18 and older, any sex, with Metastatic Non-small Cell Lung Cancer or Locally Advanced Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· up to 25.9 months
ORR was defined as the percentage of participants with a best 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 the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. 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% decre
Group
Value
95% CI
Melanoma
40.0
23.9 – 57.9
Non-small Cell Lung Cancer
34.8
16.4 – 57.3
Urethelial Carcinoma
37.9
20.7 – 57.7
Renal Cell Carcinoma
23.5
10.7 – 41.2
Duration of Response (DOR)Secondary· up to 24.0 months
DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. 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 prog
Group
Value
95% CI
Melanoma
NA
9.2 – NA
Non-small Cell Lung Cancer
18.2
1.9 – NA
Urethelial Carcinoma
11.5
2.2 – NA
Renal Cell Carcinoma
NA
2.8 – NA
Disease Control Rate (DCR)Secondary· up to 25.9 months
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. 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 presenc
Group
Value
95% CI
Melanoma
54.3
36.6 – 71.2
Non-small Cell Lung Cancer
65.2
42.7 – 83.6
Urethelial Carcinoma
55.2
35.7 – 73.6
Renal Cell Carcinoma
64.7
46.5 – 80.3
Progression-free Survival (PFS)Secondary· up to 25.9 months
According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.
Group
Value
95% CI
Melanoma
3.6
1.8 – NA
Non-small Cell Lung Cancer
4.4
1.8 – 21.9
Urethelial Carcinoma
5.7
1.8 – 13.6
Renal Cell Carcinoma
5.4
2.3 – 11.4
Overall SurvivalSecondary· up to 28.2 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.
Group
Value
95% CI
Melanoma
NA
8.7 – NA
Non-small Cell Lung Cancer
21.9
5.2 – NA
Urethelial Carcinoma
15.2
7.7 – NA
Renal Cell Carcinoma
NA
NA – NA
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Secondary· up to approximately 2.3 years
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer thera
Group
Value
95% CI
Melanoma
32
Non-small Cell Lung Cancer
21
Urethelial Carcinoma
28
Renal Cell Carcinoma
32
First-dose Cmax of RetifanlimabSecondary· preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
Group
Value
95% CI
All Participants
143
± 30.9
Cmax of Retifanlimab at Steady-stateSecondary· preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
Group
Value
95% CI
All Participants
181
± 39.4
First-dose Tmax of RetifanlimabSecondary· preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
tmax was defined as the time to the maximum concentration of retifanlimab.
Group
Value
95% CI
All Participants
0.500
0.500 – 1.00
Tmax of Retifanlimab at Steady-stateSecondary· preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
tmax was defined as the time to the maximum concentration of retifanlimab.
Group
Value
95% CI
All Participants
0.500
0.500 – 1.00
First-dose Cmin of RetifanlimabSecondary· preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
Group
Value
95% CI
All Participants
18.0
± 7.52
Cmin of Retifanlimabv at Steady-stateSecondary· preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
Group
Value
95% CI
All Participants
38.2
± 16.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07468136 — Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas
· Phase 1, PHASE2
· not yet recruiting
NCT06896188 — 9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLE
· Phase 1
· recruiting
NCT06959537 — A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifan
· Phase 1
· recruiting
NCT06939036 — Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
· Phase 1, PHASE2
· terminated
NCT06873789 — A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
· Phase 1, PHASE2
· active not recruiting
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Other Incyte Corporation trials
Trials by the same sponsor.
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· Phase 2
· recruiting
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· Phase 1
· recruiting
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· Phase 3
· recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A
· Phase 1
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· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 21 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03679767.