Trial · NCT04231981
Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)
NCT04231981, Phase 2, Completed, MedSIR; results first posted 2025-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS). Trials, record NCT04231981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04231981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)
- NCT number
- NCT04231981
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- MedSIR
- Conditions
- Penile Cancer
- Interventions
- Retifanlimab
- First posted
- 2020-01-18
- Last updated
- 2025-05-29
- Other registries' IDs
- eudract:2019-001172-11
- Results first posted
- 2025-05-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1. |
| Secondary | Efficacy Determined by Clinical Benefit Rate (CBR) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | CBR is defined as the number of patients with CR, partial response (PR) or stable disease (SD) (for at least 12 weeks) divided by the number of patients in the analysis set. |
| Secondary | Efficacy Determined by Progression-free Survival (PFS) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1. |
| Secondary | Efficacy Determined by 6-months PFS | Baseline up to 6 months | 6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria. |
| Secondary | Efficacy Determined by Duration of Response (DoR) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | DoR is defined as the time from first documented CR or PR until disease progression or death from any cause, based on local investigator's assessment according to RECIST criteria v1.1. |
| Secondary | Efficacy Determined by Overall Survival (OS) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | OS is defined as the time from the date of first dose of study treatment until death by any cause or the last date the patient was known to be alive. |
| Secondary | Efficacy Determined by Maximum Tumor Shrinkage | From baseline until disease progression or treatment discontinuation, up to 10.3 months | Maximum tumor shrinkage is defined as the percentage of tumor shrinkage from baseline (obtained from the sum of largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria v1.1. |
| Secondary | Safety Adverse Events (AEs) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events \[SAEs\]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Efficacy Determined by Clinical Benefit Rate (CBR) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Efficacy Determined by Progression-free Survival (PFS) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | months | MEDIAN | |
| SECONDARY | Efficacy Determined by 6-months PFS | Baseline up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Efficacy Determined by Duration of Response (DoR) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | months | MEDIAN | |
| SECONDARY | Efficacy Determined by Overall Survival (OS) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Efficacy Determined by Maximum Tumor Shrinkage | From baseline until disease progression or treatment discontinuation, up to 10.3 months | percentage of change from baseline | MEAN | |
| SECONDARY | Safety Adverse Events (AEs) | From baseline until disease progression or treatment discontinuation, up to 10.3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Interventional Arm | Yes | 3 | Participants | |
| Objective Response Rate (ORR) | Interventional Arm | No | 15 | Participants | |
| Efficacy Determined by Clinical Benefit Rate (CBR) | Interventional Arm | Yes | 4 | Participants | |
| Efficacy Determined by Clinical Benefit Rate (CBR) | Interventional Arm | No | 14 | Participants | |
| Efficacy Determined by Progression-free Survival (PFS) | Interventional Arm | 2 | 95% Confidence Interval 1.6 to 3.3 | months | |
| Efficacy Determined by 6-months PFS | Interventional Arm | 2 | Participants | ||
| Efficacy Determined by Duration of Response (DoR) | Interventional Arm | 3.3 | Full Range 1.8 to 8.5 | months | |
| Efficacy Determined by Overall Survival (OS) | Interventional Arm | 17 | Participants | ||
| Efficacy Determined by Maximum Tumor Shrinkage | Interventional Arm | 15.9 | Standard Deviation 49.1 | percentage of change from baseline | |
| Safety Adverse Events (AEs) | Interventional Arm | Related AEs | 5 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Interventional Arm | 18 | |
| Overall Study | COMPLETED | Interventional Arm | 0 | |
| Overall Study | NOT COMPLETED | Interventional Arm | 18 |
Source ClinicalTrials.gov
Adverse events19
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 | Transaminases increased | Investigations | Interventional Arm | 1 | 18 | 2 |
| other | Fatigue | General disorders | Interventional Arm | 4 | 18 | 8 |
| other | Xerosis | General disorders | Interventional Arm | 1 | 18 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Interventional Arm | 1 | 18 | 1 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Interventional Arm | 1 | 18 | 1 |
| other | Skin oedema | Skin and subcutaneous tissue disorders | Interventional Arm | 1 | 18 | 1 |
| other | Dysuria | Renal and urinary disorders | Interventional Arm | 1 | 18 | 1 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Interventional Arm | 1 | 18 | 1 |
| other | Decreased appetite | Metabolism and nutrition disorders | Interventional Arm | 1 | 18 | 2 |
| serious | Cellulitis | Infections and infestations | Interventional Arm | 1 | 18 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interventional Arm | 16 | 18 |
| Total, other adverse events | Interventional Arm | 5 | 18 |
| Total, serious adverse events | Interventional Arm | 5 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT04231981
GET https://conductscience.org/api/trials/v1/NCT04231981/registered