CMP-001-002 is a Phase 1b study of CMP-001 administered to participants with advanced melanoma who are either receiving pembrolizumab, or who have previously received an anti-programmed cell death protein 1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) therapy for advanced melanoma, and who have not responded (that is, immunotherapy resistant). This study will be conducted in two parts: Part 1 will consist of a Dose Escalation Phase and a Dose Expansion Phase * Dose Escalation Phase will be conducted to assess and identify a recommended phase 2 dose (RP2D) of CMP-001 for subcutaneous (SC) administration * The Dose Expansion Phase is intended to further characterize the safety, pharmacodynamics, and preliminary evidence of antitumor activity of the RP2D of CMP-001 administered SC in combination with pembrolizumab Part 2 will assess the safety and preliminary evidence of antitumor activity of CMP-001, administered both SC and intratumoral (IT) when given in combination with pembrolizumab. Participants will continue treatment with CMP-001 in combination with pembrolizumab as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator.
Former Sponsor Checkmate Pharmaceuticals
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CMP-001 will be administered SC as per the dose and schedule specified in the respective arms.
Pembrolizumab will be administered as per the schedule specified in the respective arms.
CMP-001 will be administered IT as per the dose and schedule specified in the respective arms.
University of California, Los Angeles
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Pittsburgh Medical Center - Cancer Center
Pittsburgh, Pennsylvania, United States
Part 1: Dose-Escalation Phase: RP2D of CMP-001 When Administered SC and Given in Combination With Pembrolizumab
Time frame: 15 days from date of first CMP-001 injection (Week 1 Day 1)
Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion: Number of Participants With TEAEs
TEAEs will be evaluated using CTCAE version 5.0.
Time frame: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Oral Temperature
Oral temperature should be measured in supine or seated position, following at least 30 minutes of rest.
Time frame: From screening up to end of treatment (EOT) (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Respiratory Rate
Respiratory rate should be measured in supine or seated position, following at least 30 minutes of rest.
Time frame: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Systolic and Diastolic Blood Pressure
Blood pressure should be measured in supine or seated position, following at least 30 minutes of rest.
Time frame: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Body Weight
Physical examination included body weight measurement.
Time frame: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Body Mass Index (BMI)
Physical examination included BMI measurement.
Time frame: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters
ECG parameters will include heart rate and PR, QRS, QT, and QT corrected for heart rate (QTc) intervals. QT will be corrected using Fridericia's (QTcF) formula. ECG will be performed after the participant has been resting in supine or semi-supine position for at least 5 minutes.
Time frame: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Clinical laboratory parameters includes serum chemistry, hematology, urinalysis, coagulation and thyroid function tests.
Time frame: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation: Concentration of Chemokine IP-10
Time frame: Day 1 of Weeks 1, 3, 15 and Day 2 of Week 3, 15
Part 1 and Part 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Using Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) Scans
ORR will be calculated as the number of participants with a confirmed complete response (CR) or partial response (PR) divided by the number of participants dosed.
Time frame: Baseline until confirmed disease progression (CR or PR) or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Best Overall Response (BOR) Rate (Percentage of Participants With Best Objective Response of CR or PR) as per RECIST Version 1.1 Using CT or MRI Scans
BOR will be calculated as the number of participants with best response of CR or PR divided by the number of participants dosed.
Time frame: Baseline until confirmed disease progression (CR or PR) or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Time to Response (TTR) as per RECIST Version 1.1 Using CT or MRI Scans
Time frame: From first dose of CMP-001 until disease progression or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 2.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2: Duration of Response (DOR) as per RECIST Version 1.1 Using CT or MRI Scans
Time frame: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 2.5 years)
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