Safety and Efficacy of XmAb18087 Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer

  • End date
    Mar 15, 2024
  • participants needed
  • sponsor
    Xencor, Inc.
Updated on 15 October 2021
lung cancer
bispecific antibody


This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in subjects with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and XmAb18087 monotherapy in subjects with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.

Condition Neuroendocrine Carcinoma, small cell carcinoma of the lung, Neuroendocrine carcinoma, Merkel cell carcinoma, sclc, small cell carcinoma, Small Cell Lung Cancer
Treatment XmAb18087, XmAb18087 ± Pembrolizumab
Clinical Study IdentifierNCT04590781
SponsorXencor, Inc.
Last Modified on15 October 2021


Yes No Not Sure

Inclusion Criteria

Able to provide written informed consent
Adult subjects 18 years
Disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
All subjects must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded [FFPE] block[s] containing tumor that has not been previously irradiated
Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. success), or sexual abstinence
Fertile male subjects must be willing to practice a highly effective method of birth control for the duration of the study and continuing for 4 weeks after the last dose of XmAb18087 or pembrolizumab (when applicable
Able and willing to complete the entire study according to the study schedule
Additional Inclusion Criteria for Part A and Part B Cohorts
Histologically or cytologically confirmed metastatic MCC or locoregional MCC
that has recurred following standard locoregional therapy with surgery and/or
radiation therapy
Additional Inclusion Criteria for Part A Cohorts
Subjects must have progressed on or been ineligible for treatment with anti-
PD1 or anti-PDL1 therapy
Additional Inclusion Criteria for Part B Cohorts
Subjects must be eligible to receive pembrolizumab as standard of care
Additional Inclusion Criteria for Part C Cohorts
Histologically or cytologically confirmed extensive-stage SCLC that has
progressed following standard therapies

Exclusion Criteria

Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination
with Pembrolizumab In addition to the exclusion criteria in Section 8.6
subjects will be excluded from Part B safety run-in and expansion cohorts
administered XmAb18087 in combination with pembrolizumab if they meet the
following criteria
Prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-PD1) or anti-programmed cell death ligand 1 (anti-PDL1)
Have severe hypersensitivity ( Grade 3) to pembrolizumab and/or any of its excipients
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note