NCT03732677 · OUTCOME
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 12 months
What was measured
Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.
Analysis population: The ADA analysis set includes all participants who had non-missing baseline ADA and at least one non-missing post-baseline ADA result.
Groups in this outcome
Durvalumab + Gemcitabine + Cisplatin
Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 453 |
|---|
Reported measurements
ADA positive at any visit (ADA prevalence)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-emergent ADA positive (ADA Incidence)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-boosted ADA
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-induced ADA (Positive Post-baseline only)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA Positive at Baseline only
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA Positive Post-baseline and Positive at Baseline
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Persistently Positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Transiently Positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
nAb Positive at any visit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab + Gemcitabine + Cisplatin | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- ADA positive at any visit (ADA prevalence)
- title
- Treatment-emergent ADA positive (ADA Incidence)
- title
- Treatment-boosted ADA
- title
- Treatment-induced ADA (Positive Post-baseline only)
- title
- ADA Positive at Baseline only
- title
- ADA Positive Post-baseline and Positive at Baseline
- title
- Persistently Positive
- title
- Transiently Positive
- title
- nAb Positive at any visit
- description
- Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.
- groups
- description
- Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- OG000
- title
- Durvalumab + Gemcitabine + Cisplatin
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The ADA analysis set includes all participants who had non-missing baseline ADA and at least one non-missing post-baseline ADA result.
- reporting Status
- POSTED
- time Frame
- Up to 12 months
- title
- Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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