Study of CM-24 (MK-6018) Alone and In Combination With Pembrolizumab (MK-3475) in Participants With Selected Advanced or Recurrent Malignancies (MK-6018-001)
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Bladder Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2017 |
Start Date: | February 2015 |
End Date: | February 2017 |
A Phase 1, Open-Label, Multicenter, Multi-Dose Escalation Study of CM-24 (MK-6018) as Monotherapy and In Combination With Pembrolizumab (MK-3475) in Subjects With Selected Advanced or Recurrent Malignancies
The purpose of this study is to evaluate the safety and tolerability of humanized IgG4
(kappa) isotype monoclonal antibody against CEACAM1 (CM-24 [MK-6018]), administered
intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in
participants with selected advanced or recurrent malignancies. Escalating multiple doses
will be evaluated to determine the recommended dose for Phase 2 clinical studies.
(kappa) isotype monoclonal antibody against CEACAM1 (CM-24 [MK-6018]), administered
intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in
participants with selected advanced or recurrent malignancies. Escalating multiple doses
will be evaluated to determine the recommended dose for Phase 2 clinical studies.
Inclusion Criteria:
- Males and females ≥18 years of age
- Participants in the Dose Escalation portion must have one of the following advanced
or recurrent malignancies: gastrointestinal (colorectal or gastric); ovarian;
melanoma; non-small cell lung adenocarcinoma; or bladder.
- Participants in the Monotherapy Expansion Cohort must have one of the following
advanced or recurrent malignancies: cutaneous melanoma showing primary progression
following treatment with an anti-programmed cell death (PD) or anti-PDL1 regimen; or
anti-PD1 or anti-PD-L1 treatment-naïve colorectal or gastric cancer, including
gastroesophageal junction cancer of Siewert Type II and Type III.
- Participants in the Combination Expansion Cohorts must have one of the following
advanced or recurrent malignancies: non-small cell lung adenocarcinoma or cutaneous
melanoma showing primary progression following treatment with an anti-PD1 or
anti-PD-L1 regimen; or anti-PD1 or anti-PD-L1 treatment-naïve colorectal or gastric
cancer, including gastroesophageal junction cancer of Siewert Type II and Type III.
- Melanoma with BRAF V600E or V600K mutation-positive melanoma must have progressed on,
or were intolerant to, prior BRAF- or MEK-inhibitor therapy
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 with progressing or new tumors since last antitumor therapy
- Must have adequate hematologic, renal, and liver function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Females must not be pregnant (negative human chorionic gonadotropin test within 72
hours prior to receiving the first dose of study medication) or breastfeeding
- Women of childbearing potential and male participants must agree to use adequate
contraception throughout the study and for up to 180 days after study treatment
- An estimated life expectancy of at least 3 months
- Must consent to provide an archival tumor biopsy sample at any time point from
screening to study exit
- Must consent to allow the acquisition of new tissue biopsy samples during the study
Exclusion Criteria:
- History of severe hypersensitivity reactions or immune related adverse events to
other monoclonal antibodies
- History of other active malignancy within the prior 2 years
- History of insulin-dependent or uncontrolled Diabetes Mellitus
- History of inflammatory bowel disease
- Autoimmune disorders
- Known HIV and/or Hepatitis B or C infections
- Known systemic bleeding or platelet disorder
- Receipt of live vaccines with 4 weeks (28 days) of study
- History or evidence of non-infectious pneumonitis that required steroids or current
pneumonitis
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