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Non-small Cell Lung Carcinoma (NSCLC)Phase 1NCT02346955

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)

A Phase 1 study testing CM-24 (MK-6018) and Pembrolizumab (MK-3475) in people with Non-small Cell Lung Carcinoma (NSCLC) and Melanoma, run by Famewave Ltd. at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CM-24 (MK-6018) and Pembrolizumab (MK-3475)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesin 2 countries
Study dates
Feb 2015to Feb 2017
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Call for Information (Investigational Site 0003)

    Los Angeles, California, 90095

  • Call for Information (Investigational Site 0004)

    New Haven, Connecticut, 06513

Other trials in United States

Israel1 site

  • Merck Sharp & Dohme Co. Ltd.

    Hod HaSharon

Other trials in Israel

About this study

Official title: 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.

Being tested
CM-24 (MK-6018), Pembrolizumab (MK-3475)
Keywords
Cancer, Oncology, cCAM Biotherapeutics Ltd, Immunomodulatory therapy, CM-24, Carcinoembryonic Antigen-related Cell Adhesion Molecule 1 (CEACAM1), NSCLC (adenocarcinoma), Uveal, Acral, Mucosal, Cutaneous, Colorectal, Gastric, Ovarian, Bladder, MK-6018-001
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Melanoma, Urinary Bladder Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM-24 (MK-6018)Biological

    Also called Anti-CEACAM1

    humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 by intravenous (IV) infusion

  • Pembrolizumab (MK-3475)Biological

    Also called KEYTRUDA®

    200 mg of Pembrolizumab by IV infusion

Study groups in NCT02346955
Study groupRoleWhat they receive
Cohort A Monotherapy Dose EscalationExperimentalParticipants will be enrolled in a staggered manner starting at a dose of 0.01 mg/kg of CM-24 (MK-6018) and continuing to 0.03, 0.1, 0.3, 1.0, 3.0, and 10 mg/kg to determine the recommended Phase 2 dose (RP2D). The dose will be escalated after a 6- to 8-week DLT window. Participants will be treated for 12 weeks during Cycle 1. Afterwards participants with clinical benefit and no dose-limiting toxicites (DLTs) are treated for up to 6 cycles.
Receives: Biological: CM-24 (MK-6018)
Cohort B Combination Dose EscalationExperimentalParticipants will be enrolled at the recommended phase 2 dose (RP2D) of CM-24 (MK-6018), determined by escalation studies, minus 1 dose level of MK-6018 in combination with a fixed dose of 200 mg pembrolizumab. Participants will be escalated to the RP2D of MK-6018 + 200 mg pembrolizumab. If the RP2D of MK-6018 + 200 mg pembrolizumab is not tolerated, the dose of MK-6018 will be de-escalated but will not fall below 1 mg/kg. Participants will be treated for 6 weeks during Cycle 1 and 2. Afterwards participants with clinical benefit and no DLTs are treated for up to 35 cycles.
Receives: Biological: CM-24 (MK-6018); Biological: Pembrolizumab (MK-3475)
Cohort C Monotherapy ExpansionExperimentalParticipants with advanced or recurrent cutaneous melanoma will be enrolled and treated at the recommended phase 2 dose of CM-24 (MK-6018) for up to 17 cycles.
Receives: Biological: CM-24 (MK-6018)
Cohort D Monotherapy ExpansionExperimentalParticipants with advanced or recurrent colorectal cancer will be enrolled and treated at the recommended phase 2 dose of CM-24 (MK-6018) for up to 17 cycles.
Receives: Biological: CM-24 (MK-6018)
Cohort E Monotherapy ExpansionExperimentalParticipants with advanced or recurrent gastric cancer will be enrolled and treated at the recommended phase 2 dose of CM-24 (MK-6018) for up to 17 cycles.
Receives: Biological: CM-24 (MK-6018)
Cohort C1 Combination ExpansionExperimentalParticipants with advanced or recurrent cutaneous melanoma will be enrolled and treated at the recommended phase 2 dose of CM-24+ 200 mg of Pembrolizumab for up to 17 cycles and may continue to receive 200 mg of Pembrolizumab as monotherapy for up to an additional 18 cycles (up to 35 total cycles).
Receives: Biological: CM-24 (MK-6018); Biological: Pembrolizumab (MK-3475)
Cohort D1 Combination ExpansionExperimentalParticipants with advanced or recurrent colorectal cancer will be enrolled and treated at the recommended phase 2 dose of CM-24+ 200 mg of Pembrolizumab for up to 17 cycles and may continue to receive 200 mg of Pembrolizumab as monotherapy for up to an additional 18 cycles (up to 35 total cycles).
Receives: Biological: CM-24 (MK-6018); Biological: Pembrolizumab (MK-3475)
Cohort E1 Combination ExpansionExperimentalParticipants with advanced or recurrent gastric cancer will be enrolled and treated at the recommended phase 2 dose of CM-24+ 200 mg of Pembrolizumab for up to 17 cycles and may continue to receive 200 mg of Pembrolizumab as monotherapy for up to an additional 18 cycles (up to 35 total cycles).
Receives: Biological: CM-24 (MK-6018); Biological: Pembrolizumab (MK-3475)
Cohort F Combination ExpansionExperimentalParticipants with advanced or recurrent non-small cell lung adenocarcinoma will be enrolled and treated at the recommended phase 2 dose of CM-24+ 200 mg of Pembrolizumab for up to 17 cycles and may continue to receive 200 mg of Pembrolizumab as monotherapy for up to an additional 18 cycles (up to 35 total cycles).
Receives: Biological: CM-24 (MK-6018); Biological: Pembrolizumab (MK-3475)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events (AEs)

    Measured: From time of first dose until the end of follow-up (up to 123 weeks)

  2. Number of participants discontinuing study drug due to AEs

    Measured: From time of first dose until the end of follow-up (up to 105 weeks)

  3. Number of participants with a Dose Limiting Toxicity (DLT)

    Measured: From time of first dose until the end of follow-up (up to 12 weeks)

Secondary outcomes (7)

  1. Maximum drug concentration in serum/plasma (Cmax)

    Measured: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.

  2. Time to reach Cmax in serum/plasma (Tmax)

    Measured: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.

  3. Terminal-phase elimination half-life in serum/plasma (t1/2)

    Measured: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.

  4. Area under the plasma/serum concentration versus time curve from time zero to the last measured time (AUC 0-T)

    Measured: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.

  5. Area under the plasma/serum concentration versus time curve from time zero to infinity (AUC 0-∞)

    Measured: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.

  6. Objective Response Rate (ORR) defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

    Measured: From time of screening until the end of follow-up (up to 123 weeks)

  7. Time from ORR to disease progression or death (DOR)

    Measured: From time of screening until the end of follow-up (up to 123 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346955
Sponsor's protocol ID
6018-001
Other IDs
CB-24-01, MK-6018-001
Status last verified
Aug 2020
First submitted
9 Dec 2014
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CM-24 (MK-6018) and Pembrolizumab (MK-3475) in people with Non-small Cell Lung Carcinoma (NSCLC) and Melanoma, run by Famewave Ltd. at 3 sites in 2 countries.

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 13 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Israel. 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 was stopped early. Results are not available in the source record.

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?

Number of participants with Adverse Events (AEs) (time frame: From time of first dose until the end of follow-up (up to 123 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02346955.

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 27 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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