Trial · NCT04116073
INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
NCT04116073, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2025-07-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer. Trials, record NCT04116073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04116073
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
- NCT number
- NCT04116073
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic
- Interventions
- INCMGA00012 (PD-1 antibody)
- First posted
- 2019-10-04
- Last updated
- 2025-07-29
- Results first posted
- 2025-07-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Rate (DCR) at 4 Months Using RECIST 1.1 | 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. |
| Secondary | Objective Response Rate (ORR) Using RECIST 1.1. | 4 years | 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 |
| Secondary | Progression-free Survival (PFS) | 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. |
| Secondary | Grade 3 and Higher Study Drug-related Toxicities. | 26 months | Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Rate (DCR) at 4 Months Using RECIST 1.1 | 4 months | One subject didnt have a follow up scan after receiving a dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) Using RECIST 1.1. | 4 years | One subject didnt have a follow up scan after receiving a dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | 34 months | months | MEDIAN | |
| SECONDARY | Grade 3 and Higher Study Drug-related Toxicities. | 26 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Rate (DCR) at 4 Months Using RECIST 1.1 | INCMGA00012 (PD-1 Antibody) | 2 | Participants | ||
| Objective Response Rate (ORR) Using RECIST 1.1. | INCMGA00012 (PD-1 Antibody) | 0 | Participants | ||
| Progression-free Survival (PFS) | INCMGA00012 (PD-1 Antibody) | 1.8 | 95% Confidence Interval 1.6 to 2 | months | |
| Grade 3 and Higher Study Drug-related Toxicities. | INCMGA00012 (PD-1 Antibody) | Any grade 3 and higher related AE | 3 | Participants | |
| Grade 3 and Higher Study Drug-related Toxicities. | INCMGA00012 (PD-1 Antibody) | ALT increased | 2 | Participants | |
| Grade 3 and Higher Study Drug-related Toxicities. | INCMGA00012 (PD-1 Antibody) | AST increased | 1 | Participants | |
| Grade 3 and Higher Study Drug-related Toxicities. | INCMGA00012 (PD-1 Antibody) | Hypophosphatemia | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | INCMGA00012 (PD-1 Antibody) | 25 | |
| Overall Study | COMPLETED | INCMGA00012 (PD-1 Antibody) | 22 | |
| Overall Study | NOT COMPLETED | INCMGA00012 (PD-1 Antibody) | 3 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | INCMGA00012 (PD-1 Antibody) | 4 | 25 | 10 |
| other | Hypothyroidism | Endocrine disorders | INCMGA00012 (PD-1 Antibody) | 3 | 25 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | INCMGA00012 (PD-1 Antibody) | 3 | 25 | 3 |
| other | Nausea | Gastrointestinal disorders | INCMGA00012 (PD-1 Antibody) | 2 | 25 | 2 |
| other | Vomiting | Gastrointestinal disorders | INCMGA00012 (PD-1 Antibody) | 2 | 25 | 2 |
| other | Chills | General disorders | INCMGA00012 (PD-1 Antibody) | 2 | 25 | 2 |
| other | Edema Limbs | General disorders | INCMGA00012 (PD-1 Antibody) | 4 | 25 | 4 |
| other | Fatigue | General disorders | INCMGA00012 (PD-1 Antibody) | 8 | 25 | 8 |
| other | Fever | General disorders | INCMGA00012 (PD-1 Antibody) | 3 | 25 | 3 |
| other | Thrush | Infections and infestations | INCMGA00012 (PD-1 Antibody) | 4 | 25 | 4 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INCMGA00012 (PD-1 Antibody) | 17 | 25 |
| Total, other adverse events | INCMGA00012 (PD-1 Antibody) | 21 | 25 |
| Total, serious adverse events | INCMGA00012 (PD-1 Antibody) | 9 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50CA062924 | SPORE in Gastrointestinal Cancers | KLEIN, ALISON P | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04116073
GET https://conductscience.org/api/trials/v1/NCT04116073/events?page=2