Trial · NCT03260023
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 60
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies | Phase I - TG4001 5x10e6 Pfu + Avelumab | 0 | DLT | ||
| Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies | Phase I - TG4001 5x10e7 Pfu + Avelumab | 0 | DLT | ||
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | Overall Response Rate | 16.67 | 95% Confidence Interval 5.64 to 34.72 | percentage of participants |
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | Disease Control Rate (DCR) | 46.67 | 95% Confidence Interval 28.34 to 65.67 | percentage of participants |
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | Complete Response (CR) | 3.33 | 95% Confidence Interval 0.08 to 17.22 | percentage of participants |
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | Partial Response (PR) | 13.33 | 95% Confidence Interval 3.76 to 30.72 | percentage of participants |
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | Stable Disease (SD) | 30.0 | 95% Confidence Interval 14.73 to 49.40 | percentage of participants |
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | Progressive disease (PD) | 53.33 | 95% Confidence Interval 34.33 to 71.66 | percentage of participants |
| Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1 | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 3.0 | 90% Confidence Interval 2.0 to 4.4 | Months | |
| Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1 | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 2.8 | 90% Confidence Interval 1.7 to 4.2 | Months | |
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab | 4.3 | 90% Confidence Interval 1.7 to 12.7 | Months | |
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab | 2.1 | 90% Confidence Interval 1.4 to 2.8 | Months | |
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab | 3.0 | 90% Confidence Interval 1.5 to 5.6 | Months | |
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | Phase II Part 2 - Cohort A - Anal Cancer - Avelumab | 3.0 | 90% Confidence Interval 1.4 to NA | Months | |
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab | 1.6 | 90% Confidence Interval 1.4 to 5.6 | Months | |
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | Phase II Part 2 - Cohort A - Genital Cancer - Avelumab | 7.2 | 90% Confidence Interval 2.8 to NA | Months | |
| Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A | Phase I - TG4001 5x10e6 Pfu + Avelumab | Overall Response Rate (ORR) | 0.0 | percentage of participants | |
| Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A | Phase I - TG4001 5x10e7 Pfu + Avelumab | Overall Response Rate (ORR) | 50.0 | percentage of participants | |
| Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | Overall Response Rate (ORR) | 15.2 | percentage of participants | |
| Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | Overall Response Rate (ORR) | 13.6 | percentage of participants |
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.
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