Pancreatic Cancer Non-resectablePhase 2NCT04116073
INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
A Phase 2 study testing INCMGA00012 (PD-1 antibody) in people with Pancreatic Cancer Non-resectable and Pancreatic Cancer Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic
- What is being tested?
- INCMGA00012 (PD-1 antibody)
- 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
- 9 Apr 2020to 3 Dec 2024
- 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.
- Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas or ampulla.
- Has unresectable or metastatic measurable disease.
- Has received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments.
- Presence of at least one lesion with measurable disease.
- Accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- If HIV-positive, then all of the following criteria must also be met: cluster of differentiation (CD) 4+ count ≥ 350/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
- 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.
- Has had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study drug.
- Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- Expected to require any other form of systemic or localized antineoplastic therapy while on study.
- Has had major surgery within 28 days of dosing of investigational agent, excluding minor procedures.
- Has received a live vaccine within 28 days prior to the first dose of study drug.
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- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, anti-OX40 and LAG-3 antibodies)
- Have used any systemic steroids within 14 days of study treatment.
- Hypersensitivity reaction to any monoclonal antibody.
- Evidence of clinical or radiographic ascites.
- Have clinically significant and/or malignant pleural effusion.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of autoimmune disease requiring systemic immunosuppression within the last 2 years.
- Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded.
- All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to a grade 1 or baseline before administration of study drug.
- Infection with Hepatitis A, B or C.
- Patient has a pulse oximetry of <92% on room air.
- Patient is on supplemental home oxygen.
- Has an unhealed surgical wound or ulcer, or a bone fracture considered non-healing.
- Patient has clinically significant heart disease.
- Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse.
- Unwilling or unable to follow the study schedule for any reason.
- Patient has history of non-infectious pneumonitis.
- Serum albumin level less than 2.8 g/dL.
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 II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
- Being tested
- INCMGA00012 (PD-1 antibody)
- Keywords
- Antibody, Anti-PD-1, Human monoclonal immunoglobulin antibody, Immunotherapy, INCMGA00012 (anti-PD-1 antibody), Anti-PD-1 antibody (MGA012), Metastatic adenosquamous pancreatic cancer, Unresectable adenosquamous pancreatic cancer, Adenosquamous pancreatic cancer, Programmed cell death protein 1 (PD-1), Programmed death-ligand 1 (PD-L1)
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCMGA00012 (PD-1 antibody)Drug
Also called MGA012
INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
| Study group | Role | What they receive |
|---|---|---|
| INCMGA00012 (PD-1 antibody) | Experimental | All participants received the interventional study drug; INCMGA00012. Receives: Drug: INCMGA00012 (PD-1 antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
Disease control rate (DCR) is defined as the proportion of subjects with complete response, partial response and stable disease based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Subjects who discontinue due to toxicity prior to post-baseline tumor assessments will be evaluable and considered treatment failures.
Measured: 4 months
Secondary outcomes (3)
Objective Response Rate (ORR) Using RECIST 1.1.
ORR is defined as the proportion subjects with partial response (PR) or complete response (CR) according to RECIST 1.1. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders
Measured: 4 years
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the number of months from the first dose of retifanlimab to radiographic disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria), documented clinical progression as assessed by the treating provider, or death due to any cause. PFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis.
Measured: 34 months
Grade 3 and Higher Study Drug-related Toxicities.
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start9 Apr 2020
- Primary completion6 Aug 2024
- Study completion3 Dec 2024
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 Pancreatic Cancer Non-resectableStudies 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
- Incyte Corporation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nilofer Azad, MD, Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116073
- Sponsor's protocol ID
- J19106
- Other IDs
- IRB00224849, P50CA062924
- Status last verified
- Jul 2025
- First submitted
- 3 Oct 2019
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
- ClinicalTrials.gov ID
- NCT04116073
- Acronym / sponsor ID
- J19106
- Keywords
- Antibody, Anti-PD-1, Human monoclonal immunoglobulin antibody, Immunotherapy, INCMGA00012 (anti-PD-1 antibody), Anti-PD-1 antibody (MGA012), Metastatic adenosquamous pancreatic cancer, Unresectable adenosquamous 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
- Incyte Corporation, National Cancer Institute (NCI)
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCMGA00012 (PD-1 antibody) | Experimental | Drug: INCMGA00012 (PD-1 antibody)All participants received the interventional study drug; INCMGA00012. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years.
- Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas or ampulla.
- Has unresectable or metastatic measurable disease.
- Has received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments.
- Presence of at least one lesion with measurable disease.
Key exclusion criteria (24 listed)
- Known history or evidence of brain metastases.
- Has had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study drug.
- Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- Expected to require any other form of systemic or localized antineoplastic therapy while on study.
- Has had major surgery within 28 days of dosing of investigational agent, excluding minor procedures.
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 |
|---|---|---|
| INCMGA00012 (PD-1 antibody)Also: MGA012INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days) | Drug | INCMGA00012 (PD-1 antibody) |
Primary outcome
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
Time frame: 4 months
Disease control rate (DCR) is defined as the proportion of subjects with complete response, partial response and stable disease based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Subjects who discontinue due to toxicity prior to post-baseline tumor assessments will be evaluable and considered treatment failures.
3 secondary outcomes
Objective Response Rate (ORR) Using RECIST 1.1.
Time frame: 4 years
Progression-free Survival (PFS)
Time frame: 34 months
Grade 3 and Higher Study Drug-related Toxicities.
Time frame: 26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nilofer Azad, 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 INCMGA00012 (PD-1 antibody) in people with Pancreatic Cancer Non-resectable and Pancreatic Cancer Metastatic, 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 13 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 29 Jul 2025. 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 29 Jul 2025). 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?
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1 (time frame: 4 months). 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 29 Jul 2025.