TrialStudy of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
Trial details
- Registry ID
- NCT04260126
- Phase
- Phase 2
PDSB
PDS Biotechnology Corp.
Company identity checked against sources
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2Trials in this database
12Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
Completion dates · Pro
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Included trials
Check company identity source| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCCNCT04260126 | PDSB | Phase 2 | Completed | 2025-05-14Actual |
| Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaNCT06790966 | PDSB | Phase 3 | Terminated | 2026-08-25Actual |
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Trial details
- Registry ID
- NCT06790966
- Phase
- Phase 3
Latest recorded trial changes
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
NCT06790966 · PDS Biotechnology Corp.
Participant count type changed
− Before
Estimated
+ After
Actual
Enrollment · participant count changed
− Before
252 participants (planned)
+ After
12 participants (actual)
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Feb 2029
+ After
25 Aug 2026
Recruitment status changed
− Before
Active not recruiting
+ After
Terminated
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
NCT06790966 · PDS Biotechnology Corp.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Overall Survival (OS)
+ After
Measure: Overall Survival (OS) Measure: Progression-Free Survival (PFS)
Planned enrollment decreased by 99 participants
− Before
351 participants (planned)
+ After
252 participants (planned)
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
NCT06790966 · PDS Biotechnology Corp.
Recruitment status changed
− Before
Recruiting
+ After
Active not recruiting
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
NCT04260126 · PDS Biotechnology Corp.
Participant count type changed
− Before
Estimated
+ After
Actual
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Jun 2025
+ After
14 May 2025
Recruitment status changed
− Before
Active not recruiting
+ After
Completed