Trial Outcomes & Findings for INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer (NCT NCT04116073)

Last Updated: 2025-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

4 months

Results posted on

2025-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	INCMGA00012 (PD-1 Antibody) All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	INCMGA00012 (PD-1 Antibody) All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Overall Study Withdrawal by Subject	2
Overall Study failed to maintained eligibility	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INCMGA00012 (PD-1 Antibody) n=22 Participants All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=39 Participants
Age, Categorical >=65 years	17 Participants n=39 Participants
Sex: Female, Male Female	10 Participants n=39 Participants
Sex: Female, Male Male	12 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	3 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	18 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Region of Enrollment United States	22 Participants n=39 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0	6 Participants n=39 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1	16 Participants n=39 Participants

PRIMARY outcome

Timeframe: 4 months

Population: One subject didnt have a follow up scan after receiving a dose of the study drug.

Outcome measures

Outcome measures
Measure	INCMGA00012 (PD-1 Antibody) n=21 Participants All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1	2 Participants

SECONDARY outcome

Timeframe: 4 years

Population: One subject didnt have a follow up scan after receiving a dose of the study drug.

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

Outcome measures

Outcome measures
Measure	INCMGA00012 (PD-1 Antibody) n=21 Participants All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Objective Response Rate (ORR) Using RECIST 1.1.	0 Participants

SECONDARY outcome

Timeframe: 34 months

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.

Outcome measures

Outcome measures
Measure	INCMGA00012 (PD-1 Antibody) n=22 Participants All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Progression-free Survival (PFS)	1.8 months Interval 1.6 to 2.0

SECONDARY outcome

Timeframe: 26 months

Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.

Outcome measures

Outcome measures
Measure	INCMGA00012 (PD-1 Antibody) n=22 Participants All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Grade 3 and Higher Study Drug-related Toxicities. Any grade 3 and higher related AE	3 Participants
Grade 3 and Higher Study Drug-related Toxicities. ALT increased	2 Participants
Grade 3 and Higher Study Drug-related Toxicities. AST increased	1 Participants
Grade 3 and Higher Study Drug-related Toxicities. Hypophosphatemia	1 Participants

Adverse Events

INCMGA00012 (PD-1 Antibody)

Serious events: 9 serious events

Other events: 21 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	INCMGA00012 (PD-1 Antibody) n=25 participants at risk All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Investigations Alanine Aminotransferase Increased	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Investigations Aspartate Aminotransferase Increased	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Cardiac disorders Atrial Fibrillation	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Hepatobiliary disorders Bile Duct Stenosis	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Cardiac disorders Cardiac Arrest	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
General disorders Disease Progression	20.0% 5/25 • Number of events 5 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Infections and infestations Lung Infection	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Infections and infestations Sepsis	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Gastrointestinal disorders Small Intestinal Obstruction	4.0% 1/25 • Number of events 1 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.

Other adverse events

Other adverse events
Measure	INCMGA00012 (PD-1 Antibody) n=25 participants at risk All participants received the interventional study drug; INCMGA00012. INCMGA00012 (PD-1 antibody): 500 mg, 30 min IV infusion on Day 1 of each cycle (every 28 days)
Blood and lymphatic system disorders Anemia	16.0% 4/25 • Number of events 10 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Endocrine disorders Hypothyroidism	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Gastrointestinal disorders Abdominal Pain	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
General disorders Chills	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
General disorders Edema Limbs	16.0% 4/25 • Number of events 4 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
General disorders Fatigue	32.0% 8/25 • Number of events 8 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
General disorders Fever	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Infections and infestations Thrush	16.0% 4/25 • Number of events 4 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Infections and infestations Urinary Tract Infection	8.0% 2/25 • Number of events 4 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Injury, poisoning and procedural complications Bruising	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Injury, poisoning and procedural complications Fall	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Investigations Alanine Aminotransferase Increased	8.0% 2/25 • Number of events 6 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Investigations Alkaline Phosphatase Increased	12.0% 3/25 • Number of events 4 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Injury, poisoning and procedural complications Aspartate Aminotransferase Increased	12.0% 3/25 • Number of events 5 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Injury, poisoning and procedural complications Lymphocyte Count Decreased	8.0% 2/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Investigations Weight Gain	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Investigations Weight Loss	32.0% 8/25 • Number of events 11 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Metabolism and nutrition disorders Anorexia	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Metabolism and nutrition disorders Hypoalbuminemia	8.0% 2/25 • Number of events 4 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Metabolism and nutrition disorders Hypokalemia	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 3/25 • Number of events 3 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Musculoskeletal and connective tissue disorders Flank pain	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Nervous system disorders Headache	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Skin and subcutaneous tissue disorders Dry skin	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Skin and subcutaneous tissue disorders Pruritus	12.0% 3/25 • Number of events 4 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Skin and subcutaneous tissue disorders Rash Acneiform	8.0% 2/25 • Number of events 2 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.
Vascular disorders Thromboembolic Event	20.0% 5/25 • Number of events 5 • Adverse events were collected for up to 26 months. Subjects were followed for survival for up 56 months.

Additional Information

Nilo Azad

Sidney Kimmel Comprehensive Center at Johns Hopkins

Phone: 410-614-9169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place