TriangleNCT03599713 · STUDY IN CONTEXT
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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).
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- trial label
- A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0000
- source section id
- NCT03599713-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- up to 26.8 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0001
- source section id
- NCT03599713-om-0001
- source outcome index
- 1
- endpoint
- Duration of Response (DOR)
- endpoint definition
- 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.
- time origin
- up to 55.3 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0002
- source section id
- NCT03599713-om-0002
- source outcome index
- 2
- endpoint
- Disease Control Rate (DCR)
- endpoint definition
- 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.
- time origin
- up to 57.1 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0003
- source section id
- NCT03599713-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- 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).
- time origin
- up to 57.1 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0004
- source section id
- NCT03599713-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival
- endpoint definition
- 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.
- time origin
- up to 60.4 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0005
- source section id
- NCT03599713-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- endpoint definition
- 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.
- time origin
- up to 846 days (up to approximately 2.3 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Evaluable Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Chemotherapy: Naïve
- regimen
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Chemotherapy: Refractory
- regimen
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Chemotherapy: Naïve
- regimen
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Chemotherapy: Refractory
- regimen
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Chemotherapy: Naïve
- regimen
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Chemotherapy: Refractory
- regimen
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Chemotherapy: Naïve
- regimen
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Chemotherapy: Refractory
- regimen
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Chemotherapy: Naïve
- regimen
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Chemotherapy: Refractory
- regimen
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Chemotherapy: Naïve
- regimen
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Chemotherapy: Refractory
- regimen
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03599713-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- harm key
- EG000
- source section id
- NCT03599713-ae
- event group key
- EG000
- event group label
- Chemotherapy: Naïve
- serious affected
- 26
- serious at risk
- 101
- other affected
- 83
- other at risk
- 101
- frequency threshold
- 5
- collection period
- Deaths were assessed for up to 60.4 months. Adverse events were assessed for up to 846 days (up to approximately 2.3 years).
- event definition
- Treatment-emergent adverse events (TEAEs), defined as either AEs reported for the first time or worsening of pre-existing events after the first dose of study drug until 90 days after the last dose of study drug, are reported for members of the Safety Evaluable Population (all enrolled participants who received at least 1 dose of study drug). AEs with onset on/after starting a new anticancer therapy were not summarized as TEAEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- harm key
- EG001
- source section id
- NCT03599713-ae
- event group key
- EG001
- event group label
- Chemotherapy: Refractory
- serious affected
- 2
- serious at risk
- 6
- other affected
- 5
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Deaths were assessed for up to 60.4 months. Adverse events were assessed for up to 846 days (up to approximately 2.3 years).
- event definition
- Treatment-emergent adverse events (TEAEs), defined as either AEs reported for the first time or worsening of pre-existing events after the first dose of study drug until 90 days after the last dose of study drug, are reported for members of the Safety Evaluable Population (all enrolled participants who received at least 1 dose of study drug). AEs with onset on/after starting a new anticancer therapy were not summarized as TEAEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-zynyz-f58ead3f
- nct id
- NCT03599713
- harm key
- EG002
- source section id
- NCT03599713-ae
- event group key
- EG002
- event group label
- Total
- serious affected
- 28
- serious at risk
- 107
- other affected
- 88
- other at risk
- 107
- frequency threshold
- 5
- collection period
- Deaths were assessed for up to 60.4 months. Adverse events were assessed for up to 846 days (up to approximately 2.3 years).
- event definition
- Treatment-emergent adverse events (TEAEs), defined as either AEs reported for the first time or worsening of pre-existing events after the first dose of study drug until 90 days after the last dose of study drug, are reported for members of the Safety Evaluable Population (all enrolled participants who received at least 1 dose of study drug). AEs with onset on/after starting a new anticancer therapy were not summarized as TEAEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice