Clinical trialPhase 2Completed
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 9 April 2020
- Expected end
- 3 December 2024
- Enrollment
- 25 participants
- Sites
- 1
- Primary outcomes
- Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
- Sponsor
- Other
- Results posted
- 2025-07-29
- Last update
- 29 July 2025
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Brief summary public domain (ClinicalTrials.gov)
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1 [4 months]. Count Of Participants, Participants. INCMGA00012 (PD-1 Antibody) (n=21): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) Using RECIST 1.1. [4 years]. Count Of Participants, Participants. INCMGA00012 (PD-1 Antibody) (n=21): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [34 months]. Median, months (95% Confidence Interval). INCMGA00012 (PD-1 Antibody) (n=22): 1.8 (1.6 to 2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Grade 3 and Higher Study Drug-related Toxicities. [26 months]. Count Of Participants, Participants. Any grade 3 and higher related AE: INCMGA00012 (PD-1 Antibody) (n=22): 3. ALT increased: INCMGA00012 (PD-1 Antibody) (n=22): 2. AST increased: INCMGA00012 (PD-1 Antibody) (n=22): 1. Hypophosphatemia: INCMGA00012 (PD-1 Antibody) (n=22): 1.