Metastatic Pancreatic CancerPhase 2NCT04177810
Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
A Phase 2 study testing Cemiplimab and Plerixafor in people with Metastatic Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Cemiplimab and Plerixafor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 19 May 2023
- Phase
- Phase 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
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Have histologically or cytologically-proven ductal pancreatic cancer.
- Have metastatic disease.
- Have documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting.
- Patients with the presence of at least one measurable lesion.
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- Willing to have to a tumor biopsy.
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
- Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
- Men must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Known history or evidence of brain metastases.
- Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
- Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
- Require any antineoplastic therapy.
- Had surgery within 28 days of dosing of investigational agent.
- Has received any prophylactic vaccine within 14 days of first dose of study drug.
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- History of prior treatment with anti-CXCR4.
- Have used any systemic steroids within 14 days of study treatment.
- Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration.
- Hypersensitivity reaction to any monoclonal antibody.
- Evidence of clinical or radiographic ascites.
- Have clinically significant and/or malignant pleural effusion.
- Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has an active known or suspected autoimmune disease.
- Prior tissue or organ allograft or allogeneic bone marrow transplantation.
- All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 5) or baseline before administration of study drug.
- Infection with HIV or hepatitis B or C at screening.
- Patient has a pulse oximetry of <92% on room air.
- Patient is on supplemental home oxygen.
- Has uncontrolled intercurrent acute or chronic medical illness or any use of illicit drugs or substance abuse.
- Patient is unwilling or unable to follow the study schedule for any reason.
- Woman who are pregnant or breastfeeding.
- Have rapidly progressing disease, as judged by the investigator.
- History of significant, recurrent, unexplained postural hypotension in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: A Phase 2 Study of Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
The purpose of this study is to evaluate the safety and clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Cemiplimab, Plerixafor
- Keywords
- Plerixafor, Cemiplimab, Immunotherapy, PD-L1 (receptor blocking antibody), Anti-PD-L1, CXCR4 (chemokine receptor), Antibodies, Metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN-2810, LIBTAYO
Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years.
PlerixaforDrug
Also called AMD3100, MOZOBIL
Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab and Plerixafor | Experimental | All participants will receive Cemiplimab and Plerixafor. Receives: Drug: Cemiplimab; Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: 10 months
Secondary outcomes (2)
Overall Response Rate (ORR) Using RECIST 1.1 Criteria
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.
Measured: 10 months
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities
Defined using NCI CTCAE v5.0
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start16 Nov 2020
- Primary completion29 Mar 2023
- Study completion19 May 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, American Association for Cancer Research, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dung Le, MD, Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177810
- Sponsor's protocol ID
- J19113
- Other IDs
- IRB00225153, 5P01CA247886
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2019
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma Q, He H, Liu T, Li Y, Mao C, Shi C, Yao Q. A MYC-LDHA-MCT4 expression program marks an SPP1/TREM2-centered macrophage state in pancreatic ductal adenocarcinoma. Front Immunol. 2026 Oct 5;17:1978427. doi: 10.3389/fimmu.2026.1978427. eCollection 2026.
PubMed 42898383
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04177810
- Acronym / sponsor ID
- J19113
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Plerixafor, Cemiplimab, Immunotherapy, PD-L1 (receptor blocking antibody), Anti-PD-L1, CXCR4 (chemokine receptor), Antibodies, Metastatic pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, American Association for Cancer Research, National Cancer Institute (NCI)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 20 Feb 2024
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 clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab and Plerixafor | Experimental | Drug: Cemiplimab, Drug: PlerixaforAll participants will receive Cemiplimab and Plerixafor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Have histologically or cytologically-proven ductal pancreatic cancer.
- Have metastatic disease.
- Have documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting.
Key exclusion criteria (24 listed)
- Known history or evidence of brain metastases.
- Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
- Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
- Require any antineoplastic therapy.
- Had surgery within 28 days of dosing of investigational agent.
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 |
|---|---|---|
| CemiplimabAlso: REGN-2810, LIBTAYOCemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. | Drug | Cemiplimab and Plerixafor |
| PlerixaforAlso: AMD3100, MOZOBILPlerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years. | Drug | Cemiplimab and Plerixafor |
Primary outcome
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
Time frame: 10 months
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
2 secondary outcomes
Overall Response Rate (ORR) Using RECIST 1.1 Criteria
Time frame: 10 months
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities
Time frame: 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42898383Ma Q, He H, Liu T, Li Y, Mao C, Shi C, Yao Q. A MYC-LDHA-MCT4 expression program marks an SPP1/TREM2-centered macrophage state in pancreatic ductal adenocarcinoma. Front Immunol. 2026 Oct 5;17:1978427. doi: 10.3389/fimmu.2026.1978427. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Dung Le, MD principal investigator
Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab and Plerixafor in people with Metastatic Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 12 inclusion and 24 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: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Feb 2024). 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?
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria (time frame: 10 months). 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 NCT04177810, which also lists 1 linked publication.
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 23 Feb 2024.