Trial · NCT03599713
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
NCT03599713, Phase 2, Completed, Incyte Corporation; results first posted 2023-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201). Trials, record NCT03599713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03599713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
- NCT number
- NCT03599713
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Metastatic Merkel Cell Carcinoma
- Interventions
- Retifanlimab
- First posted
- 2018-07-26
- Last updated
- 2025-08-05
- Other registries' IDs
- eudract:2018-001627-39
- Results first posted
- 2023-05-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | up to 26.8 months | ORR was defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by Independent Central Radiographic Review (ICR), at any post-Baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
| Secondary | Duration of Response (DOR) | up to 55.3 months | DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until PD, or death due to any cause, as determined by ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. A Kaplan-Meier estimate (estimated median) of the distribution function is reported. |
| Secondary | Disease Control Rate (DCR) | up to 57.1 months | DCR was defined as the percentage of participants with a confirmed overall response (CR and PR) or stable disease (SD) (non-CR/non-PD) lasting at least 6 months from the start of treatment, until the first PD or new anti-cancer therapy, per RECIST v1.1 as determined by ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. |
| Secondary | Progression-free Survival (PFS) | up to 57.1 months | According to RESIST v1.1, PFS was defined the time from the start of therapy until disease progression, or death due to any cause, as determined by ICR. Evaluation of target lesions: PD: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions: PD: Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered PD). |
| Secondary | Overall Survival | up to 60.4 months | Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 846 days (up to approximately 2.3 years) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE. |
| Secondary | First-dose Cmax of Retifanlimab | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 | Cmax was defined as the maximum observed plasma concentration. |
| Secondary | First-dose Cmin of Retifanlimab | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 | Cmin was defined as the minimum observed plasma concentration over the dose interval. |
| Secondary | First-dose AUC0-t of Retifanlimab | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 | AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t. |
Source ClinicalTrials.gov
Outcomes9
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) | up to 26.8 months | Full Analysis Set (FAS): all participants enrolled in the study who received at least 1 dose of study drug as of 15 October 2020 (selected to allow for at least 60 chemotherapy-naïve participants to be followed for at least 6 months after first response assessment). Analysis was based on the chemotherapy-naïve subset of the FAS. Confidence intervals (CIs) were calculated based on the exact method for binomial distributions. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | up to 55.3 months | Safety Evaluable Population: all enrolled participants who received at least 1 dose of study drug. Analysis was based on the chemotherapy-naïve subset of the population. Only those participants who had confirmed CR or PR prior to PD or start of new anticancer therapy were assessed. The 95% CI was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation. | months | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | up to 57.1 months | Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. CIs were calculated based on the exact method for binomial distributions. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | up to 57.1 months | Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median PFS time was estimated using the Kaplan-Meier method. The CI for median PFS time was calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Overall Survival | up to 60.4 months | Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median overall survival time was estimated using the Kaplan-Meier method. CI for median overall survival time was calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 846 days (up to approximately 2.3 years) | Safety Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | First-dose Cmax of Retifanlimab | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 | Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and have provided a Baseline and at least 1 post-dose PK sample | micrograms per milliliter (μg/mL) | MEAN |
| SECONDARY | First-dose Cmin of Retifanlimab | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 | PK Evaluable Population | μg/mL | MEAN |
| SECONDARY | First-dose AUC0-t of Retifanlimab | preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1 | PK Evaluable Population | day*mg/L | MEAN |
Source ClinicalTrials.gov
Results by group10
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) | Chemotherapy: Naïve | 52.3 | 95% Confidence Interval 39.5 to 64.9 | percentage of participants | |
| Duration of Response (DOR) | Chemotherapy: Naïve | NA | 95% Confidence Interval 22.87 to NA | months | |
| Disease Control Rate (DCR) | Chemotherapy: Naïve | 60.4 | 95% Confidence Interval 50.2 to 70.0 | percentage of participants | |
| Progression-free Survival (PFS) | Chemotherapy: Naïve | 16.03 | 95% Confidence Interval 9.03 to 32.23 | months | |
| Overall Survival | Chemotherapy: Naïve | NA | 95% Confidence Interval 45.24 to NA | months | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Chemotherapy: Naïve | 92 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Chemotherapy: Refractory | 5 | Participants | ||
| First-dose Cmax of Retifanlimab | All Participants | 144 | Standard Deviation 32.6 | micrograms per milliliter (μg/mL) | |
| First-dose Cmin of Retifanlimab | All Participants | 20.5 | Standard Deviation 7.23 | μg/mL | |
| First-dose AUC0-t of Retifanlimab | All Participants | 1770 | Standard Deviation 549 | day*mg/L |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy: Naïve | 101 | |
| Overall Study | STARTED | Chemotherapy: Refractory | 6 | |
| Overall Study | Safety Evaluable Population | Chemotherapy: Naïve | 101 | |
| Overall Study | Safety Evaluable Population | Chemotherapy: Refractory | 6 | |
| Overall Study | Enrolled Population | Chemotherapy: Naïve | 101 | |
| Overall Study | Enrolled Population | Chemotherapy: Refractory | 6 | |
| Overall Study | Full Analysis Set | Chemotherapy: Naïve | 65 | |
| Overall Study | Full Analysis Set | Chemotherapy: Refractory | 6 | |
| Overall Study | COMPLETED | Chemotherapy: Naïve | 0 | |
| Overall Study | COMPLETED | Chemotherapy: Refractory | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events279
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 | Alanine aminotransferase increased | Investigations | Chemotherapy: Naïve | 8 | 101 | 8 |
| other | Alanine aminotransferase increased | Investigations | Chemotherapy: Refractory | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Total | 8 | 107 | 8 |
| other | Amylase increased | Investigations | Chemotherapy: Naïve | 8 | 101 | 11 |
| other | Amylase increased | Investigations | Chemotherapy: Refractory | 0 | 6 | 0 |
| other | Amylase increased | Investigations | Total | 8 | 107 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy: Naïve | 6 | 101 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy: Refractory | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 7 | 107 | 7 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Chemotherapy: Naïve | 17 | 101 | 23 |
1 to 10 of 279Source ClinicalTrials.gov
See all 279 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy: Naïve | 39 | 101 |
| Total, all-cause mortality | Chemotherapy: Refractory | 3 | 6 |
| Total, all-cause mortality | Total | 42 | 107 |
| Total, other adverse events | Chemotherapy: Naïve | 83 | 101 |
| Total, other adverse events | Chemotherapy: Refractory | 5 | 6 |
| Total, other adverse events | Total | 88 | 107 |
| Total, serious adverse events | Chemotherapy: Naïve | 26 | 101 |
| Total, serious adverse events | Chemotherapy: Refractory | 2 | 6 |
| Total, serious adverse events | Total | 28 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40796223 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Chemotherapy: Naïve vs Chemotherapy: Refractory: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
Source Trial comparisons
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/NCT03599713
GET https://conductscience.org/api/trials/v1/NCT03599713/events?page=2