INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer

NCT04116073 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: J19106IRB00224849P50CA062924
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.

Conditions

Pancreatic Cancer Non-resectable; Pancreatic Cancer Metastatic

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (3)

• Objective Response Rate (ORR) Using RECIST 1.1.

  4 years

• Progression-free Survival (PFS)

  34 months

• Grade 3 and Higher Study Drug-related Toxicities.

  26 months

Study Arms (1)

INCMGA00012 (PD-1 antibody)

EXPERIMENTAL

All participants received the interventional study drug; INCMGA00012.

Drug: INCMGA00012 (PD-1 antibody)

Interventions

INCMGA00012 (PD-1 antibody) DRUG

INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)

Also known as: MGA012

INCMGA00012 (PD-1 antibody)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Incyte Corporation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Results Point of Contact

• Title: Nilo Azad
• Organization: Sidney Kimmel Comprehensive Center at Johns Hopkins

nilo.azad@jhu.edu

410-614-9169

Study Officials

• Nilofer Azad, MD

  Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: April 9, 2020
• Primary Completion: August 6, 2024
• Study Completion: December 3, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)