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.
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
- Conditions the study is for
- Non-small Cell Lung Carcinoma (NSCLC), Melanoma, Bladder Cancer
- 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
Show all 13Show fewer
- 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
Show all 9Show fewer
- 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
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.
- Conditions
- Non-small Cell Lung Carcinoma (NSCLC), Melanoma, Bladder Cancer, Colorectal Cancer, Gastric Cancer, Ovarian Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Cohort A Monotherapy Dose Escalation | Experimental | Participants 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 Escalation | Experimental | Participants 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 Expansion | Experimental | Participants 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 Expansion | Experimental | Participants 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 Expansion | Experimental | Participants 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 Expansion | Experimental | Participants 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 Expansion | Experimental | Participants 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 Expansion | Experimental | Participants 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 Expansion | Experimental | Participants 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.
Number of participants with Adverse Events (AEs)
Measured: From time of first dose until the end of follow-up (up to 123 weeks)
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)
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)
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.
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.
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.
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.
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.
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)
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.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Carcinoma (NSCLC)Studies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Famewave Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02346955
- Acronym / sponsor ID
- 6018-001
- Conditions
- Non-small Cell Lung Carcinoma (NSCLC), Melanoma, Bladder Cancer, Colorectal Cancer, Gastric Cancer, Ovarian Cancer
- Keywords
- Cancer, Oncology, cCAM Biotherapeutics Ltd, Immunomodulatory therapy, CM-24, Carcinoembryonic Antigen-related Cell Adhesion Molecule 1 (CEACAM1), NSCLC (adenocarcinoma), Uveal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Famewave Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 27 Jan 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort A Monotherapy Dose Escalation | Experimental | Biological: CM-24 (MK-6018)Participants 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. |
| Cohort B Combination Dose Escalation | Experimental | Biological: CM-24 (MK-6018), Biological: Pembrolizumab (MK-3475)Participants 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. |
| Cohort C Monotherapy Expansion | Experimental | Biological: CM-24 (MK-6018)Participants 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. |
| Cohort D Monotherapy Expansion | Experimental | Biological: CM-24 (MK-6018)Participants 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. |
| Cohort E Monotherapy Expansion | Experimental | Biological: CM-24 (MK-6018)Participants 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. |
| Cohort C1 Combination Expansion | Experimental | Biological: CM-24 (MK-6018), Biological: Pembrolizumab (MK-3475)Participants 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). |
| Cohort D1 Combination Expansion | Experimental | Biological: CM-24 (MK-6018), Biological: Pembrolizumab (MK-3475)Participants 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). |
| Cohort E1 Combination Expansion | Experimental | Biological: CM-24 (MK-6018), Biological: Pembrolizumab (MK-3475)Participants 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). |
| Cohort F Combination Expansion | Experimental | Biological: CM-24 (MK-6018), Biological: Pembrolizumab (MK-3475)Participants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| CM-24 (MK-6018)Also: Anti-CEACAM1humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 by intravenous (IV) infusion | Biological | Cohort A Monotherapy Dose Escalation, Cohort B Combination Dose Escalation, Cohort C Monotherapy Expansion, Cohort C1 Combination Expansion, Cohort D Monotherapy Expansion, Cohort D1 Combination Expansion, Cohort E Monotherapy Expansion, Cohort E1 Combination Expansion, Cohort F Combination Expansion |
| Pembrolizumab (MK-3475)Also: KEYTRUDA®200 mg of Pembrolizumab by IV infusion | Biological | Cohort B Combination Dose Escalation, Cohort C1 Combination Expansion, Cohort D1 Combination Expansion, Cohort E1 Combination Expansion, Cohort F Combination Expansion |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: From time of first dose until the end of follow-up (up to 123 weeks)
Number of participants discontinuing study drug due to AEs
Time frame: From time of first dose until the end of follow-up (up to 105 weeks)
Number of participants with a Dose Limiting Toxicity (DLT)
Time frame: From time of first dose until the end of follow-up (up to 12 weeks)
7 secondary outcomes
Maximum drug concentration in serum/plasma (Cmax)
Time frame: 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.
Time to reach Cmax in serum/plasma (Tmax)
Time frame: 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.
Terminal-phase elimination half-life in serum/plasma (t1/2)
Time frame: 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.
Area under the plasma/serum concentration versus time curve from time zero to the last measured time (AUC 0-T)
Time frame: 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.
Area under the plasma/serum concentration versus time curve from time zero to infinity (AUC 0-∞)
Time frame: 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.
Objective Response Rate (ORR) defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Time frame: From time of screening until the end of follow-up (up to 123 weeks)
Time from ORR to disease progression or death (DOR)
Time frame: From time of screening until the end of follow-up (up to 123 weeks)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 2 countries: see every site and its status.
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?
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.