosis of melanoma belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages:
T0, Tx or T1-4; and
N1b, N2b, N2c, N3b or N3c
Patients may have a presentation with primary melanoma with concurrent regional nodal and/or in-transit metastasis; or patients may have a history of primary melanoma or unknown primary melanoma presenting with clinically detected regional nodal and/or in-transit recurrence; and may belong to any of the following groups:
Primary cutaneous melanoma with clinically apparent regional lymph node metastases and/or in-transit metastases
Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
Primary cutaneous melanoma with concurrent nodal disease involving a single (or multiple) regional nodal group(s) if considered potentially surgically resectable at baseline
Clinically detected nodal melanoma (if single site) arising from an unknown primary
In-transit cutaneous metastases with or without regional lymph node involvement permitted if considered potentially surgically resectable at baseline
NOTE: Patients with mucosal and/or uveal melanoma are not eligible for the study
Patient must be a candidate for definitive surgery and have met with the treating surgical oncologist prior to randomization
Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist \[registered trademark\] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
Patient must have the presence of injectable and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, documented by scans obtained within 4 weeks prior to randomization
+31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (188)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Alaska Breast Care and Surgery LLC