Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Participants With Advanced Melanoma
Status: | Recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/16/2018 |
Start Date: | May 4, 2017 |
End Date: | December 2019 |
Contact: | Dave Mauro, MD, PhD |
Email: | dmauro@checkmatepharma.com |
Phone: | 617-531-8260 |
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:
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.
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.
Inclusion Criteria:
• Participants enrolled into Part 1 must have tumor lesions where repeated IT injections
are not feasible and in whom,based on the Ivestigator'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 tumor lesions that are amenable to repeated IT injections.
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.
- Either a) Participants currently receiving treatment with the anti-PD-1 antibody
pembrolizumab either alone or in combination. Participants must have a best response
of either Stable Disease (SD) or Progressive Disease (PD) per RECIST Version 1.1 while
on pembrolizumab.
- Participants who have had SD must have been on pembrolizumab for at least 12
weeks.
- There is no minimum treatment duration for participants who have PD while on
pembrolizumab.
- Or b) Participants who have previously received any anti-PD-1/PD-L1 therapy, alone or
in combination, and who were deemed to have not responded (that is, best response of
SD or PD) to this therapy/combination irrespective of the timing of the prior therapy
relative to first dose of CMP-001.
- Participants must have measurable disease by RECIST Version 1.1.
- Capable of understanding and complying with protocol requirements.
- 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:
1. 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).
2. 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.
3. Lactate dehydrogenase (LDH) <=2.0 times the ULN range of each institution.
4. 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.
Exclusion Criteria:
- 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.
- 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.
We found this trial at
4
sites
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Mohammed Milhem, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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