Trial · NCT03260023
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
NCT03260023, Phase 1, Phase 2, Active not recruiting, Transgene; results first posted 2025-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers. Trials, record NCT03260023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03260023
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
- NCT number
- NCT03260023
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 143 participants, actual
- Lead sponsor
- Transgene
- Conditions
- HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma
- Interventions
- TG4001, Avelumab
- First posted
- 2017-08-24
- Last updated
- 2026-02-05
- Results first posted
- 2025-12-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | From Day 1 to Day 28 | Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks |
| Primary | Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years. | Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. |
| Primary | Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1 | From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year. | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy. |
| Primary | Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year. | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy. |
| Secondary | Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A | From treatment start (phase Ib) / randomization (phase II part 2) : Every 6 weeks for the first 9 months, then every 12 weeks up to 2 years. | Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. |
| Secondary | Progression Free Survival (PFS) (Phase Ib, Phase II Part 1) | From treatment start (phase Ib, phase II part 1): Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year. | PFS is defined as the time from the date of first study treatment administration (Phase Ib, Phase II Part1) to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy. |
| Secondary | Overall Survival (OS) : Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A | From treatment start : Phase Ib, Phase II part 1 / from randomization: Phase II part 2 Cohort A through study completion, for an average of 4.5 years. | Time from the date of first study treatment administration Phase Ib, Phase II part 1 or time from the date of randomization Phase II part 2 Cohort A to the date of death due to any cause. If a patient is not known to have died survival will be censored at the date of last contact. |
| Secondary | Duration of Overall Response (DoR): Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A | From treatment start Phase Ib, Phase II part 1 / from randomization Phase II part 2 Cohort A : every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 2.5 years. | Duration of overall response in weeks (DoR) applies only to patients whose best overall response is CR or PR. The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as first documented disease progression or death due to underlying cancer. |
| Secondary | Proportion of Progressive Disease Phase II Part 2 Cohort B | From randomization: every 6 weeks up to 24 weeks. | Number of participants with liver metastases at baseline who has a documented disease progression as per RECIST1.1. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | From Day 1 to Day 28 | Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF.~Phase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint.~Therefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary endpoint. | DLT | NUMBER |
| PRIMARY | Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1 | From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years. | Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease.~Phase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint.~Therefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint. | percentage of participants | NUMBER |
| PRIMARY | Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1 | From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year. | Phase II part 2, Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS)~For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint. | Months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification | From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year. | Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS)~For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint.~Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A | From treatment start (phase Ib) / randomization (phase II part 2) : Every 6 weeks for the first 9 months, then every 12 weeks up to 2 years. | For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation.~Phase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint.~Therefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR as secondary endpoint. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) (Phase Ib, Phase II Part 1) | From treatment start (phase Ib, phase II part 1): Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year. | For Phase Ib: All participants included and who received any amount of study treatment.~For phase II part 1: Evaluable participants population (EPP)~Phase II part 2, cohort A and cohort B : the outcome measure PFS has not been defined as secondary endpoint.~Therefore Phase II part 2, cohort A and cohort B are not included in the analysis population for PFS as secondary endpoint. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) : Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A | From treatment start : Phase Ib, Phase II part 1 / from randomization: Phase II part 2 Cohort A through study completion, for an average of 4.5 years. | Phase Ib: All participants included and who received any amount of study treatment.~Phase II part 1: Evaluable participants' population. Phase II part 2 Cohort A: All randomized participants who were administered at least one dose of IMP(s) according to the treatment allocated at randomization.~For the Phase II part 2 Cohort B, the outcome measure Overall Survival has not been defined as secondary endpoint. Therefore Phase II part 2 Cohort B is not included in the analysis population. | Months | MEDIAN |
| SECONDARY | Duration of Overall Response (DoR): Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A | From treatment start Phase Ib, Phase II part 1 / from randomization Phase II part 2 Cohort A : every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 2.5 years. | For phase Ib, phase II part 1 and phase II part 2 Cohort A, analysis population consists of all included participants who were dosed with IMP(s) according to treatment allocation and who have a confirmed response according to RECIST1.1.~For Phase II part 2 Cohort B, the outcome measure duration of overall response has not been defined as secondary endpoint. Therefore Phase II part 2 cohort B is not included in the analysis population. | Weeks | MEDIAN |
| SECONDARY | Proportion of Progressive Disease Phase II Part 2 Cohort B | From randomization: every 6 weeks up to 24 weeks. | Phase II part 2 Cohort B: All randomized participants administered with at least one dose of IMP(s) according to allocation at randomization (FAS). One participant (cohort B - Avelumab) was excluded from analysis because no IMP has been administered.~Phase Ib, Phase II part 1 and Phase II part 2 Cohort A, proportion of progressive disease has not been defined as secondary endpoint. Therefore phase Ib, Phase II part 1 and Phase II part 2 Cohort A are not included in the analysis population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| 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 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I - TG4001 5x10e6 Pfu + Avelumab | 3 | |
| Overall Study | STARTED | Phase I - TG4001 5x10e7 Pfu + Avelumab | 6 | |
| Overall Study | STARTED | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 34 | |
| Overall Study | STARTED | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 46 | |
| Overall Study | STARTED | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 44 | |
| Overall Study | STARTED | Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 5 | |
| Overall Study | STARTED | Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 5 | |
| Overall Study | COMPLETED | Phase I - TG4001 5x10e6 Pfu + Avelumab | 3 | |
| Overall Study | COMPLETED | Phase I - TG4001 5x10e7 Pfu + Avelumab | 5 | |
| Overall Study | COMPLETED | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 25 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events3,255
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase I - TG4001 5x10e6 Pfu + Avelumab | 2 | 3 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I - TG4001 5x10e7 Pfu + Avelumab | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 15 | 34 | 26 |
| other | Anaemia | Blood and lymphatic system disorders | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 17 | 46 | 43 |
| other | Anaemia | Blood and lymphatic system disorders | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 13 | 44 | 29 |
| other | Anaemia | Blood and lymphatic system disorders | Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab | 2 | 5 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 0 | 4 | 0 |
| other | Antiphospholipid syndrome | Blood and lymphatic system disorders | Phase I - TG4001 5x10e6 Pfu + Avelumab | 0 | 3 | 0 |
| other | Antiphospholipid syndrome | Blood and lymphatic system disorders | Phase I - TG4001 5x10e7 Pfu + Avelumab | 0 | 6 | 0 |
| other | Antiphospholipid syndrome | Blood and lymphatic system disorders | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 1 | 34 | 1 |
1 to 10 of 3,255Source ClinicalTrials.gov
See all 3,255 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - TG4001 5x10e6 Pfu + Avelumab | 1 | 3 |
| Total, all-cause mortality | Phase I - TG4001 5x10e7 Pfu + Avelumab | 0 | 6 |
| Total, all-cause mortality | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 12 | 34 |
| Total, all-cause mortality | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 7 | 46 |
| Total, all-cause mortality | Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 5 | 44 |
| Total, all-cause mortality | Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab | 1 | 5 |
| Total, all-cause mortality | Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 0 | 4 |
| Total, other adverse events | Phase I - TG4001 5x10e6 Pfu + Avelumab | 3 | 3 |
| Total, other adverse events | Phase I - TG4001 5x10e7 Pfu + Avelumab | 6 | 6 |
| Total, other adverse events | Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 34 | 34 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37506588 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03260023
GET https://conductscience.org/api/trials/v1/NCT03260023/results?page=2