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NCT05681039 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC).
A Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT05681039: Recruiting Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT05681039 is a Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05681039, a Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
To learn if treatment with tiragolumab and atezolizumab before and after standard of care surgery and chemoradiation (radiation therapy with or without cisplatin/carboplatin) can help to control OCSCC that is PD-L1 CPS positive.
Primary Outcome
To determine the major pathological response rate, defined as \<10% viable tumor in the resection specimen, after two cycles of neoadjuvant atezolizumab and tiragolumab in patients with newly diagnosed, local-regionally advanced OCSCC that is PD-L1 CPS ≥1. Response at the primary site and in nodal disease will be evaluated
Conditions Studied
Interventions
- DRUG Atezolizumab
- BEHAVIORAL Questionnaires
- BEHAVIORAL Standard of Care
- DRUG Tiragolumab
- RADIATION Cisplatin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 2 |
What NCT05681039 shows while recruiting
NCT05681039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT05681039 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05681039 about?
NCT05681039 is a clinical study titled "Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC).". To learn if treatment with tiragolumab and atezolizumab before and after standard of care surgery and chemoradiation (radiation therapy with or without cisplatin/carboplatin) can help to control OCSCC that is PD-L1 CPS positive.
What is the current status of trial NCT05681039?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2023-06-02. Estimated completion is 2026-11-01.
What conditions does trial NCT05681039 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05681039?
The interventions under investigation include: Atezolizumab (DRUG), Questionnaires (BEHAVIORAL), Standard of Care (BEHAVIORAL), Tiragolumab (DRUG), Cisplatin (RADIATION).
Who is sponsoring clinical trial NCT05681039?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05681039 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05681039's enrollment target sits among peer trials
29 35th of 47 higher than 12 of 47 other Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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