TriangleNCT04234113 · STUDY IN CONTEXT
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
* Grade (gr) 5 not related to disease progression or other causes * Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue \<5 days; gr ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis * Hy's law cases * Gr 3 AST or ALT or gr 3 bilirubinemia \>5 days * Hematologic DLTs: gr 4 neutropenia or thrombocytopenia \>7 days, febrile neutropenia, gr ≥3 thrombocytopenia with bleeding * Gr 4 immune-related AEs * Gr 3 or 4 non-infectious pneumonitis * Gr 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to gr ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to gr 1 or baseline in 14 days * Gr 2 pneumonitis not downgrading to gr 1 in 3 days * Gr 3 colitis * Part B and Part B1: Recurrent grade 2 pneumonitis
Nanrilkefusp alfa related only
Nanrilkefusp alfa related only
Nanrilkefusp alfa related only
Nanrilkefusp alfa-related deaths only
The following laboratory parameters were assessed: * Coagulation: Prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, fibrinogen * Hematology: Hemoglobin, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, platelet count * Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, lipase * Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, white blood cell count, epithelial cells, bacteria * Thyroid function: TSH, free triiodothyronine (T3), free thyroxine (T4) * Cardiac function: Cardiac troponin T
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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- trial label
- Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
- 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
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 17
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- source section id
- NCT04234113-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Dose-limiting Toxicities (DLTs)
- endpoint definition
- * Grade (gr) 5 not related to disease progression or other causes * Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue \<5 days; gr ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis * Hy's law cases * Gr 3 AST or ALT or gr 3 bilirubinemia \>5 days * Hematologic DLTs: gr 4 neutropenia or thrombocytopenia \>7 days, febrile neutropenia, gr ≥3 thrombocytopenia with bleeding * Gr 4 immune-related AEs * Gr 3 or 4 non-infectious pneumonitis * Gr 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to gr ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to gr 1 or baseline in 14 days * Gr 2 pneumonitis not downgrading to gr 1 in 3 days * Gr 3 colitis * Part B and Part B1: Recurrent grade 2 pneumonitis
- time origin
- Through Cycle 1 (21 days)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0001
- source section id
- NCT04234113-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Adverse Events (AEs)
- endpoint definition
- Nanrilkefusp alfa related only
- time origin
- Day 1 up to approximately 2 years and 2.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients exposed to nanrilkefusp alfa
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0002
- source section id
- NCT04234113-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Serious AEs (SAEs)
- endpoint definition
- Nanrilkefusp alfa related only
- time origin
- Day 1 up to approximately 2 years and 2.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0003
- source section id
- NCT04234113-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa
- endpoint definition
- Nanrilkefusp alfa related only
- time origin
- Day 1 up to approximately 2 years and 2.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients exposed to nanrilkefusp alfa
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0004
- source section id
- NCT04234113-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants Who Died
- endpoint definition
- Nanrilkefusp alfa-related deaths only
- time origin
- Day 1 up to approximately 2 years and 2.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients exposed to nanrilkefusp alfa
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0005
- source section id
- NCT04234113-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function)
- endpoint definition
- The following laboratory parameters were assessed: * Coagulation: Prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, fibrinogen * Hematology: Hemoglobin, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, platelet count * Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, lipase * Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, white blood cell count, epithelial cells, bacteria * Thyroid function: TSH, free triiodothyronine (T3), free thyroxine (T4) * Cardiac function: Cardiac troponin T
- time origin
- Day 1 up to approximately 2 years and 2.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients exposed to nanrilkefusp alfa
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG009
- arm label
- Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG010
- arm label
- Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG010
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- outcome key
- om-0000
- arm key
- OG011
- arm label
- Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg
- regimen
- Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04234113-om-0000#groups/OG011
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG000
- source section id
- NCT04234113-ae
- event group key
- EG000
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG001
- source section id
- NCT04234113-ae
- event group key
- EG001
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG002
- source section id
- NCT04234113-ae
- event group key
- EG002
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG003
- source section id
- NCT04234113-ae
- event group key
- EG003
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG004
- source section id
- NCT04234113-ae
- event group key
- EG004
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG005
- source section id
- NCT04234113-ae
- event group key
- EG005
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg
- serious affected
- 2
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG006
- source section id
- NCT04234113-ae
- event group key
- EG006
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg
- serious affected
- 1
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG007
- source section id
- NCT04234113-ae
- event group key
- EG007
- event group label
- Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg
- serious affected
- 2
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG008
- source section id
- NCT04234113-ae
- event group key
- EG008
- event group label
- Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg
- serious affected
- 3
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG009
- source section id
- NCT04234113-ae
- event group key
- EG009
- event group label
- Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG010
- source section id
- NCT04234113-ae
- event group key
- EG010
- event group label
- Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT04234113
- harm key
- EG011
- source section id
- NCT04234113-ae
- event group key
- EG011
- event group label
- Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
- event definition
- Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
- 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