Trials / Active Not Recruiting
Active Not RecruitingNCT05980000
Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma
Open-Label, Randomized Phase 2 Trial of Ramucirumab in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-Line Treatment of PD-L1 Positive, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma (RM-HNSCC)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2 study investigating the efficacy of ramucirumab in combination with pembrolizumab compared to pembrolizumab monotherapy. Ramucirumab is a VEGFR-2 inhibitor believed to potentially enhance the efficacy of PD-1 inhibitors such as pembrolizumab.
Conditions
- Recurrent Head and Neck Cancer
- Recurrent Head and Neck Squamous Cell Carcinoma
- Recurrent Head and Neck Carcinoma
- Metastatic Head-and-neck Squamous-cell Carcinoma
- Metastatic Head and Neck Cancer
- HNSCC
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ramucirumab | Ramucirumab is administered at a dose of 10 mg/kg over 60 minutes. |
| DRUG | Pembrolizumab | Pembrolizumab is administered at a flat dose of 200 mg over 30 minutes. |
Timeline
- Start date
- 2023-10-27
- Primary completion
- 2027-06-30
- Completion
- 2030-06-30
- First posted
- 2023-08-07
- Last updated
- 2026-03-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05980000. Inclusion in this directory is not an endorsement.