Malignant MelanomaPhase 1NCT03084640
Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Participants With Advanced Melanoma
A Phase 1 study testing CMP-001 and Pembrolizumab in people with Malignant Melanoma, run by Regeneron Pharmaceuticals at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- CMP-001 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 May 2017to 30 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants enrolled into Part 1 must have tumor lesions where repeated IT injections are not feasible and in whom, based on the Investigator's judgement, SC injection is the only viable route of CMP-001 administration. Participants with lesions that are easily accessible for IT injections are not eligible to participate in Part 1. Participants enrolled into Part 2 must have at least one tumor lesion with a longest diameter of >/= 0.5 cm amenable for IT injection of CMP-001.
- All participants enrolled into either Part 1 or Part 2 must meet all of the following inclusion criteria to be eligible:
- Histopathologically confirmed diagnosis of metastatic or unresectable malignant melanoma. Ocular melanoma participants are not eligible.
- Participants must have received prior treatment with anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and had documented progression per RECIST. Participants must have received at least 4 doses of anti-PD-1 or anti-PD-L1 therapy.
- Participants must have measurable disease by RECIST Version 1.1.
- Capable of understanding and complying with protocol requirements.
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- A life expectancy of greater than 24 weeks at Screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Most recent laboratory values (within 3 weeks prior to Week 1 Day 1) meet the following standards:
- Bone marrow function: neutrophil count greater than or equal to (>/=) 1,000/cubic millimeter (mm^3), platelet count >/=75,000/mm^3 and hemoglobin concentration >/= 8.0 grams per deciliter (g/dL).
- Liver function: total bilirubin less than or equal to (<=) 1.5 times the upper limit of normal (ULN) of each institution, aspartate aminotransferase and alanine aminotransferase <=3 times the ULN range of each institution.
- Lactate dehydrogenase (LDH) <=2.0 times the ULN range of each institution.
- Renal function: serum creatinine <=1.5 times the ULN range of each institution.
- The participant must sign a written informed consent form prior to the initiation of any study procedures. Adult participants unable to provide written informed consent on their own behalf will not be eligible for the study.
Who cannot join
- Pregnant or breast feeding
- Received investigational therapy (that is, small molecule or biologic) within 30 days prior to the start of CMP-001 dosing on Week 1 Day 1. However, if an investigational drug has a short half-life, a reduced wash out period may be acceptable upon permission given by the Sponsor.
- Received treatment with anti- cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody within 30 days prior to the start of CMP-001 dosing on Week 1 Day 1.
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Developed autoimmune disorders of Grade 4 while on prior immunotherapy. Participants who developed autoimmune disorders of Grade <=3 may enroll if the disorder has resolved to Grade <=1 and the participant has been off systemic steroids at doses greater than (>) 10 milligrams per day (mg/day) for at least 2 weeks.
- Require systemic pharmacologic doses of corticosteroids at or above the equivalent of 10 mg/day prednisone; replacement doses, topical, ophthalmologic and inhalational steroids are permitted. Participants who have a history of adrenal insufficiency and are receiving greater than 10 mg/day systemic steroids may be eligible but only after Sponsor consultation. Participants who are currently receiving steroids at a dose of <=10 mg/day do not need to discontinue steroids prior to enrollment.
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- Active (that is, symptomatic or growing) central nervous system (CNS) metastases. Participants with CNS metastases are eligible for the trial if: a) the metastases have been treated by surgery and/or radiotherapy; b) the participant is off corticosteroids >10 mg/day and is neurologically stable for at least 2 weeks prior to Screening; c) brain MRI completed within 3 months of Screening.
- Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the participant unable to cooperate or participate in the trial.
- Severe uncontrolled cardiac disease within 6 months of screening, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).
- Requires prohibited treatment that is, non-protocol specified anticancer. pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor)
- Women of child-bearing potential who are unable or unwilling to use an acceptable method of contraception.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado
Aurora, Colorado, 80045
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California, Los Angeles
Los Angeles, California, 90095
University of Pittsburgh Medical Center - Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Multicenter, Two Part, Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Subjects With Advanced Melanoma
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:
Read more
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.
Read the detailed description
Former Sponsor Checkmate Pharmaceuticals
- Conditions
- Malignant Melanoma
- Being tested
- CMP-001, Pembrolizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMP-001Drug
CMP-001 will be administered SC as per the dose and schedule specified in the respective arms.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered as per the schedule specified in the respective arms.
