Clinical trial · Interventional
INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
NCT04116073CI-TRIAL-00092755completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Metastatic | — | UNRESOLVED | — |
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCMGA00012 (PD-1 antibody) | Drug | Retifanlimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INCMGA00012 (PD-1 antibody)
- description
- All participants received the interventional study drug; INCMGA00012.
- interventionNames
- Drug: INCMGA00012 (PD-1 antibody)
Primary outcomes (1)
- measure
- Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
- timeFrame
- 4 months
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.