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)

Stopped early · Phase 1

Conditions studied: Non-small Cell Lung Carcinoma (NSCLC), Melanoma, Bladder Cancer, Colorectal Cancer, Gastric Cancer, Ovarian Cancer

In brief

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.

Key facts

Study ID: NCT02346955
Run by: Famewave Ltd.
People needed: 27
Starts: 2015-02-01
Expected to finish: 2017-02-01
Last updated by the study team: 2020-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Call for Information (Investigational Site 0003) — Los Angeles, California, United States
Call for Information (Investigational Site 0004) — New Haven, Connecticut, United States
Merck Sharp & Dohme Co. Ltd. — Hod HaSharon, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.