Merkel Cell CarcinomaPhase 1/2NCT04590781
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer
A Phase 1/2 study testing XmAb18087 and XmAb18087 ± Pembrolizumab in people with Merkel Cell Carcinoma and Small Cell Lung Cancer, run by Xencor, Inc. at 7 sites in United States.
Trial summary
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 participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Cell Carcinoma, Small Cell Lung Cancer
- What is being tested?
- XmAb18087 and XmAb18087 ± Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 May 2021to 24 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to provide written informed consent
- Adult participants ≥ 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 participants 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 participants 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
Show all 16Show fewer
- Fertile male participants 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:
- Participants must have progressed on or been ineligible for treatment with anti-PD1 or anti-PDL1 therapy.
- Additional Inclusion Criteria for Part B Cohorts:
- Participants 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
Who cannot join
- Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination with Pembrolizumab
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
City of Hope
Duarte, California, 91010
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Memorial Sloan Kettering
New York, New York, 10065
OU Health, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Swedish Cancer Institute
Seattle, Washington, 98109
University of Washington
Seattle, Washington, 98109
About this study
Official title: A Phase 1b/2 Multiple-Dose Study to Evaluate the Safety and Efficacy of XmAb18087 ± Pembrolizumab in Subjects With Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (DUET-1-02) Protocol
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 participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.
This study was terminated by the sponsor. No participants enrolled in Part B.
- Conditions
- Merkel Cell Carcinoma, Small Cell Lung Cancer
- Being tested
- XmAb18087, XmAb18087 ± Pembrolizumab
- Keywords
- MCC, SCLC
- Medical subject headings
- Carcinoma, Merkel Cell, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb18087Biological
Monoclonal bispecific antibody
XmAb18087 ± PembrolizumabDrug
XmAb18087 ± Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Part A: XmAb18087 Monotherapy | Experimental | Part A, will enroll participants with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort. Receives: Biological: XmAb18087 |
| Part B: XmAb18087 + pembrolizumab | Experimental | Part B, will enroll participants with advanced MCC not previously treated with anti-programmed cell death 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) agents, consists of safety run-in cohorts followed by an expansion cohort. Receives: Drug: XmAb18087 ± Pembrolizumab |
| Part C: XmAb18087 monotherapy | Experimental | Part C will enroll participants with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort. Receives: Biological: XmAb18087 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
A treatment-emergent adverse event (TEAE) was any untoward medical occurrence in a participant treated with study drug. The TEAE does not necessarily have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs may include the onset of new illness and the exacerbation of preexisting conditions. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Measured: Day 1 (after dosing) up to end of study (up to 163 days)
Overall Response Rate as Assessed by RECIST 1.1 Criteria
Measured: Up to end of study (up to 163 days)
Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria
Measured: Up to end of study (up to 163 days)
Secondary outcomes (5)
Duration of Response
Measured: Up to end of study (up to 163 days)
Progression-free Survival as Assessed by Per RECIST 1.1 Criteria
Measured: Up to end of study (up to 163 days)
Overall Survival as Assessed by Per RECIST 1.1 Criteria
Measured: Up to end of study (up to 163 days)
Pharmacokinetics: Maximum Observed Serum Concentration
Measured: Predose up to end of study (up to 163 days)
Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies
Measured: Up to end of study (up to 163 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start10 May 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Why it stopped: The study has been terminated early by the sponsor due to business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Merkel Cell CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Benjamin Thompson, MD, PhD, Study director, Medical Director, Clinical Development, Xencor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590781
- Sponsor's protocol ID
- XmAb18087-02
- Other IDs
- DUET 1-02
- Status last verified
- Mar 2023
- First submitted
- 5 Oct 2020
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Multiple-Dose Study to Evaluate the Safety and Efficacy of XmAb18087 ± Pembrolizumab in Subjects With Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (DUET-1-02) Protocol
- ClinicalTrials.gov ID
- NCT04590781
- Acronym / sponsor ID
- XmAb18087-02
- Conditions
- Merkel Cell Carcinoma, Small Cell Lung Cancer
- Keywords
- MCC, SCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated early by the sponsor due to business decision.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 10 May 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.
This study was terminated by the sponsor. No participants enrolled in Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: XmAb18087 Monotherapy | Experimental | Biological: XmAb18087Part A, will enroll participants with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort. |
| Part B: XmAb18087 + pembrolizumab | Experimental | Drug: XmAb18087 ± PembrolizumabPart B, will enroll participants with advanced MCC not previously treated with anti-programmed cell death 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) agents, consists of safety run-in cohorts followed by an expansion cohort. |
| Part C: XmAb18087 monotherapy | Experimental | Biological: XmAb18087Part C will enroll participants with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to provide written informed consent
- Adult participants ≥ 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 participants must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded [FFPE] block[s] containing tumor that has not been previously irradiated
Key exclusion criteria (3 listed)
- Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination with Pembrolizumab
- 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
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 |
|---|---|---|
| XmAb18087Monoclonal bispecific antibody | Biological | Part A: XmAb18087 Monotherapy, Part C: XmAb18087 monotherapy |
| XmAb18087 ± PembrolizumabXmAb18087 ± Pembrolizumab | Drug | Part B: XmAb18087 + pembrolizumab |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 (after dosing) up to end of study (up to 163 days)
A treatment-emergent adverse event (TEAE) was any untoward medical occurrence in a participant treated with study drug. The TEAE does not necessarily have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs may include the onset of new illness and the exacerbation of preexisting conditions. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Overall Response Rate as Assessed by RECIST 1.1 Criteria
Time frame: Up to end of study (up to 163 days)
Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria
Time frame: Up to end of study (up to 163 days)
5 secondary outcomes
Duration of Response
Time frame: Up to end of study (up to 163 days)
Progression-free Survival as Assessed by Per RECIST 1.1 Criteria
Time frame: Up to end of study (up to 163 days)
Overall Survival as Assessed by Per RECIST 1.1 Criteria
Time frame: Up to end of study (up to 163 days)
Pharmacokinetics: Maximum Observed Serum Concentration
Time frame: Predose up to end of study (up to 163 days)
Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies
Time frame: Up to end of study (up to 163 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Merkel Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Dermatologic Conditions, Healthy Volunteers
Not yet recruitingPhase 1/2
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1
Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer
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.
Benjamin Thompson, MD, PhD study director
Medical Director, Clinical Development, Xencor
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XmAb18087 and XmAb18087 ± Pembrolizumab in people with Merkel Cell Carcinoma and Small Cell Lung Cancer, run by Xencor, Inc. at 7 sites in United States.
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 16 inclusion and 3 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 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Treatment-emergent Adverse Events (time frame: Day 1 (after dosing) up to end of study (up to 163 days)). 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 20 Apr 2023.