Trial · NCT03533283
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Objective Response Rate (ORR) as Measured by Independent Review Committee (IRC) | Baseline until the end of treatment (13 to 14 months), then ever 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Primary | Dose Limiting Toxicities (DLTs) | Atezolizumab Arm: During DLT period of 21 days (or up to 42 days in the case of cycle delay), starting on Day 1, Cycle 2; Polatuzumab Vedotin Arm: During 5-week DLT period starting Cycle 1, Day 8 | |
| Secondary | Best ORR as Measured by Investigator | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Best Complete Response (CR) Rate, as Assessed by Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT) Scan | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Duration of Complete Response (DOCR) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Duration of Response (DOR) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Progression-Free Survival (PFS) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Event-Free Survival (EFS) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Time to First Complete Response (TFCR) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Time to First Overall Response (TFOR) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Overall Survival (OS) | Baseline through end of survival follow-up phase (survival follow-up is every 3 months until death, lost to follow-up, withdrawal of consent, or study termination) | |
| Secondary | Percentage of Participants with Adverse Events (AEs) | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Incidence and Severity of Cytokine Release Syndrome (CRS) Following Glofitamab Administration | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Anti-Drug Antibody (ADA) Formation | Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) | |
| Secondary | Elimination Half-Life (T1/2) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin | At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression) | |
| Secondary | Area Under the Concentration-Time Curve (AUC) for Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin | At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression) | |
| Secondary | Time to Maximum Observed Serum Concentration (Tmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin | At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression) | |
| Secondary | Maximum Observed Serum Concentration (Cmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin | At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression) | |
| Secondary | Minimum Serum Concentration (Cmin) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin | At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression) | |
| Secondary | Clearance (CL) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin | At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03533283/registered