CMP-001Drug
CMP-001 will be administered IT as per the dose and schedule specified in the respective arms.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose-Escalation - CMP-001 (SC) and Pembrolizumab | Experimental | Participants will receive up to 7 escalating dose levels (5 milligrams [mg], 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, and 20 mg) of CMP-001 via SC injection once a week for 3 weeks and every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. Receives: Drug: CMP-001; Drug: Pembrolizumab |
| Part 1: Dose-Expansion - CMP-001 (SC) and Pembrolizumab | Experimental | Participants will receive RP2D (as determined in Part 1 dose-escalation phase) of CMP-001 via SC injection once a week for 3 weeks and every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. Receives: Drug: CMP-001; Drug: Pembrolizumab |
| Part 2: CMP-001 (SC and IT) and Pembrolizumab | Experimental | Participants will receive CMP-001 via SC injection once weekly for 2 weeks, then IT injection once weekly for 4 weeks, and SC injection once weekly for every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. CMP-001 planned IT dose level in Part 2 will be up to 10 mg and the SC dose will be the RP2D determined from Part 1 dose-escalation phase of the study. Receives: Drug: CMP-001; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Dose-Escalation Phase: RP2D of CMP-001 When Administered SC and Given in Combination With Pembrolizumab
Measured: 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.
Measured: 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)
Secondary outcomes (13)
Part 1 Dose Escalation and Dose Expansion: Number of Participants With TEAEs
TEAEs will be evaluated using CTCAE version 5.0.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From screening up to EOT (up to approximately 2.5 years)
Part 1 Dose Escalation: Concentration of Chemokine IP-10
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start4 May 2017
- Primary completion2 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084640
- Sponsor's protocol ID
- CMP-001-002
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2017
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Two Part, Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03084640
- Acronym / sponsor ID
- CMP-001-002
- Conditions
- Malignant Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 May 2017 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Former Sponsor Checkmate Pharmaceuticals
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose-Escalation - CMP-001 (SC) and Pembrolizumab | Experimental | Drug: CMP-001, Drug: PembrolizumabParticipants will receive up to 7 escalating dose levels (5 milligrams [mg], 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, and 20 mg) of CMP-001 via SC injection once a week for 3 weeks and every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. |
| Part 1: Dose-Expansion - CMP-001 (SC) and Pembrolizumab | Experimental | Drug: CMP-001, Drug: PembrolizumabParticipants will receive RP2D (as determined in Part 1 dose-escalation phase) of CMP-001 via SC injection once a week for 3 weeks and every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. |
| Part 2: CMP-001 (SC and IT) and Pembrolizumab | Experimental | Drug: CMP-001, Drug: PembrolizumabParticipants will receive CMP-001 via SC injection once weekly for 2 weeks, then IT injection once weekly for 4 weeks, and SC injection once weekly for every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. CMP-001 planned IT dose level in Part 2 will be up to 10 mg and the SC dose will be the RP2D determined from Part 1 dose-escalation phase of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants enrolled into Part 1 must have tumor lesions where repeated IT injections are not feasible and in whom, based on the Investigator's judgement, SC injection is the only viable route of CMP-001 administration. Participants with lesions that are easily accessible for IT injections are not eligible to participate in Part 1. Participants enrolled into Part 2 must have at least one tumor lesion with a longest diameter of >/= 0.5 cm amenable for IT injection of CMP-001.
- All participants enrolled into either Part 1 or Part 2 must meet all of the following inclusion criteria to be eligible:
- Histopathologically confirmed diagnosis of metastatic or unresectable malignant melanoma. Ocular melanoma participants are not eligible.
- Participants must have received prior treatment with anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and had documented progression per RECIST. Participants must have received at least 4 doses of anti-PD-1 or anti-PD-L1 therapy.
- Participants must have measurable disease by RECIST Version 1.1.
Key exclusion criteria (11 listed)
- Pregnant or breast feeding
- Received investigational therapy (that is, small molecule or biologic) within 30 days prior to the start of CMP-001 dosing on Week 1 Day 1. However, if an investigational drug has a short half-life, a reduced wash out period may be acceptable upon permission given by the Sponsor.
- Received treatment with anti- cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody within 30 days prior to the start of CMP-001 dosing on Week 1 Day 1.
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Developed autoimmune disorders of Grade 4 while on prior immunotherapy. Participants who developed autoimmune disorders of Grade <=3 may enroll if the disorder has resolved to Grade <=1 and the participant has been off systemic steroids at doses greater than (>) 10 milligrams per day (mg/day) for at least 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMP-001CMP-001 will be administered SC as per the dose and schedule specified in the respective arms. | Drug | Part 1: Dose-Escalation - CMP-001 (SC) and Pembrolizumab, Part 1: Dose-Expansion - CMP-001 (SC) and Pembrolizumab, Part 2: CMP-001 (SC and IT) and Pembrolizumab |
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered as per the schedule specified in the respective arms. | Drug | Part 1: Dose-Escalation - CMP-001 (SC) and Pembrolizumab, Part 1: Dose-Expansion - CMP-001 (SC) and Pembrolizumab, Part 2: CMP-001 (SC and IT) and Pembrolizumab |
| CMP-001CMP-001 will be administered IT as per the dose and schedule specified in the respective arms. | Drug | Part 2: CMP-001 (SC and IT) and Pembrolizumab |
Primary outcome
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)
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)
TEAEs will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
13 secondary outcomes
Part 1 Dose Escalation and Dose Expansion: Number of Participants With TEAEs
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
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
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
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
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)
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
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
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMP-001 and Pembrolizumab in people with Malignant Melanoma, run by Regeneron Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.