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A phase 1/2 trial of Avelumab in penile cancer, run by Transgene, active and no longer recruiting.
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers is a phase 1/2 interventional study registered as NCT03260023 by Transgene, with 143 participants enrolled, started 2017-09-01 and due to reach its primary completion in 2024-09-18. Interventions recorded: TG4001, Avelumab. Conditions listed: HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
143 enrolled.
95% CI 5.64 to 34.72; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication
Source90% CI 2.0 to 4.4; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication · 90% CI 1.7 to 4.2
Source90% CI 1.7 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication · 90% CI 1.4 to 2.8 · 90% CI 1.5 to 5.6 · 90% CI 1.4 to NA · 90% CI 1.4 to 5.6 · 90% CI 2.8 to NA
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1, Overall Response Rateprimary | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 30 | 16.67% | - | - | link |
| Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1primary | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 46 | 3 months | 0.87 | 0.2810 | link |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 44 | 2.8 months | ||||
| Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratificationprimary | Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab | 25 | 4.3 months | - | - | link |
| Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab | 24 | 2.1 months | ||||
| Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab | 14 | 3 months | ||||
| Phase II Part 2 - Cohort A - Anal Cancer - Avelumab | 13 | 3 months | ||||
| Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab | 7 | 1.6 months | ||||
| Phase II Part 2 - Cohort A - Genital Cancer - Avelumab | 7 | 7.2 months |
Shares Avelumab, Immune checkpoint inhibitors.
Shares Node-positive and metastatic penile cancer, Penile cancer.
Shares Avelumab, Immune checkpoint inhibitors.
Shares Avelumab, Immune checkpoint inhibitors.
Shares Avelumab, Immune checkpoint inhibitors.
Shares Avelumab, Immune checkpoint inhibitors.
Shares Avelumab, Immune checkpoint inhibitors.
Shares Avelumab, Immune checkpoint inhibitors.